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Alcohol Use DisorderNCT03406039

Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems

A study testing Integrated Online CBT and MI in people with Alcohol Use Disorder, run by University of Manitoba 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

Considering the high comorbidity between alcohol use disorders and emotional problems, there is currently a need for accessible, integrated treatments designed to target both disorders simultaneously. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Alcohol Use Disorder
What is being tested?
Integrated Online CBT and MI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
1 siteCanada
Study dates
4 Sep 2018to 17 Mar 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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Individuals between 18 and 35 years old
  • Reporting at least moderate difficulties with alcohol indicated by a score >3 (for women) and <4 (for men) on the first three items of the Alcohol Use Disorders Identification Test [AUDIT], known as the AUDIT-C
  • Reporting at least moderate depression and/or anxiety symptoms indicated by a score >16 on the Center for Epidemiological Studies Depression Scale [CES-D] and/or a score of >5 on the Generalized Anxiety Disorder Scale-7 [GAD-7]
  • Fluency in English
  • Have weekly Internet access

Who cannot join

  • Self-reported engagement in other psychological or pharmacological treatments for alcohol misuse and/or depression/anxiety (with the exception of stable anti-depressants)
  • Elevated suicidality (defined as scoring greater than "minimal risk" on a screener)
  • Current psychosis or mania

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Manitoba

    Winnipeg, Manitoba, R3T 2M8

Other trials in Canada

About this study

Official title: Testing the Efficacy of an Online Self-Help Treatment for Comorbid Alcohol Misuse and Emotional Problems in Young Adult Canadians: A Randomized Controlled Trial (RCT)

Considering the high comorbidity between alcohol use disorders and emotional problems, there is currently a need for accessible, integrated treatments designed to target both disorders simultaneously. Evidence suggests that the combined use of Cognitive Behavioural Therapy (CBT) and Motivational Interviewing (MI) may be effective at reducing the combined symptoms of the two disorders. However, much of the empirical work has focused on testing the usefulness of CBT/MI for alcohol misuse and comorbid depression, and the majority of these studies involve in-person treatment. Therefore, additional empirical research is required to determine the efficacy of combined CBT and MI for alcohol use and both anxiety and depression using an online intervention. This may help inform future treatments in this domain, and potentially be able to inform the development of online, accessible interventions for this population.

Participants (N = 214) with elevated levels of alcohol use and emotional problems will be recruited from Central and Eastern Canada. Participants will be randomly assigned to either the treatment group (i.e., combined CBT and MI), or the psycho-educational control group. Individuals in the treatment group will be given 8-weeks to work through 12 online modules. Throughout the modules, participants will identify goals related to alcohol use and mood, learn strategies to cope with alcohol cravings, triggers, and social pressures, and learn how to prevent relapse. Modules will also include content designed to target anxiety and depression, focusing on strategies designed to help reduce negative thinking and worry, increase behavioural activation, and increase self-care (e.g., relaxation techniques, sleep hygiene). Participants randomly assigned to the control (i.e., psycho-education) condition will receive links to websites that provide general psychoeducation about alcohol and mental illness. All participants will complete online assessment measures at baseline, at the end of treatment, and at follow-up approximately 4 months later) in order to assess the efficacy of the treatment. At the end of the study, individuals in the control group will be given full access to the treatment.

Being tested
Integrated Online CBT and MI
Keywords
Alcohol Use Disorder, Emotional Disorder, Cognitive Behavioural Therapy, Motivational Interviewing, Online Intervention, Randomized Controlled Trial
Medical subject headings
Alcoholism

What participants receive

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

  • Integrated Online CBT and MIBehavioural

    The treatment condition will have access to 12 treatment modules and have 8-weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, young adults will identify goals related to alcohol use and mood, learn strategies to cope with alcohol cravings, triggers, and social pressures, and learn how to prevent relapse. There will also be several modules to target anxiety and depression, focusing on strategies designed to help reduce negative thinking and worry, increase behavioural activation, and increase self-care (e.g., sleep hygiene).Participants will have immediate access to all modules, and it will be recommended that they work through the modules sequentially.

Study groups in NCT03406039
Study groupRoleWhat they receive
Integrated Online CBT and MIExperimentalParticipants in this arm will be given access to the online integrated treatment.
Receives: Behavioral: Integrated Online CBT and MI
Psychoeducation (Control)No interventionThe control group will be provided with psychoeducational resources about alcohol and mental illness.

What is being measured

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

  1. Change in Alcohol Use

    Timeline Follow-Back (TLFB; Sobell \& Sobell, 1992) - designed to assess the number of standard drinks consumed during a 30-day period. Participants will be asked to report on the number of drinks consumed daily in the form of a calendar. The TLFB has been shown to provide reliable and valid estimates of alcohol use, and is widely used in basic and treatment studies.

    Measured: Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).

Secondary outcomes (6)

  1. Depression

    Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977), a 20-item self-report questionnaire used to indicate depression severity.

    Measured: Levels of depression will be assessed at all three time points. T0 - baseline (i.e., 0 days, 0 weeks, 0 months), T1 - end of treatment (i.e., 8 weeks), and T2 - follow up (i.e., 16 weeks from end of treatment).

  2. Anxiety

    Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer, Kroenke, Williams, \& Löwe, 2006), a 7-item self-report questionnaire used to measure the severity of anxiety symptoms.

    Measured: Levels of anxiety will be assessed at all three time points. T0 - baseline (i.e., 0 days, 0 weeks, 0 months), T1 - end of treatment (i.e., 8 weeks), and T2 - follow up (i.e., 16 weeks from end of treatment).

  3. Clinically Significant and Combined Reduction of Alcohol Use and Comorbid Emotional Problems

    We will also use a combined outcome to look clinically significant reductions in alcohol misuse and depression or anxiety. Specifically, a short version of the Alcohol Use Disorders Identification Test (AUDIT; Saunders et al., 1993, referred to as AUDIT-C) will be used, where falling below 4 for women and 5 for men would reflect that participants are no longer drinking hazardously. Similarly, falling below 16 on the CES-D OR 5 on the GAD-7 would reflect that participants are no longer experiencing moderate emotional symptoms. A binary outcome will be created for participants scoring below the AUDIT-C cut-off AND the cut-off for either depression OR anxiety (coded as 1) versus those scoring above cut-offs (coded as 0).

    Measured: Combined changes will be assessed at all three time points. T0 - baseline (i.e., 0 days, 0 weeks, 0 months), T1 - end of treatment (i.e., 8 weeks), and T2 - follow up (i.e., 16 weeks from end of treatment).

  4. Quality of Life

    World Health Organization Quality of Life assessment (WHOQOL-BREF; The WHOQOL Group, 1998), a 26-item self-report measure that assesses functionality in various life domains (i.e., physical and psychological health, social relationships, environment). A sum score will be used to assess overall quality of life at all assessments (T0-T2).

    Measured: Quality of life will be assessed at all three time points. T0 - baseline (i.e., 0 days, 0 weeks, 0 months), T1 - end of treatment (i.e., 8 weeks), and T2 - follow up (i.e., 16 weeks from end of treatment).

  5. Drug Use

    Participants' use of other drugs in addition to alcohol will also be included as outset continuous moderators and will be assessed using the National Institute on Drug Abuse Alcohol, Smoking, and Substance Involvement Screening Test (NIDA ASSIST; National Institute on Drug Abuse, 2009). Examples of these additional substances include cannabis, cocaine, prescription medication, methamphetamine, and opioids.

    Measured: Drug use will be assessed at all three time points. T0 - baseline (i.e., 0 days, 0 weeks, 0 months), T1 - end of treatment (i.e., 8 weeks), and T2 - follow up (i.e., 16 weeks from end of treatment).

  6. Motivation

    Participants' level of motivation will be assessed at all assessment points. Motivation for change will be assessed along three dimensions: importance, confidence, and readiness.

    Measured: Motivation will be assessed at all three time points. T0 - baseline (i.e., 0 days, 0 weeks, 0 months), T1 - end of treatment (i.e., 8 weeks), and T2 - follow up (i.e., 16 weeks from end of treatment).

Timeline

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

  1. First posted23 Jan 2018
  2. Study start4 Sep 2018
  3. Primary completion17 Mar 2020
  4. Study completion17 Mar 2020

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
A two-arm RCT will be conducted to evaluate the proposed online intervention. Eligible participants will be randomized to either the online integrated treatment condition, or the psycho-educaton (i.e., control) condition.
Masking
None (open label)
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03406039
Sponsor's protocol ID
P2017:128
Status last verified
Sep 2019
First submitted
5 Jan 2018
Last updated
8 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frohlich JR, Rapinda KK, Schaub MP, Wenger A, Baumgartner C, Johnson EA, O'Connor RM, Vincent N, Blankers M, Ebert DD, Hadjistavropoulos H, Mackenzie CS, Keough MT. Efficacy of an Online Self-Help Treatment for Comorbid Alcohol Misuse and Emotional Problems in Young Adults: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2018 Nov 1;7(11):e11298. doi: 10.2196/11298.

    PubMed 30389649

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Online CBT and MI in people with Alcohol Use Disorder, run by University of Manitoba 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 5 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 8 Mar 2021. 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?

Change in Alcohol Use (time frame: Participants will be assessed using the TLFB at three time points: at baseline (i.e., prior to treatment; T0), immediately following the 8-week treatment (T1), and at follow-up (i.e., 24 weeks from baseline, 16 weeks from end of treatment, T2).). 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 NCT03406039, 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 8 Mar 2021.

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