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

NCT ID: NCT03406039

Last Updated: 2021-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2020-03-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alcohol Use Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Integrated Online CBT and MI

Participants in this arm will be given access to the online integrated treatment.

Group Type EXPERIMENTAL

Integrated Online CBT and MI

Intervention Type BEHAVIORAL

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.

Psychoeducation (Control)

The control group will be provided with psychoeducational resources about alcohol and mental illness.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Integrated Online CBT and MI

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30389649 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P2017:128

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Couples Therapy for Alcoholic Patients
NCT01659957 COMPLETED PHASE2
The UniVenture Program
NCT05383989 UNKNOWN NA