Alcohol DrinkingNCT03917875
Computer-Delivered PFI for Anxiety Sensitivity/Alcohol Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity
A study testing Personalized feedback intervention in people with Alcohol Drinking and Anxiety, run by University of Houston at 1 site in United States.
Trial summary
Hazardous alcohol consumption is one of the leading causes of preventable deaths in the United States. Further, it is highly comorbid with anxiety and depressive symptoms and disorders; hazardous alcohol use is associated with increased anxiety/depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Anxiety, Coping Behavior
- What is being tested?
- Personalized feedback intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2016to 31 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elevated anxiety sensitivity, hazardous drinking
Who cannot join
- current mental health/substance treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-Delivered Personalized Feedback Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity
Hazardous alcohol consumption is one of the leading causes of preventable deaths in the United States. Further, it is highly comorbid with anxiety and depressive symptoms and disorders; hazardous alcohol use is associated with increased anxiety/depression. Indeed, 'affectively-vulnerable hazardous drinkers' (i.e., drinkers with elevated negative mood states or psychopathology) are 'at risk' for higher drinking rates, more problematic drinking, worsened mental health, and greater disability. Specialty care options are needed to address the unique 'affective needs' of hazardous drinkers. One promising intervention approach is to employ personalized feedback interventions (PFI). These interventions are brief, efficient, and have been shown to be effective in a number of settings and across an array of populations. However, PFIs have not been evaluated among affectively vulnerable hazardous drinkers.
In order to address the heterogeneity of negative mood states and disorders among hazardous drinkers, there is a need to theoretically orient the intervention approach on underlying transdiagnostic processes that underpin affective psychopathology. Anxiety sensitivity (AS), the tendency to fear anxiety-related sensations, is a core transdiagnostic vulnerability factor underlying the etiology and maintenance of anxiety disorders, other emotional disorders, and hazardous drinking. AS is malleable in response to psychosocial interventions, making it a prime risk factor to target in prevention/intervention programs, including PFI approaches. Integrated treatments that address hazardous drinking via AS are nonexistant. As most hazardous drinkers typically do not access treatment because of such barriers as cost, time commitments, stigma, and logistics (e.g., travel, scheduling appointments), there is a need to develop an accessible, brief, integrated tool to explicitly address the drinking-affective vulnerability comorbidity via AS. To address this public health gap, the current proposal seeks to employ a computer-delivered integrated PFI that directly addresses hazardous drinking-AS in a personalized manner. Hazardous drinkers with elevated AS will be randomly assigned to receive one session of PFI or attention information control with follow-up assessments at one week and one month post-intervention. The PFI will focus on targeted feedback about drinking behaviors, AS, and adaptive coping strategies.
- Conditions
- Alcohol Drinking, Anxiety, Coping Behavior
- Being tested
- Personalized feedback intervention
- Medical subject headings
- Alcohol Drinking, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized feedback interventionBehavioural
The novel integrated PFI will be developed and modeled from past PFIs targeting hazardous drinking. Participants will view feedback on the computer screen. The computer program/algorithm will determine the proper normative feedback to participants.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| PFI | Experimental | Not described Receives: Behavioral: Personalized feedback intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation for change
The Alcohol Ladder (Clair et al., 2011). The Alcohol Ladder is a reliable and valid (Hogue, Dauber, \& Morgenstern, 2010) measure of motivation to change alcohol use. It contains 10 statements that correspond to stages of change: pre-contemplation (e.g., "I enjoy drinking and have decided I'll never change it. I have no interest in changing the way I drink"), contemplation (e.g., "I rarely think about changing the way I drink, and I have no plans to change it"), preparation (e.g., "I definitely plan to change my alcohol use, and I'm almost ready to make some plans about how to change"), action (e.g., "I have changed my drinking, but I still worry about slipping back. So I need to keep working on the changes I've made), and maintenance (e.g., "I have changed my drinking and will never go back to the way I drank before). Participants select the statement that best corresponds to their current stage of motivation regarding changes in their alcohol use.
Measured: 1 month
Drinks per occasion
Drinks per occasion will be assessed as a ratio of the number of drinks consumed in the past 30 days over the number of drinking occasions reported over the past 30 days.
Measured: 1 month
Anxiety Sensitivity
Anxiety Sensitivity sensitivity will be assessed with the Anxiety Sensitivity Index-3 (ASI-3; Taylor et al., 2007). The ASI-3 is an 18-item self-report measure of anxiety sensitivity. Items (e.g., "It scares me when my heart beats rapidly") are rated on a 5-point Likert-type scale from 0 (very little) to 4 (very much). Items are summed to a total score. The ASI-3 shows good convergent and discriminant validity (Taylor et al., 2007).
Measured: 1 month
Secondary outcomes (1)
Drinking to cope
Drinking to cope will be measured with the Drinking motives questionnaire-revised (DMQ-R; Cooper, 1994). The DMQ-R is a 20-item self-report measure of drinking motives. It contains four subscales: social, enhancement, social pressure/conformity, and coping with anxiety/depression. The coping subscale (e.g., "to forget your worries") will serve as the measure of drinking to cope with emotional symptoms.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Sep 2016
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DrinkingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Paulus, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917875
- Sponsor's protocol ID
- STUDY00001045
- Status last verified
- Feb 2020
- First submitted
- 5 Apr 2019
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-Delivered Personalized Feedback Intervention for Hazardous Drinkers With Elevated Anxiety Sensitivity
- ClinicalTrials.gov ID
- NCT03917875
- Acronym / sponsor ID
- STUDY00001045
- Conditions
- Alcohol Drinking, Anxiety, Coping Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Apr 2019 (actual)
- 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.
Hazardous alcohol consumption is one of the leading causes of preventable deaths in the United States. Further, it is highly comorbid with anxiety and depressive symptoms and disorders; hazardous alcohol use is associated with increased anxiety/depression. Indeed, 'affectively-vulnerable hazardous drinkers' (i.e., drinkers with elevated negative mood states or psychopathology) are 'at risk' for higher drinking rates, more problematic drinking, worsened mental health, and greater disability. Specialty care options are needed to address the unique 'affective needs' of hazardous drinkers. One promising intervention approach is to employ personalized feedback interventions (PFI). These interventions are brief, efficient, and have been shown to be effective in a number of settings and across an array of populations. However, PFIs have not been evaluated among affectively vulnerable hazardous drinkers.
In order to address the heterogeneity of negative mood states and disorders among hazardous drinkers, there is a need to theoretically orient the intervention approach on underlying transdiagnostic processes that underpin affective psychopathology. Anxiety sensitivity (AS), the tendency to fear anxiety-related sensations, is a core transdiagnostic vulnerability factor underlying the etiology and maintenance of anxiety disorders, other emotional disorders, and hazardous drinking. AS is malleable in response to psychosocial interventions, making it a prime risk factor to target in prevention/intervention programs, including PFI approaches. Integrated treatments that address hazardous drinking via AS are nonexistant. As most hazardous drinkers typically do not access treatment because of such barriers as cost, time commitments, stigma, and logistics (e.g., travel, scheduling appointments), there is a need to develop an accessible, brief, integrated tool to explicitly address the drinking-affective vulnerability comorbidity via AS. To address this public health gap, the current proposal seeks to employ a computer-delivered integrated PFI that directly addresses hazardous drinking-AS in a personalized manner. Hazardous drinkers with elevated AS will be randomly assigned to receive one session of PFI or attention information control with follow-up assessments at one week and one month post-intervention. The PFI will focus on targeted feedback about drinking behaviors, AS, and adaptive coping strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| PFI | Experimental | Behavioral: Personalized feedback intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elevated anxiety sensitivity, hazardous drinking
Key exclusion criteria (1 listed)
- current mental health/substance treatment
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 |
|---|---|---|
| Personalized feedback interventionThe novel integrated PFI will be developed and modeled from past PFIs targeting hazardous drinking. Participants will view feedback on the computer screen. The computer program/algorithm will determine the proper normative feedback to participants. | Behavioural | PFI |
Primary outcome
Motivation for change
Time frame: 1 month
The Alcohol Ladder (Clair et al., 2011). The Alcohol Ladder is a reliable and valid (Hogue, Dauber, \& Morgenstern, 2010) measure of motivation to change alcohol use. It contains 10 statements that correspond to stages of change: pre-contemplation (e.g., "I enjoy drinking and have decided I'll never change it. I have no interest in changing the way I drink"), contemplation (e.g., "I rarely think about changing the way I drink, and I have no plans to change it"), preparation (e.g., "I definitely plan to change my alcohol use, and I'm almost ready to make some plans about how to change"), action (e.g., "I have changed my drinking, but I still worry about slipping back. So I need to keep working on the changes I've made), and maintenance (e.g., "I have changed my drinking and will never go back to the way I drank before). Participants select the statement that best corresponds to their current stage of motivation regarding changes in their alcohol use.
Drinks per occasion
Time frame: 1 month
Drinks per occasion will be assessed as a ratio of the number of drinks consumed in the past 30 days over the number of drinking occasions reported over the past 30 days.
Anxiety Sensitivity
Time frame: 1 month
Anxiety Sensitivity sensitivity will be assessed with the Anxiety Sensitivity Index-3 (ASI-3; Taylor et al., 2007). The ASI-3 is an 18-item self-report measure of anxiety sensitivity. Items (e.g., "It scares me when my heart beats rapidly") are rated on a 5-point Likert-type scale from 0 (very little) to 4 (very much). Items are summed to a total score. The ASI-3 shows good convergent and discriminant validity (Taylor et al., 2007).
1 secondary outcome
Drinking to cope
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized feedback intervention in people with Alcohol Drinking and Anxiety, run by University of Houston at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Motivation for change (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2020.