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

Linköping University (LiU)

Status: Enrolling

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

Treatments: Behavioral: Internet-based cognitive behavior therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06789250

CoMiT

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Ongoing psychological treatment.
• Ongoing medication for AUD
• Recent changes (within the past three months) in psychiatric medication or planned changes during the treatment period. New medication prescribed during the study shall be reported but will not lead to exclusion
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Treatment group

Experimental group

Description:

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

Treatment:

Behavioral: Internet-based cognitive behavior therapy

Control group

No Intervention group

Description:

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.