Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention
NCT ID: NCT06789250
Last Updated: 2025-02-24
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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RECRUITING
NA
240 participants
INTERVENTIONAL
2025-01-05
2026-05-31
Brief Summary
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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.
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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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Treatment group
10 weeks of therapist supported, individually tailored, internet-based cognitive behavior therapy with weekly and on-demand support by a therapist.
Internet-based cognitive behavior therapy
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.
Control group
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.
No interventions assigned to this group
Interventions
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Internet-based cognitive behavior therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Linkoeping University
OTHER_GOV
Responsible Party
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Gerhard Andersson
Professor
Principal Investigators
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Gerhard Andersson, Professor
Role: PRINCIPAL_INVESTIGATOR
Linkoeping University
Locations
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Linköping University
Linköping, , Sweden
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, Sweden
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Homepage for information and registration for participation
Other Identifiers
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CoMiT
Identifier Type: -
Identifier Source: org_study_id
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