NCT06789250 Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention
| NCT ID | NCT06789250 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Linkoeping University |
| Condition | Alcohol Drinking Related Problems |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2025-01-05 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 240 participants in total. It began in 2025-01-05 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Gerhard Andersson, Professor
PRINCIPAL INVESTIGATOR
Linkoeping University
Frequently Asked Questions
Who can join the NCT06789250 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alcohol Drinking Related Problems. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06789250 currently recruiting?
Yes, NCT06789250 is actively recruiting participants. Contact the research team at gerhard.andersson@liu.se for enrollment information.
Where is the NCT06789250 trial being conducted?
This trial is being conducted at Linköping, Sweden, Linköping, Sweden.
Who is sponsoring the NCT06789250 clinical trial?
NCT06789250 is sponsored by Linkoeping University. The principal investigator is Gerhard Andersson, Professor at Linkoeping University. The trial plans to enroll 240 participants.