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
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
273 participants
INTERVENTIONAL
2018-09-04
2020-03-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Integrated Online CBT and MI
Participants in this arm will be given access to the online integrated treatment.
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.
Psychoeducation (Control)
The control group will be provided with psychoeducational resources about alcohol and mental illness.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Elevated suicidality (defined as scoring greater than "minimal risk" on a screener)
* Current psychosis or mania
18 Years
35 Years
ALL
Yes
Sponsors
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University of Manitoba
OTHER
Responsible Party
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Locations
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University of Manitoba
Winnipeg, Manitoba, Canada
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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P2017:128
Identifier Type: -
Identifier Source: org_study_id
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