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

NCT03406039 | Completed

• 1 other identifier: P2017:128
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol Use Disorder; Emotional Disorder; Cognitive Behavioural Therapy; Motivational Interviewing; Online Intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (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.

  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)

• Depression

  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).

• Anxiety

  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).

• Clinically Significant and Combined Reduction of Alcohol Use and Comorbid Emotional Problems

  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).

• Quality of Life

  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).

• Drug Use

  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).

Study Arms (2)

Integrated Online CBT and MI

EXPERIMENTAL

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

Behavioral: Integrated Online CBT and MI

Psychoeducation (Control)

NO INTERVENTION

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

Interventions

Integrated Online CBT and MI 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.

Integrated Online CBT and MI

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2M8, Canada

Location

Related Publications (1)

• 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.

  PMID: 30389649 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 23, 2018
• Study Start: September 4, 2018
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: March 8, 2021

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)