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Alcohol Use Disorder, MildNCT05358613

My Choices: Efficacy and Implementation Study

A study testing My Choices in people with Alcohol Use Disorder, Mild and Alcohol Use, Unspecified, run by Université du Québec à Trois-Rivières at 5 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to assess the efficacy of the My Choices - Alcohol program by comparing alcohol-use of people before and after doing the program to people that did not do the program on the same period of time (3 months). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
My Choices
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
5 sitesCanada
Study dates
28 Oct 2021to 14 May 2023
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults with at risk alcohol use (alcohol use over the Canadian low-risk alcohol drinking guidelines, without or with low consequences associated with their alcohol use).

Who cannot join

  • Score at the DEBA (Assessment and Screening of Assistance needs) indicates a need for specialized treatment.
  • Hospitalization for mental health problems in the last 30 days
  • People with unstable mental health condition

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites
  • Centre Intégré Universitaire de Santé et de Services Sociaux du Saguenay-Lac-Saint-Jean

    Jonquière, Quebec, G7X 3A9

  • Centre Intégré de Santé Services Sociaux de Laval

    Laval, Quebec, H7M 3L9

  • Centre intégré de Santé et de Services Sociaux de Chaudière-Appalaches

    Lévis, Quebec, G6V 0M4

  • Centre Intégré Universitaire de Santé et de Services Sociaux de la Capitale-Nationale

    Québec, G1J 0A4

  • Université du Québec à Trois-Rivières

    Québec, G1M 3E5

Other trials in Canada

About this study

Official title: Early Intervention Programs for at Risk Use of Psychoactive Substances and Gambling: ''My Choices'' Family

The aim of the study is to assess the efficacy of the My Choices - Alcohol program by comparing alcohol-use of people before and after doing the program to people that did not do the program on the same period of time (3 months).

Read the detailed description

People with an alcohol addiction problem consume an average of 26.3 (sd = 12.4) drinks per week (Cournoyer et al., 2010). To observe a decrease of 25% in this average number of drinks for the group participating in the program " My Choices " immediately compared to the delayed group at 3 months, we need a sample size of 100 participants. This calculation assumes an alpha of 5%, a power of 80% and unbalanced groups due to the randomization method used. Considering an attrition rate of 11.3% at 3 months and 20% at 6 months (Tremblay et al., Submitted), it will be necessary to recruit at least 120 participants to maintain the required number for analyses.

References Cournoyer, L.-G., Simoneau, H., Landry, M., Tremblay, J., \& Patenaude, C. (2010). Évaluation d'implantation du programme Alcochoix+ (FQRSC #2008-TO-120890). F. q. d. r. s. l. s. e. l. culture.

Tremblay, J., Dufour, M., Bertrand, K., Saint-Jacques, M., Ferland, F., Blanchette-Martin, N., Savard, A.-C., Côté, M., Berbiche, D., \& Beaulieu, M. (Submitted). Efficacy of a Randomized Controlled Trial of Integrative Couple Treatment for Pathological Gambling (ICT-PG): 10-Month Follow-Up. Journal of Consulting and Clinical Psychology.

Being tested
My Choices
Keywords
Alcohol, Treatment
Medical subject headings
Alcoholism, Lymphoma, Follicular, Alcohol Drinking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My ChoicesBehavioural

    Also called Alcochoix+

    The My Choices program is an harm reduction program to modify substance use habits. It is based on the Miller \& Rollnick Motivational interviewing as well as Deci and Ryan's Self-determination theory and Bandura's social learning theory.

    It is presented as a guide, divided in 6 phases. In every phase, participants will find, in the guide, some auto-observation exercises about their alcohol use habits and other aspects about their quality of life, reflexions and information about alcohol. The participants are also invited to note the number of standard units of alcohol they use on every occasion.

Study groups in NCT05358613
Study groupRoleWhat they receive
Immediate treatmentExperimentalThe My Choices program will be offered immediately (maximum 10 working days from their first research interview) to the participants of this group. The treatment will be dispensed as usual, wich means there are no special conditions that need to be respected specifically for the study.
Receives: Behavioral: My Choices
Waiting listActive comparatorThe My Choices program will be offered 3 months after the first research interview to the participants in this group. The treatment will be dispensed as usual, wich means there are no special conditions that need to be respected specifically for the study.
Receives: Behavioral: My Choices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in self-reports of alcohol with the time-line follow-back (TLFB) in the last 90 days

    The timeline follow-Back is a research tool to obtain self-reported quantitatives estimates of alcohol used every day in the last 3 months in term of standard drink. (Sobell \& Sobell)

    Participants are asked in the first interview (2 weeks within eligibility evaluation) to remember day by day how many standard drinks they have had in the last 90 days.

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  2. Change in the Short Alcohol Dependance Data Questionnaire (SADD)

    Short Alcohol Dependence Data questionnaire (SADD) is used to measure the severity of alcohol dependence. It comprises 15 items with a four-point frequency scale (never,sometimes, often, nearly always). A total score between 0 and 45 is obtained by adding the score from each of the items. Scores between 0 - 9 indicates low dependence, scores between 10 - 19 indicates medium dependence and a score of 20 or more indicates high dependence.

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  3. Change in the Inventory of consequences associated with alcohol use

    It is a 7-items questionnaire, with a 0-10 (Never to always) scale that measures the consequences of alcohol consumption.

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  4. Change in the Severity of dependence scale (SDS)

    The Severity of Dependence Scale (SDS) is a 5-item self-administered questionnaire that provides a score indicating the severity of dependence on drugs with a 4-point scale from 0 (Never) to 3 (Always). Score 0 indicates no dependence, score between 1-2 indicates low dependence, score between 3-5 indicates moderate dependance and score between 6 and 15 indicates a high dependance.

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

Secondary outcomes (19)
  1. Satisfaction with Life Domains Scale

    20-items scale to assess the perceived quality of life. Participants can answer with 7 faces emojis (3 degrees of sadness, 3 degrees of happiness and 1 neutral).

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  2. Medical Outcomes Study-Social Support Survey (MOS-SSS)

    8-items scale (Domains tangible and Emotional support), with a 5-point Likert scale ranging from 0 (None) to 4 (All of the time).

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  3. Readiness to change

    12-items scale with a 5 point Likert scale ranging from strongly disagree (-2) to strongly agree (2).

    This questionnaire assesses the motivation level to change alcohol use habits. The levels used are those of the transtheoretical model of change (Prochaska \& DiClemente).

    The highest score indicates the stage in which the person is (precontemplation, contemplation or action) from a possibility from -8 to 8.

    Measured: 2 weeks within eligibility evaluation

  4. Motivations to change

    15-items scale with a 7 point Likert-like scale ranging from 1 (not at all) to 7 (Exactly) to assess the type of motivation that drives the person to modify his/her alcohol use habits.

    The questionnaire is based on the self-determination theory of Deci \& Ryan.

    It is possible to assess the coefficient of self-determination by adding up the score of the identified and introjected motivation, and substracting to that score the external and amotivation scores. The higher is the coefficient of self-determination, the more internal is the motivation.

    Measured: 2 weeks within eligibility evaluation

  5. Generalized Anxiety Disorder (GAD-7)

    Subjects are asked how often, during the last 2 weeks, they were bothered by each symptom. Response options were "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively (Löwe, Williams, Kroenke, Spitzer, 2006).

    A score between 0 and 4 means a minimal level of anxiety, between 5 and 9 means a mild level of anxiety, 10 to 14 means a moderate level of anxiety and a score between 15 and 21 means severe anxiety.

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  6. World Health Organization Well-Being Index (WHO-5)

    5-items scale with a 6 point Likert-like scale ranging from 0 (At no time) to 5 (All of the time). It is a subjective measure of the positive dimensions of mental health.

    Total score is between 0 to 100. Higher the score, better the level of well-being. A score under 50 could mean a higher risk of depression.

    Measured: 2 weeks within eligibility evaluation

  7. Impulsivity assessment with the Urgency, Premeditation (lack of), Perseverance (lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale, short version (UPPS-P short)

    It is a 20-items scale with a 4-point Likert-like scale from 1 (Agree strongly) to 4 (Disagree strongly).

    The items are representing 5 factors, which are negative and positive Urgency, sensation seeking, premedition (lack of) and perseverance (lack of).

    Scores are between 4 and 16 for each factor. The higher the score, the more impulsive is the person.

    Measured: 2 weeks within eligibility evaluation

  8. Attention disorder and hyperactivity disorder (ADHD) assesment

    6-items scale with a 5-point Likert-like scale from Never to Really often. If a person answers often or really often 4 times or more, it means that the person shows symptoms associated with ADHD.

    Measured: 2 weeks within eligibility evaluation

  9. Patient Health Questionnaire (PHQ-9)

    9-items scale with a 4-point Likert-like scale from 0 (Not at all) to 3 (Nearly every day). The total score is obtained by adding up the answer to every 9 items, ranging from 0 to 27. The score indicates the level of depression severity: 0-4 indicates none or minimal severity, 5-9 indicates a mild severity, 10-14 indicates a moderate severity, 15-19 indicates a moderately severe depression and 20-27 indicates a severe depression.

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  10. Work and social adjustment scale (WSAS)

    5-items scale with a 9 point scale from 0 (Not at all) to 8 (very severely). The total score can be obtain by adding up the score of every items. A score above 20 suggests moderately severe or worse impairment. Scores between 10 and 20 are associated with significant functional impairment. Scores below 10 appear to be associated with subclinical populations.

    Measured: 2 weeks within eligibility evaluation

  11. Perceived Improvement Questionnaire

    23-items scale with a 4 point-scale from ''Worse than before'' to ''Much better than before''. The ratings allow the participants to judge to what degree their life has improved in 23 domains since the last 3 months.

    Measured: 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  12. Client Satisfaction Questionnaire (CSQ-3)

    3-items scale. The first item can be answered with a 4-point Likert-like scale from ''None of my needs were met'' to ''Almost all of my needs were met''. The second item can be answered with a 4-point Likert-like scale from ''Really satisfied'' to ''Really unsatisfied'' and the third item can be answered with a 4-point Likert-like scale from ''No, definitely not'' to ''Yes, definitely''.

    Measured: 3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list''

  13. Scale to Assess the Therapeutic Relationship-Client (STAR-C)

    12-items scale, with three domains (positive collaboration, emotional difficulties and positive clinician input), with a 5-point Likert-like scale ranging from 0 (Never) to 4 (Always).

    Total score can range from 0 to 48. The score can be obtained by adding up the score of every item. The scores from the ''emotional difficulties'' domain must be reversed. The higher the score the better is the therapeutic relationship.

    Measured: 3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list''

  14. Perception of reaching the goal

    Participants are asked to what extent they reached their goal about their alcohol use on a scale from 0 (Not at all) to 10 (Totally).

    Measured: 3 months after first interview for the arm ''immediate treatment'' and 6 months after first interview for the group ''waiting list''

  15. Difficulties associated with the alcohol-use

    The participants are asked to what extent their alcohol use has caused them difficulties in the last 12 months, with a scale from 0 (Not at all) to 10 (Extremely).

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  16. Importance of change

    The participants are asked: to what extent is it important for you to change your alcohol use habits, with a scale from 0 (Not at all) to 10 (Extremely).

    Measured: 2 weeks within eligibility evaluation

  17. Perception of actual alcohol use

    The participants are asked: what do you currently think about your alcohol-use? with a scale from 0 (Not at all) to 10 (Extremely).

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  18. Confidence to reach the alcohol use goal

    The participants are asked: How confident are you of reaching your goals about your alcohol-use? with a scale from 0 (Not at all) to 10 (Extremely).

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

  19. High-risk situations of alcohol use assessment

    Questionnaire to assess the situations in which the person is more at risk to drink and the level of confidence to not drink in this situation. The items are measured with a 0 (Never) to 10 (Always) Likert-like scale.

    Measured: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2022
  2. Study start28 Oct 2021
  3. Primary completion14 May 2023
  4. Study completion14 May 2023

Resources

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
Model description
Participants will be randomized to either receive the treatment now (10 working days, experimental group) or in 3 months (control group).
Masking
None (open label)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05358613
Sponsor's protocol ID
CER-18-251-10.02
Status last verified
Jan 2024
First submitted
12 Apr 2022
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing My Choices in people with Alcohol Use Disorder, Mild and Alcohol Use, Unspecified, run by Université du Québec à Trois-Rivières at 5 sites in Canada.

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 3 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 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Canada. 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?

Change in self-reports of alcohol with the time-line follow-back (TLFB) in the last 90 days (time frame: 2 weeks within eligibility evaluation, 3 and 6 months after first interview (The first admission has been October 28th and the last one is anticipated June 30th)). The study lists 4 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 17 Jan 2024.

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