Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention

NCT06789250 | Recruiting

• 1 other identifier: CoMiT
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to learn if internet-based cognitive behavior therapy (ICBT ) works to treat co-occurent of problematic alcohol use and mental illness including mild to moderate symptoms of either depression, anxiety, stress or disturbed sleep. The main questions the study aims to answer are:

• Does the ICBT program lower the self-rated suffering from mental illness?
• Does the ICBT program lower the self-reported alcohol intake? Researchers will compare the ICBT program to the participants who are rancomized to a control grout that receives weekly attention from the research team, to see if the treatment works. In both groups, the participants will have the opportunity to ask for support from a therapist during the week days. Participants are adults living in Sweden. They will:
• Receive an ICBT program supported by a trained therapist. It consists of modules that the participants will work with on their computer for 10 weeks. Some modules will be compulsory and other optional for the participants.
• Fill out forms to rate their mental illness and alcohol intake at the start and the end of the study as well as once every week during treatment. Primary outcome measures are depression, anxiety and stress symptoms (measured with Depression Anxiety and Stress Scale 21 (DASS-21)) and alcohol intake measured with self-reported amounts. Other, secondary, outcome measures used will for example be about insomnia symptoms and disability assessment. Pre-treatment measurement, post-treatment measurement and 6-months and 12-months follow up is planned to be collected through an online survey.

Conditions

Alcohol Drinking Related Problems; Alcohol Use Disorders; Depressive Disorders; Mental Illness; Mental Stress; Mental and Behavioral Disorders; Sleep Problems; Stress Disorders; Anxiety Disorder/Anxiety State

Keywords

Internet intervention; Depression; Anxiety; Individually tailored; Transdiagnostic; Internet-based cognitive behavioral therapy (ICBT); Stress; Sleeping disorders; Mental illness; Harmful alcohol use; Alcohol addiction

Outcome Measures

Primary Outcomes (2)

• High-risk alcohol drinking days (HDD)

  Amount of alcohol use measured in number of high-risk drinking days (HDD), defined according to the World Health Organization (WHO) risk drinking levels, as a daily intake of ≥60 grams pure alcohol for men and ≥40 g for women. Alcohol intake is assessed by self-reported number of standard glasses of alcohol beverage (each containing 12 g of pure ethanol). This is self-reported each day with Timeline Follow Back (TLFB) procedure and then converted to grams pure alcohol.

  Change between baseline and end of treatment (expected 3 months after baseline). Additionally the change between baseline and 6 months and 12 months follow-up after end of treatment (hence expected 9 months and 15 months after baseline).

• The Depression Anxiety Stress Scales (DASS-21)

  Measure of self-reported symptoms of depression, anxiety and stress. Consists of 21 items that are scored on a range between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Scores can range between 0 and 63 points. Higher scores indicate more severe symptoms.

  Change between baseline and end of treatment (expected 3 months after baseline). Additionally the change between baseline and 6 months and 12 months follow-up after end of treatment (hence expected 9 months and 15 months after baseline).

Secondary Outcomes (10)

• Number of self-reported alcohol abstinent days

  At baseline, every 7 days during treatment, at end of treatment (expected 3 months after baseline) and 6 months and 12 months after end of treatment (expected 9 months and 15 months after baseline).

• Total amount of alcohol intake

  At baseline, every 7 days during treatment, at end of treatment (expected 3 months after baseline) and 6 months and 12 months after end of treatment (expected 9 months and 15 months after baseline).

• Alcohol craving Visual analogue scale (AC-VAS)

  At baseline, every 7 days during treatment, at end of treatment (expected 3 months after baseline) and 6 months and 12 months after end of treatment (expected 9 months and 15 months after baseline).

• Insomnia Severity Index (ISI)

  At baseline, at end of treatment (expected 3 months after baseline) and follow-up 6 months and 12 months after end of treatment (expected 9 months and 15 months after baseline).

• Perceived Stress Scale (PSS-10)

  At baseline, at end of treatment (expected 3 months after baseline) and follow-up 6 months and 12 months after end of treatment (expected 9 months and 15 months after baseline).

Study Arms (2)

Treatment group

EXPERIMENTAL

10 weeks of therapist supported, individually tailored, internet-based cognitive behavior therapy with weekly and on-demand support by a therapist.

Behavioral: Internet-based cognitive behavior therapy

Control group

NO INTERVENTION

A wait-list control condition where the participants recieve weekly attention from the research team therapists. After the treatment group has finished their 10 weeks of treatment and post-treatment measures has been collected, the control group receive the same treatment program as the treatment group.

Interventions

Internet-based cognitive behavior therapy BEHAVIORAL

The intervention within this study is based on cognitive behavioral therapy principles and adapted to target harmful alcohol use and mild to moderate alcohol use disorder co-occuring with psychological symptoms of depression, anxiety, stress and/or sleeping disorder. The 10 weeks of individually tailored treatment include psycho-educational texts as well as examples and exercises supported by a therapist.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• AUDIT ≥ 6 points for women and ≥ 8 points for men
• Symptoms of depression, anxiety disorder and/or stress-related illness
• Adequate ability to speak, read and write Swedish
• Having access to the internet and a smartphone, computer or other device.

You may not qualify if:

• Ongoing psychological treatment.
• Ongoing medication for AUD
• Severe psychiatric disorders based on a Mini-International Neuropsychiatric Interview (MINI) interview and reported medical history
• Severe medical conditions that may impede participation in the study
• Severe cognitive impairment
• Current suicidality
• Severe alcohol addiction where specialized treatment is more appropriate
• Risk for severe alcohol withdrawal symptoms with a need for medical treatment. Participation is possible after completing alcohol withdrawal treatment within the ordinary health-care system, accessible to the Swedish population.
• Substance use disorder, other than alcohol or nicotine, within the past six months.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (2)

Linköping University

Linköping, 58183, Sweden

RECRUITING

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

NOT YET RECRUITING

Related Links

• Homepage for information and registration for participation

MeSH Terms

Conditions

Alcoholism; Depressive Disorder; Mental Disorders; Stress, Psychological; Parasomnias; Stress Disorders, Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mood Disorders; Behavioral Symptoms; Behavior; Sleep Wake Disorders; Nervous System Diseases; Trauma and Stressor Related Disorders

Study Officials

• Gerhard Andersson, Professor

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerhard Andersson, Professor

CONTACT

+46(0)13285840; gerhard.andersson@liu.se

Åsa Steensland, PhD student

CONTACT

+46(0)702775777; asa.steensland@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 23, 2025
• Study Start: January 5, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

SE (2)