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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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.

Study details

Alcohol Drinking Related Problems, Alcohol Use Disorders, Depressive Disorders, Mental Illness, Mental Stress

NCT06789250

Linkoeping University

28 March 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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