Alcohol ConsumptionNCT02927132
Guilt and Expressive Writing for Reducing Alcohol Use in College Students
A study testing Expressive Writing and Personalized Normative Feedback in people with Alcohol Consumption, run by University of Houston.
Trial summary
This research seeks to evaluate expressive writing as a novel intervention for problem drinking among college students. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to finer… Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Alcohol Consumption
- What is being tested?
- Expressive Writing and Personalized Normative Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Being between 18-26 years of age
- Being a registered UH student.
- Scoring 5+ and 7+ on the AUDIT-C for women/men respectively
- Being 18-26 years of age
- Being a registered UH student
- Providing consent to participate in the study
Who cannot join
- Not meeting inclusion criteria (i.e., not between 18-26 years of age, not a registered UH student)or unwillingness to participate.
- Not meeting any of the inclusion criteria, unwillingness to participate, and failure to provide consent.
About this study
This research seeks to evaluate expressive writing as a novel intervention for problem drinking among college students. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to finer distinctions of these, which require assessment and programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy.
H1a: Participants writing about negative drinking events will show reduced drinking and drinking-related negative consequences relative to students in the neutral control group.
Read more
H1b: Participants writing about distressing non-alcohol events will show increased psychological wellbeing relative to students in the neutral control group.
H1c: Participants writing about negative drinking events will show reduced drinking and consequences compared with an empirically-supported brief intervention (i.e., PNF). This is an exploratory hypothesis.
H2a: Alcohol narratives will have stronger effects on alcohol outcomes relative to distress narratives.
H2b: Alcohol guilt narratives will have the strongest effect on alcohol outcomes relative to all other conditions.
H3a: Expression of guilt, assessed by self-report and by content coding with LIWC, will mediate intervention effects on drinking outcomes.
H3b: Change thought, assessed by LIWC coding, will mediate intervention effects on drinking.
Read the detailed description
The current research builds on previous research targeting heavy drinking among college students. A large volume of research has provided an impressive data base supporting one type of individually-focused alcohol intervention for this population (i.e., personalized feedback). The success of this paradigm has probably contributed to the dearth of consideration of alternative paradigms. Expressive writing is one such alternative, which has received extensive support in other domains but has only recently been considered as a potential intervention for heavy drinking. The preliminary data examining this approach is promising and provides a firm foundation for this efficacy trial. Further, this research incorporates novel theoretical constructs including the specific focus on guilt in expressive writing content as well as "change thought," as an analogue to the mechanism presumed to underlie motivational treatments for alcohol and other substance use disorders. The investigators plan to employ similar methods which have been used successfully in other large NIAAA funded trials evaluating brief interventions for heavy drinking college students.
This research consists of an intervention study to evaluate expressive writing as a brief intervention in reducing drinking and improving psychological well-being among college students. Participation in the study involves completion of a screening assessment, a baseline assessment, the intervention procedure, post-intervention assessment, and follow-up assessments at 1-, 3-, 6-, and 12-months. Heavy drinking college students (N = 600) will be randomly assigned to one of six conditions based on the 2 (alcohol vs. distress topics) × 2 (guilt vs. no guilt focus) + 1 (neutral control) + 1 (personalized normative feedback) design. Before completing the baseline survey, students will be randomly assigned to one of six study conditions, five of which involve writing during three sessions over the course of one month. Specifically, participants will be assigned to write about a heavy drinking event, a heavy drinking event that elicited guilt, a distressing event, a distressing event that elicited guilt, or their first day of college (neutral control condition).
Participants randomly assigned to the PNF condition will receive traditional personalized normative feedback regarding how their drinking compares with other students of the same gender at the university. The norms will come from a large recently completed alcohol survey conducted at the University of Houston examining social norms and alcohol prevention (R01AA014576). To maintain consistency across conditions, participants in the PNF condition will still come into the lab three times. They will receive feedback during the first intervention session and will be asked to complete the same narrative prompts as the neutral control condition for their second and third session. For individuals in the expressive writing conditions, there will be three narrative prompts to complete every week for three weeks, the first of which will occur following the baseline assessment. All baseline assessments, narrative intervention assignments, and immediate post-tests for all conditions will be conducted in-lab. All other assessments including screening and follow-up assessments will be completed remotely by web. The rationale for including a personalized normative feedback condition is to be able to compare the efficacy of expressive writing interventions with existing brief alcohol interventions. Thus, the present design allows not only for evaluation of efficacy relative to a control condition but also will evaluate comparative efficacy relative to an existing empirically-supported brief alcohol intervention.
Aims will be evaluated using multi-level regression analyses, often referred to as Hierarchical Linear Modeling (HLM) or mixed-effects modeling. With respect to evaluating main effects of experimental conditions on drinking, each participant will provide baseline, post-intervention, 1-month, 3-month, 6-month, and 12-month follow-up data. Hypotheses will be tested using specific contrast vectors, using a general linear hypothesis framework. The study consists of a (2×2+1+1) design, represented as a factorial design with the addition of a control group that will write about their first day of school and a computer-based PNF comparison group. Hypotheses will be tested with contrasts corresponding to the questions of interest. The first two hypotheses represent contrasts between the alcohol narrative conditions and the neutral control condition (H1a) and between the guilt narrative conditions and the neutral control condition (H1b). In examining these hypotheses, the investigators will construct two dummy coded variables reflecting alcohol versus non-alcohol narratives conditions and between guilt and non-guilt narrative conditions with the reference group being the neutral control condition. Thus, the PNF group will not be included in the tests of these two hypotheses. Dependent variables will include alcohol outcomes for H1a and psychological well-being for H1b. For these analyses each participant will provide up to 5 repeated measures (i.e., baseline, 1-month, 3-months, 6-months, and 12-months), yielding up to 3000 Level 1 cases (repeated-measures) across 600 Level 2 cases.
The investigators will also evaluate mediators of intervention effects. Additionally, the investigators will follow procedures to assess mediation. Mediation will test indirect effects using the AB products method where A will represent effects of intervention contrasts by time interactions on mediators (expression of guilt and change thought). B will represent the associations of mediators on subsequent drinking outcomes. Both A and B paths will control for baseline outcomes. Evaluation of hypotheses regarding the moderation effect will test whether individual differences in guilt-proneness interact with intervention contrasts. These will be tested by expanding the above model to add main effects and product terms of proposed moderators with intervention contrasts.
Power analyses focus on estimating a sample size large enough to detect "true" effects, thereby avoiding Type II errors. Sample size estimates were obtained for intervention contrasts. Necessary sample sizes were assessed via sample size and power equations for normally distributed outcomes. Effect-sizes and variance components were based on preliminary studies, and power was set at 0.80 for all estimates. Power was estimated using the Optimal Design software program. The investigators anticipate intervention effects relative to the neutral control condition on drinking to be in the range of delta =.30-.40). Based on the proposed sample size of 500 (~PNF not included in H1a and H1b), given five assessment points, the investigators anticipate the ability to detect main effects of intervention contrasts with power=.80. Considering maximum anticipated attrition rates of 20% the investigators will have .80 power to detect effects sizes of delta = .28 and greater.
- Conditions
- Alcohol Consumption
- Being tested
- Expressive Writing, Personalized Normative Feedback
- Keywords
- Drinking, Alcohol
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingBehavioural
Expressive writing is a brief intervention that has been linked to various health and social benefits. Expressing emotions through writing can lead to decreased levels of stress and negative affect, thereby serving as a coping mechanism. Furthermore, expressive writing allows participants to reconstruct their traumatic experiences and reorganize their memory of these events into a narrative. Expressive writing has been used to target drinking. Research has found that students have reduced drinking intentions after writing about a negative drinking event compared to control,suggesting that a narrative intervention may be effective in reducing drinking. Other research suggests that feelings of guilt were more strongly associated with intentions to reduce drinking after writing about a negative drinking event, and that this event-related guilt mediated intervention effects.
Personalized Normative FeedbackBehavioural
PNF approaches use information designed to correct normative misperceptions to reduce heavy drinking. Three pieces of information are necessary when providing personalized normative feedback: information about a student's own drinking, information about the student's perceptions of others' drinking, and information about others' actual drinking. The presentation of this information is designed to change students' perceptions of "normal" drinking by exposing their misperceptions of the norm as well as by comparing their behavior with "normal" behavior.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-Guilt Condition | Experimental | In this condition, participants are asked to write about an incident in which they drank heavily and experienced guilt.
Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. Receives: Behavioral: Expressive Writing |
| Distress-Guilt Condition | Experimental | In this condition, participants are asked to write about an upsetting incident where they experienced guilt.
Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. Receives: Behavioral: Expressive Writing |
| Alcohol-No Guilt Condition | Experimental | In this condition, participants are asked to write about a negative drinking incident that they had experienced.
Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. Receives: Behavioral: Expressive Writing |
| Distress-No Guilt Condition | Experimental | In this condition, participants are asked to write about an upsetting experience that has affected their life.
Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. Receives: Behavioral: Expressive Writing |
| Neutral Control Condition | No intervention | In this condition, participants are asked to write about the laboratory room in which they are seated. Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. |
| Personalized Normative Feedback | Experimental | Participants in the PNF condition will be given gender-specific personalized feedback regarding their alcohol use. Participants will be presented with the drinking estimates that they previously gave in addition to average gender-specific drinking estimates provided by 1124 students at the University of Houston. Feedback will be provided for drinking frequency (i.e., number of drinking days per week), and drinking quantity (i.e., the number of drinks consumed per week and number of drinks consumed per typical drinking occasion). Participants will also receive a printed a copy of the feedback for their records. PNF participants will receive feedback immediately after the baseline assessment. We also wanted to control for any differences that might be attributed to attention. Thus, participants will be scheduled to come in to the lab for two more sessions, during which time they will write about the laboratory room in which they are seated. Receives: Behavioral: Personalized Normative Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Consumption measured by The Timeline Follow-Back (TLFB)
The TLFB is a calendar based measure assessing daily drinking (and abstinence) over a designated period of time.
Number of drinks in the past month will be calculated as the sum of drinks recorded each day of the past month on the TLFB.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in Drinking Intentions as measured by a modified version of the Daily Drinking Questionnaire (DDQ).
Response options will be identical to the DDQ, but participants will be asked to indicate their intended drinking behaviors.
Participants fill in the average number of standard drinks they intend to consume for each day of the week over the next month. Typical number of intended drinks per week will be calculated as the sum of typical number of drinks intended per day on the Daily Drinking Questionnaire.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in Alcohol Consumption measured by Alcohol Use Disorders Identification Test (AUDIT).
The AUDIT assesses for hazardous alcohol use, dependence symptoms, and harmful use. Scores for each question range from 0 to 4, with the first response for each question (e.g. never) scoring 0, the second (e.g. less than monthly) scoring 1, the third (e.g. monthly) scoring 2, the fourth (e.g. weekly) scoring 3, and the last response (e.g. daily or almost daily) scoring 4. For questions 9 and 10, which only have three responses, the scoring is 0, 2 and 4 (from left to right). A score of 8 or more is associated with harmful or hazardous drinking.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in Alcohol Consumption measured by Quantity-Frequency-Peak Alcohol Use Index.
The Quantity-Frequency-Peak Alcohol Use Index is a five-item questionnaire that includes two items addressing the occasion where respondents drank the most during the previous three months, two items addressing typical weekend drinking in the previous three months, and one item addressing typical number of drinking days per week in the previous three months. Drinking frequency will be assessed by item #5 of the Quantity/Frequency Questionnaire, which asks how many days during the past week participants have consumed alcohol.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in Alcohol Consumption measured by the Daily Drinking Questionnaire (DDQ.
Typical weekly drinking and typical drinks per occasion will be assessed with the DDQ. Participants fill in the average number of standard drinks they consumed and the time period of consumption for each day of the week over the previous three months. Typical number of drinks per week will be calculated as the sum of typical number of drinks per day on the Daily Drinking Questionnaire.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Change in Drinking Intentions as measured by a modified version of the Quantity-Frequency-Peak Alcohol Use Index (QF).
Response options will be identical to the QF, but participants will be asked to indicate their intended drinking behaviors. Intended drinking frequency will be assessed by item #5 of the Quantity/Frequency Questionnaire, which asks how many days during the next week participants intend to consume alcohol.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Changes in Psychological Well-being Outcomes as measured by the Center for Epidemiological Studies Depression Scale (CES-D)
Depression will be assessed by the Ces-D, a 20-item measure of depressive symptomatology in the general population. Answers are on a scale of 1 (rarely) to 4 (most or all of the time). A score of 11 is indicative of significant or mild depressive symptomology, and higher scores are indicative of greater symptoms.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Changes in Psychological Well-being Outcomes as measured by Positive and Negative Affect Scale (PANAS)
Mood will be assessed by the PANAS, a 22-item measure of the degree to which one experiences positive and negative affective states on a regular basis.
For a positive affect score, items 1 (interested), 3 (excited), 5 (strong), 9 (enthusiastic), 10 (proud), 12 (alert), 14 (inspired), 16 (determined), 17 (attentive), and 19 (active) will be added, with higher scores representing higher levels of positive affect.
For a negative affect score, items 2 (distressed), 4 (upset), 6 (guilty), 7 (scared), 8 (hostile), 11 (irritable), 13 (ashamed), 15 (nervous), 18 (jittery) and 20 (afraid) will be added, with lower scores representing lower levels of negative affect.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Changes in Psychological Well-being Outcomes as measured by Satisfaction with Life Scale (SWLS).
This short, 5-item measure is designed to measure cognitive judgments of satisfaction with one's life. Each item is rated on a scale of 1 (strongly disagree) to 7 (strongly agree). A score of 31-35 indicates that a participant is extremely satisfied, a score of 26-30 indicates that a participant is satisfied, a score of 21-25 indicates that a participant is slightly satisfied, a score of 20 indicates that a participant is neutral, a score of 15-19 indicates that a participant is slightly dissatisfied, a score of 10-14 indicates that a participant is dissatisfied, and a score of 5-9 indicates that a participant is extremely dissatisfied.
Measured: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (53)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Clayton Neighbors, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927132
- Sponsor's protocol ID
- 3660702
- Other IDs
- 1R01AA023495-01
- Status last verified
- Jun 2018
- First submitted
- 26 May 2016
- Last updated
- 20 Jun 2018
- Results posted
- No
- Individual data sharing
- No
Publications
Ames SC, Patten CA, Offord KP, Pennebaker JW, Croghan IT, Tri DM, Stevens SR, Hurt RD. Expressive writing intervention for young adult cigarette smokers. J Clin Psychol. 2005 Dec;61(12):1555-70. doi: 10.1002/jclp.20208.
PubMed 16193479Ames SC, Patten CA, Werch CE, Schroeder DR, Stevens SR, Fredrickson PA, Echols JD, Pennebaker JW, Hurt RD. Expressive writing as a smoking cessation treatment adjunct for young adult smokers. Nicotine Tob Res. 2007 Feb;9(2):185-94. doi: 10.1080/14622200601078525.
PubMed 17365749Amrhein PC, Miller WR, Yahne CE, Palmer M, Fulcher L. Client commitment language during motivational interviewing predicts drug use outcomes. J Consult Clin Psychol. 2003 Oct;71(5):862-78. doi: 10.1037/0022-006X.71.5.862.
PubMed 14516235Baer JS, Marlatt GA, Kivlahan DR, Fromme K, Larimer ME, Williams E. An experimental test of three methods of alcohol risk reduction with young adults. J Consult Clin Psychol. 1992 Dec;60(6):974-9. doi: 10.1037//0022-006x.60.6.974.
PubMed 1460160Baikie KA, Geerligs L, Wilhelm K. Expressive writing and positive writing for participants with mood disorders: an online randomized controlled trial. J Affect Disord. 2012 Feb;136(3):310-9. doi: 10.1016/j.jad.2011.11.032. Epub 2011 Dec 30.
PubMed 22209127Barclay LJ, Skarlicki DP. Healing the wounds of organizational injustice: examining the benefits of expressive writing. J Appl Psychol. 2009 Mar;94(2):511-23. doi: 10.1037/a0013451.
PubMed 19271805Barnett NP, Goldstein AL, Murphy JG, Colby SM, Monti PM. "I'll never drink like that again": characteristics of alcohol-related incidents and predictors of motivation to change in college students. J Stud Alcohol. 2006 Sep;67(5):754-63. doi: 10.15288/jsa.2006.67.754.
PubMed 16847545Carey KB, Scott-Sheldon LA, Carey MP, DeMartini KS. Individual-level interventions to reduce college student drinking: a meta-analytic review. Addict Behav. 2007 Nov;32(11):2469-94. doi: 10.1016/j.addbeh.2007.05.004. Epub 2007 May 17.
PubMed 17590277Carey KB, Scott-Sheldon LA, Elliott JC, Bolles JR, Carey MP. Computer-delivered interventions to reduce college student drinking: a meta-analysis. Addiction. 2009 Nov;104(11):1807-19. doi: 10.1111/j.1360-0443.2009.02691.x. Epub 2009 Sep 10.
PubMed 19744139Chung CK, Pennebaker JW. Variations in the spacing of expressive writing sessions. Br J Health Psychol. 2008 Feb;13(Pt 1):15-21. doi: 10.1348/135910707X251171.
PubMed 18230224Collins SE, Carey KB. The theory of planned behavior as a model of heavy episodic drinking among college students. Psychol Addict Behav. 2007 Dec;21(4):498-507. doi: 10.1037/0893-164X.21.4.498.
PubMed 18072832Collins SE, Carey KB, Sliwinski MJ. Mailed personalized normative feedback as a brief intervention for at-risk college drinkers. J Stud Alcohol. 2002 Sep;63(5):559-67. doi: 10.15288/jsa.2002.63.559.
PubMed 12380852Craft MA, Davis GC, Paulson RM. Expressive writing in early breast cancer survivors. J Adv Nurs. 2013 Feb;69(2):305-15. doi: 10.1111/j.1365-2648.2012.06008.x. Epub 2012 Apr 11.
PubMed 22494086Cronce, J. M., & Larimer, M. E. (2012). Brief individual-focused alcohol interventions for college students. In H. White, D. L. Rabiner (Eds.), College drinking and drug use (pp. 161-183). New York, NY US: Guilford Press.
Dearing RL, Stuewig J, Tangney JP. On the importance of distinguishing shame from guilt: relations to problematic alcohol and drug use. Addict Behav. 2005 Aug;30(7):1392-404. doi: 10.1016/j.addbeh.2005.02.002. Epub 2005 Apr 13.
PubMed 16022935
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guilt and Expressive Writing for Reducing Alcohol Use in College Students
- ClinicalTrials.gov ID
- NCT02927132
- Acronym / sponsor ID
- 3660702
- Conditions
- Alcohol Consumption
- Keywords
- Drinking, Alcohol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research seeks to evaluate expressive writing as a novel intervention for problem drinking among college students. The vast majority of individually focused brief interventions targeting college drinking have focused on personalized feedback approaches and recent innovations have largely been limited to finer distinctions of these, which require assessment and programming for implementation. The present research proposes expressive writing as a novel alternative, which has been used extensively in other domains but not as an alcohol intervention strategy.
H1a: Participants writing about negative drinking events will show reduced drinking and drinking-related negative consequences relative to students in the neutral control group.
H1b: Participants writing about distressing non-alcohol events will show increased psychological wellbeing relative to students in the neutral control group.
H1c: Participants writing about negative drinking events will show reduced drinking and consequences compared with an empirically-supported brief intervention (i.e., PNF). This is an exploratory hypothesis.
H2a: Alcohol narratives will have stronger effects on alcohol outcomes relative to distress narratives.
H2b: Alcohol guilt narratives will have the strongest effect on alcohol outcomes relative to all other conditions.
H3a: Expression of guilt, assessed by self-report and by content coding with LIWC, will mediate intervention effects on drinking outcomes.
H3b: Change thought, assessed by LIWC coding, will mediate intervention effects on drinking.
Detailed description
The current research builds on previous research targeting heavy drinking among college students. A large volume of research has provided an impressive data base supporting one type of individually-focused alcohol intervention for this population (i.e., personalized feedback). The success of this paradigm has probably contributed to the dearth of consideration of alternative paradigms. Expressive writing is one such alternative, which has received extensive support in other domains but has only recently been considered as a potential intervention for heavy drinking. The preliminary data examining this approach is promising and provides a firm foundation for this efficacy trial. Further, this research incorporates novel theoretical constructs including the specific focus on guilt in expressive writing content as well as "change thought," as an analogue to the mechanism presumed to underlie motivational treatments for alcohol and other substance use disorders. The investigators plan to employ similar methods which have been used successfully in other large NIAAA funded trials evaluating brief interventions for heavy drinking college students.
This research consists of an intervention study to evaluate expressive writing as a brief intervention in reducing drinking and improving psychological well-being among college students. Participation in the study involves completion of a screening assessment, a baseline assessment, the intervention procedure, post-intervention assessment, and follow-up assessments at 1-, 3-, 6-, and 12-months. Heavy drinking college students (N = 600) will be randomly assigned to one of six conditions based on the 2 (alcohol vs. distress topics) × 2 (guilt vs. no guilt focus) + 1 (neutral control) + 1 (personalized normative feedback) design. Before completing the baseline survey, students will be randomly assigned to one of six study conditions, five of which involve writing during three sessions over the course of one month. Specifically, participants will be assigned to write about a heavy drinking event, a heavy drinking event that elicited guilt, a distressing event, a distressing event that elicited guilt, or their first day of college (neutral control condition).
Participants randomly assigned to the PNF condition will receive traditional personalized normative feedback regarding how their drinking compares with other students of the same gender at the university. The norms will come from a large recently completed alcohol survey conducted at the University of Houston examining social norms and alcohol prevention (R01AA014576). To maintain consistency across conditions, participants in the PNF condition will still come into the lab three times. They will receive feedback during the first intervention session and will be asked to complete the same narrative prompts as the neutral control condition for their second and third session. For individuals in the expressive writing conditions, there will be three narrative prompts to complete every week for three weeks, the first of which will occur following the baseline assessment. All baseline assessments, narrative intervention assignments, and immediate post-tests for all conditions will be conducted in-lab. All other assessments including screening and follow-up assessments will be completed remotely by web. The rationale for including a personalized normative feedback condition is to be able to compare the efficacy of expressive writing interventions with existing brief alcohol interventions. Thus, the present design allows not only for evaluation of efficacy relative to a control condition but also will evaluate comparative efficacy relative to an existing empirically-supported brief alcohol intervention.
Aims will be evaluated using multi-level regression analyses, often referred to as Hierarchical Linear Modeling (HLM) or mixed-effects modeling. With respect to evaluating main effects of experimental conditions on drinking, each participant will provide baseline, post-intervention, 1-month, 3-month, 6-month, and 12-month follow-up data. Hypotheses will be tested using specific contrast vectors, using a general linear hypothesis framework. The study consists of a (2×2+1+1) design, represented as a factorial design with the addition of a control group that will write about their first day of school and a computer-based PNF comparison group. Hypotheses will be tested with contrasts corresponding to the questions of interest. The first two hypotheses represent contrasts between the alcohol narrative conditions and the neutral control condition (H1a) and between the guilt narrative conditions and the neutral control condition (H1b). In examining these hypotheses, the investigators will construct two dummy coded variables reflecting alcohol versus non-alcohol narratives conditions and between guilt and non-guilt narrative conditions with the reference group being the neutral control condition. Thus, the PNF group will not be included in the tests of these two hypotheses. Dependent variables will include alcohol outcomes for H1a and psychological well-being for H1b. For these analyses each participant will provide up to 5 repeated measures (i.e., baseline, 1-month, 3-months, 6-months, and 12-months), yielding up to 3000 Level 1 cases (repeated-measures) across 600 Level 2 cases.
The investigators will also evaluate mediators of intervention effects. Additionally, the investigators will follow procedures to assess mediation. Mediation will test indirect effects using the AB products method where A will represent effects of intervention contrasts by time interactions on mediators (expression of guilt and change thought). B will represent the associations of mediators on subsequent drinking outcomes. Both A and B paths will control for baseline outcomes. Evaluation of hypotheses regarding the moderation effect will test whether individual differences in guilt-proneness interact with intervention contrasts. These will be tested by expanding the above model to add main effects and product terms of proposed moderators with intervention contrasts.
Power analyses focus on estimating a sample size large enough to detect "true" effects, thereby avoiding Type II errors. Sample size estimates were obtained for intervention contrasts. Necessary sample sizes were assessed via sample size and power equations for normally distributed outcomes. Effect-sizes and variance components were based on preliminary studies, and power was set at 0.80 for all estimates. Power was estimated using the Optimal Design software program. The investigators anticipate intervention effects relative to the neutral control condition on drinking to be in the range of delta =.30-.40). Based on the proposed sample size of 500 (~PNF not included in H1a and H1b), given five assessment points, the investigators anticipate the ability to detect main effects of intervention contrasts with power=.80. Considering maximum anticipated attrition rates of 20% the investigators will have .80 power to detect effects sizes of delta = .28 and greater.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Alcohol-Guilt Condition | Experimental | Behavioral: Expressive WritingIn this condition, participants are asked to write about an incident in which they drank heavily and experienced guilt. Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. |
| Distress-Guilt Condition | Experimental | Behavioral: Expressive WritingIn this condition, participants are asked to write about an upsetting incident where they experienced guilt. Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. |
| Alcohol-No Guilt Condition | Experimental | Behavioral: Expressive WritingIn this condition, participants are asked to write about a negative drinking incident that they had experienced. Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. |
| Distress-No Guilt Condition | Experimental | Behavioral: Expressive WritingIn this condition, participants are asked to write about an upsetting experience that has affected their life. Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. |
| Neutral Control Condition | No intervention | –In this condition, participants are asked to write about the laboratory room in which they are seated. Participants in this condition will come into the lab one time each week for three weeks to complete the writing task. They will then complete follow-up surveys remotely, at 1 month, 3 months, 6 months, and 12 months. |
| Personalized Normative Feedback | Experimental | Behavioral: Personalized Normative FeedbackParticipants in the PNF condition will be given gender-specific personalized feedback regarding their alcohol use. Participants will be presented with the drinking estimates that they previously gave in addition to average gender-specific drinking estimates provided by 1124 students at the University of Houston. Feedback will be provided for drinking frequency (i.e., number of drinking days per week), and drinking quantity (i.e., the number of drinks consumed per week and number of drinks consumed per typical drinking occasion). Participants will also receive a printed a copy of the feedback for their records. PNF participants will receive feedback immediately after the baseline assessment. We also wanted to control for any differences that might be attributed to attention. Thus, participants will be scheduled to come in to the lab for two more sessions, during which time they will write about the laboratory room in which they are seated. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Being between 18-26 years of age
- Being a registered UH student.
- Scoring 5+ and 7+ on the AUDIT-C for women/men respectively
- Being 18-26 years of age
- Being a registered UH student
Key exclusion criteria (2 listed)
- Not meeting inclusion criteria (i.e., not between 18-26 years of age, not a registered UH student)or unwillingness to participate.
- Not meeting any of the inclusion criteria, unwillingness to participate, and failure to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive WritingExpressive writing is a brief intervention that has been linked to various health and social benefits. Expressing emotions through writing can lead to decreased levels of stress and negative affect, thereby serving as a coping mechanism. Furthermore, expressive writing allows participants to reconstruct their traumatic experiences and reorganize their memory of these events into a narrative. Expressive writing has been used to target drinking. Research has found that students have reduced drinking intentions after writing about a negative drinking event compared to control,suggesting that a narrative intervention may be effective in reducing drinking. Other research suggests that feelings of guilt were more strongly associated with intentions to reduce drinking after writing about a negative drinking event, and that this event-related guilt mediated intervention effects. | Behavioural | Alcohol-Guilt Condition, Alcohol-No Guilt Condition, Distress-Guilt Condition, Distress-No Guilt Condition |
| Personalized Normative FeedbackPNF approaches use information designed to correct normative misperceptions to reduce heavy drinking. Three pieces of information are necessary when providing personalized normative feedback: information about a student's own drinking, information about the student's perceptions of others' drinking, and information about others' actual drinking. The presentation of this information is designed to change students' perceptions of "normal" drinking by exposing their misperceptions of the norm as well as by comparing their behavior with "normal" behavior. | Behavioural | Personalized Normative Feedback |
Primary outcome
Change in Alcohol Consumption measured by The Timeline Follow-Back (TLFB)
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
The TLFB is a calendar based measure assessing daily drinking (and abstinence) over a designated period of time. Number of drinks in the past month will be calculated as the sum of drinks recorded each day of the past month on the TLFB.
Change in Drinking Intentions as measured by a modified version of the Daily Drinking Questionnaire (DDQ).
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Response options will be identical to the DDQ, but participants will be asked to indicate their intended drinking behaviors. Participants fill in the average number of standard drinks they intend to consume for each day of the week over the next month. Typical number of intended drinks per week will be calculated as the sum of typical number of drinks intended per day on the Daily Drinking Questionnaire.
Change in Alcohol Consumption measured by Alcohol Use Disorders Identification Test (AUDIT).
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
The AUDIT assesses for hazardous alcohol use, dependence symptoms, and harmful use. Scores for each question range from 0 to 4, with the first response for each question (e.g. never) scoring 0, the second (e.g. less than monthly) scoring 1, the third (e.g. monthly) scoring 2, the fourth (e.g. weekly) scoring 3, and the last response (e.g. daily or almost daily) scoring 4. For questions 9 and 10, which only have three responses, the scoring is 0, 2 and 4 (from left to right). A score of 8 or more is associated with harmful or hazardous drinking.
Change in Alcohol Consumption measured by Quantity-Frequency-Peak Alcohol Use Index.
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
The Quantity-Frequency-Peak Alcohol Use Index is a five-item questionnaire that includes two items addressing the occasion where respondents drank the most during the previous three months, two items addressing typical weekend drinking in the previous three months, and one item addressing typical number of drinking days per week in the previous three months. Drinking frequency will be assessed by item #5 of the Quantity/Frequency Questionnaire, which asks how many days during the past week participants have consumed alcohol.
Change in Alcohol Consumption measured by the Daily Drinking Questionnaire (DDQ.
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Typical weekly drinking and typical drinks per occasion will be assessed with the DDQ. Participants fill in the average number of standard drinks they consumed and the time period of consumption for each day of the week over the previous three months. Typical number of drinks per week will be calculated as the sum of typical number of drinks per day on the Daily Drinking Questionnaire.
Change in Drinking Intentions as measured by a modified version of the Quantity-Frequency-Peak Alcohol Use Index (QF).
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Response options will be identical to the QF, but participants will be asked to indicate their intended drinking behaviors. Intended drinking frequency will be assessed by item #5 of the Quantity/Frequency Questionnaire, which asks how many days during the next week participants intend to consume alcohol.
Changes in Psychological Well-being Outcomes as measured by the Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Depression will be assessed by the Ces-D, a 20-item measure of depressive symptomatology in the general population. Answers are on a scale of 1 (rarely) to 4 (most or all of the time). A score of 11 is indicative of significant or mild depressive symptomology, and higher scores are indicative of greater symptoms.
Changes in Psychological Well-being Outcomes as measured by Positive and Negative Affect Scale (PANAS)
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
Mood will be assessed by the PANAS, a 22-item measure of the degree to which one experiences positive and negative affective states on a regular basis. For a positive affect score, items 1 (interested), 3 (excited), 5 (strong), 9 (enthusiastic), 10 (proud), 12 (alert), 14 (inspired), 16 (determined), 17 (attentive), and 19 (active) will be added, with higher scores representing higher levels of positive affect. For a negative affect score, items 2 (distressed), 4 (upset), 6 (guilty), 7 (scared), 8 (hostile), 11 (irritable), 13 (ashamed), 15 (nervous), 18 (jittery) and 20 (afraid) will be added, with lower scores representing lower levels of negative affect.
Changes in Psychological Well-being Outcomes as measured by Satisfaction with Life Scale (SWLS).
Time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up
This short, 5-item measure is designed to measure cognitive judgments of satisfaction with one's life. Each item is rated on a scale of 1 (strongly disagree) to 7 (strongly agree). A score of 31-35 indicates that a participant is extremely satisfied, a score of 26-30 indicates that a participant is satisfied, a score of 21-25 indicates that a participant is slightly satisfied, a score of 20 indicates that a participant is neutral, a score of 15-19 indicates that a participant is slightly dissatisfied, a score of 10-14 indicates that a participant is dissatisfied, and a score of 5-9 indicates that a participant is extremely dissatisfied.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Background: PubMed 16193479Ames SC, Patten CA, Offord KP, Pennebaker JW, Croghan IT, Tri DM, Stevens SR, Hurt RD. Expressive writing intervention for young adult cigarette smokers. J Clin Psychol. 2005 Dec;61(12):1555-70. doi: 10.1002/jclp.20208.
- Background: PubMed 17365749Ames SC, Patten CA, Werch CE, Schroeder DR, Stevens SR, Fredrickson PA, Echols JD, Pennebaker JW, Hurt RD. Expressive writing as a smoking cessation treatment adjunct for young adult smokers. Nicotine Tob Res. 2007 Feb;9(2):185-94. doi: 10.1080/14622200601078525.
- Background: PubMed 14516235Amrhein PC, Miller WR, Yahne CE, Palmer M, Fulcher L. Client commitment language during motivational interviewing predicts drug use outcomes. J Consult Clin Psychol. 2003 Oct;71(5):862-78. doi: 10.1037/0022-006X.71.5.862.
- Background: PubMed 1460160Baer JS, Marlatt GA, Kivlahan DR, Fromme K, Larimer ME, Williams E. An experimental test of three methods of alcohol risk reduction with young adults. J Consult Clin Psychol. 1992 Dec;60(6):974-9. doi: 10.1037//0022-006x.60.6.974.
- Background: PubMed 22209127Baikie KA, Geerligs L, Wilhelm K. Expressive writing and positive writing for participants with mood disorders: an online randomized controlled trial. J Affect Disord. 2012 Feb;136(3):310-9. doi: 10.1016/j.jad.2011.11.032. Epub 2011 Dec 30.
- Background: PubMed 19271805Barclay LJ, Skarlicki DP. Healing the wounds of organizational injustice: examining the benefits of expressive writing. J Appl Psychol. 2009 Mar;94(2):511-23. doi: 10.1037/a0013451.
- Background: PubMed 16847545Barnett NP, Goldstein AL, Murphy JG, Colby SM, Monti PM. "I'll never drink like that again": characteristics of alcohol-related incidents and predictors of motivation to change in college students. J Stud Alcohol. 2006 Sep;67(5):754-63. doi: 10.15288/jsa.2006.67.754.
- Background: PubMed 17590277Carey KB, Scott-Sheldon LA, Carey MP, DeMartini KS. Individual-level interventions to reduce college student drinking: a meta-analytic review. Addict Behav. 2007 Nov;32(11):2469-94. doi: 10.1016/j.addbeh.2007.05.004. Epub 2007 May 17.
- Background: PubMed 19744139Carey KB, Scott-Sheldon LA, Elliott JC, Bolles JR, Carey MP. Computer-delivered interventions to reduce college student drinking: a meta-analysis. Addiction. 2009 Nov;104(11):1807-19. doi: 10.1111/j.1360-0443.2009.02691.x. Epub 2009 Sep 10.
- Background: PubMed 18230224Chung CK, Pennebaker JW. Variations in the spacing of expressive writing sessions. Br J Health Psychol. 2008 Feb;13(Pt 1):15-21. doi: 10.1348/135910707X251171.
- Background: PubMed 18072832Collins SE, Carey KB. The theory of planned behavior as a model of heavy episodic drinking among college students. Psychol Addict Behav. 2007 Dec;21(4):498-507. doi: 10.1037/0893-164X.21.4.498.
- Background: PubMed 12380852Collins SE, Carey KB, Sliwinski MJ. Mailed personalized normative feedback as a brief intervention for at-risk college drinkers. J Stud Alcohol. 2002 Sep;63(5):559-67. doi: 10.15288/jsa.2002.63.559.
- Individual participant dataSharing planned: No
Related trials for Alcohol Consumption
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive Writing and Personalized Normative Feedback in people with Alcohol Consumption, run by University of Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Consumption measured by The Timeline Follow-Back (TLFB) (time frame: Baseline, 1 month follow-up, 3 month follow-up, 6 month follow-up, 12 month follow-up). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02927132, which also lists 53 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.