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Alcohol Use DisorderNCT04611854

Internet-delivered Therapy for Alcohol Misuse: Investigating Patient Preference for Self-guided or Guided Treatment

A study testing Guidance and ICBT for alcohol misuse in people with Alcohol Use Disorder, run by University of Regina at 1 site 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

Internet-delivered cognitive behaviour therapy (ICBT) shows promise as a method of treating alcohol misuse. In this form of treatment, patients complete online lessons over several weeks that assist patients in developing skills to address alcohol misuse. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Guidance and ICBT for alcohol misuse
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCanada
Study dates
1 Nov 2020to 19 Aug 2022
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

  • Timeline Followback (TLFB; preceding week alcohol consumption) > 13 drinks
  • Alcohol Use Disorders Identification Test (AUDIT) > 7

Who cannot join

  • Suicidal ideation (measured by scoring > 2 to question 9 of PHQ-9)
  • Severe mental health or medical conditions
  • Severe drug use problems (measured by scoring > 24 on Drug Use Disorders Identification Test [DUDIT] or clinical assessment)
  • Low motivation to do, or concerns regarding, online treatment
  • Ongoing or impending significant mental health treatment
  • Not residing in Saskatchewan Canada for the duration of treatment
  • Lack of or inconsistent access to a computer and internet at home or private place for the duration of treatment

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Online Therapy Unit, University of Regina

    Regina, Saskatchewan, S4S 0A2

Other trials in Canada

About this study

Official title: Internet-delivered Therapy for Alcohol Misuse: Engagement, Outcomes and Satisfaction When Patients Select Preference for Self-guided or Guided Treatment

Internet-delivered cognitive behaviour therapy (ICBT) shows promise as a method of treating alcohol misuse. In this form of treatment, patients complete online lessons over several weeks that assist patients in developing skills to address alcohol misuse. ICBT can be offered to patients in a self-guided format or with guidance. Self-guided ICBT allows users to complete lessons by themselves without any contact with a guide. Guided ICBT involves having support from a guide in the form of emails, online messages and/or brief telephone calls. In some studies, guided-ICBT has shown greater reductions in alcohol consumption than self-guided ICBT. To date, there has been limited research on patient preferences for these varying levels of support when ICBT is offered as part of routine health care. This represents an important research direction as there is some past research showing that patients' treatment preferences can affect study enrollment, attrition, adherence, satisfaction, and outcomes.

This study will investigate patient preferences for self-guided ICBT versus guided-ICBT and compare enrollment, attrition, adherence, and outcomes of the two approaches when patients select their treatment preferences. The study will also explore the extent to which preferences are related to patient background variables (e.g., duration, severity of problems, treatment goals in terms of patients wanting to cut-down on alcohol use versus to abstain from alcohol use). Furthermore, this study seeks to identify how ratings of effort and helpfulness throughout treatment vary depending on whether patients select self-guided versus guided ICBT. This study represents a pragmatic observational trial conducted in routine care and aims to increase understanding of how to implement ICBT within routine care.

Being tested
Guidance, ICBT for alcohol misuse
Keywords
Internet-delivered Cognitive Behaviour Therapy, Guidance, Alcohol Misuse
Medical subject headings
Alcoholism

What participants receive

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

  • GuidanceBehavioural

    Guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.

  • ICBT for alcohol misuseBehavioural

    The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 8 lessons distributed across 8 weeks.

Study groups in NCT04611854
Study groupRoleWhat they receive
ICBT for alcohol misuse: GuidanceActive comparatorIn this arm, participants will receive the 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse with guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.
Receives: Behavioral: Guidance; Behavioral: ICBT for alcohol misuse
ICBT for alcohol misuse: Self-GuidanceExperimentalParticipants who select this arm will receive the 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. Participants are able to contact the Online Therapy Unit regarding any technical issues with logging onto the site. However, no guidance from a health educator will be provided. Clients will be monitored by providing brief measures on alcohol each week and measures of depression and anxiety administered at the beginning of week 5. However, clients will only be contacted if there is a significant clinical issue requiring attention (e.g., sudden increase in symptoms of depression and suicidal ideation).
Receives: Behavioral: ICBT for alcohol misuse

What is being measured

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

  1. Drinks in preceding week as measured by Timeline Followback (TLFB)

    Change in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.

    Measured: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment

  2. Heavy drinking days preceding week as measured by Timeline Followback (TLFB)

    Change in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.

    Measured: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment

Secondary outcomes (10)

  1. Alcohol Use Disorders Identification Test (AUDIT)

    Change in alcohol-related problems and behaviours measured by total AUDIT score which can range from 0 to 40. Greater score indicates greater alcohol problems (worse outcome)

    Measured: Screening, 8 weeks (post-treatment), 3 months after treatment

  2. Penn Alcohol Craving Scale

    Change in alcohol craving as measured by a total score ranging between 0 to 30. Higher scores indicate greater craving (worse outcome).

    Measured: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment

  3. Brief Situational Confidence Questionnaire (BSCQ)

    Change in confidence in resisting drinking urges in 8 situations rated from 0 to 100, rendering a sum score of 0-800. Higher scores indicate greater confidence (better outcome). There are 8 subscales, one for each item, assessed on a scale of 0-100. Thus, each subscale has a sum score of 0-100-. A higher score indicates greater confidence on the subscale.

    Measured: Screening, 8 weeks (post-treatment), 3 months after treatment

  4. Generalized Anxiety Disorder 7-item (GAD-7)

    Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome).

    Measured: Screening, 8 weeks (post-treatment), 3 months after treatment

  5. Patient Health Questionnaire (PHQ-9)

    Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome).

    Measured: Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment

  6. Sheehan Disability Scale

    Change in three scores assessing functional impairment in three domains: 1) work/school, 2) social and 3) family life (each domain score ranges from 0 to 10, rendering a sum score of 0-30). Higher score indicates greater ability on the specified domain score (better outcome). Each domain score (subscale) renders a sum score of 0-10.

    Measured: Screening, 8 weeks (post-treatment), 3 months after treatment

  7. Treatment Credibility and Expectancy Scale

    Measures the participant's thoughts and feelings about the treatment and the treatment's effectiveness in reducing participant's symptoms and increasing participant's functioning. Consists of 6 items. The first three of these and the 5th render a score of 1- 9. The other three questions render a score of 0-10. There are two subscales; 1) treatment credibility and 2) treatment expectancy. The first three questions are summed to render a score on the credibility subscale (0-27). The last three questions, the expectancy subscale, render a score of 0-29.

    Measured: 4 weeks (mid-treatment)

  8. Readiness to Change Questionnaire Treatment Version (RCQ-TV)

    Measures participants' motivation to change their drinking behaviours and determines at which stage of the Stages of Change model they are in (precontemplation, contemplation, or action). There is no sum score. Instead the items related to each stage are summed, and the individual is allocated to the stage that has the greatest score out of these three. (For more information about the scoring of this instrument, see Heather \& Hönekopp, 2009).

    Measured: Screening (Pre-treatment)

  9. Evaluation and Negative Effects Questionnaire

    This questionnaire will gather feedback from participants on perceived helpfulness and any negative effects experienced by participants during treatment. This brief questionnaire has been developed by the research team and does not have a sum score.

    Measured: 8 weeks (post-treatment)

  10. Lesson Completion

    The program website will record when patients access each lesson, providing a way to calculate the proportion of patients who complete each lesson and treatment overall.

    Measured: Ongoing throughout treatment (Weeks 1-8)

Timeline

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

  1. First posted2 Nov 2020
  2. Study start1 Nov 2020
  3. Primary completion19 Aug 2022
  4. Study completion19 Aug 2022

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
Non-randomised
Intervention model
Parallel groups
Model description
Each client will select either self-guided or guided option.
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04611854
Sponsor's protocol ID
2019-058b
Status last verified
Nov 2023
First submitted
26 Oct 2020
Last updated
4 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Other researchers may ask to review IPD from this trial following completion of data collection. For the purposes of meta-analyses or other legitimate uses, IPD will be provided after being fully de-identified.

Publications

  • Sapkota RP, Lozinski T, Wilhems A, Nugent M, Schaub MP, Keough MT, Sundstrom C, Hadjistavropoulos HD. Internet-delivered therapy for alcohol misuse: engagement, satisfaction, and outcomes when patients select their preference for therapist- or self-guided treatment. Addict Sci Clin Pract. 2024 Apr 20;19(1):30. doi: 10.1186/s13722-024-00456-8.

    PubMed 38643242

Questions about this trial

What is this clinical trial studying?

A study testing Guidance and ICBT for alcohol misuse in people with Alcohol Use Disorder, run by University of Regina at 1 site 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 2 inclusion and 7 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 4 Dec 2023. 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 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?

Drinks in preceding week as measured by Timeline Followback (TLFB) (time frame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment). The study lists 2 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 NCT04611854, which also lists 1 linked publication.

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 4 Dec 2023.

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