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

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.

Interventions

• Behavioral 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.

Primary outcome measures

• High-risk alcohol drinking days (HDD) [Time frame: 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) [Time frame: 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 outcome measures (10)

• Number of self-reported alcohol abstinent days [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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).]
• The World Health Organization Disability Assessment Schedule (WHODAS-12) [Time frame: 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).]
• The Short Index of Problems (SIP) [Time frame: 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).]
• Montgomery-Åsberg Depression Rating Scale (MADRS) [Time frame: At baseline, at mid-treatment (expected 6 weeks after baseline), at end of treatment (expected 3 months after baseline) and follow-up at 6 months and 12 months after end of treatment (expected 9 months and 15 months after baseline).]
• Alcohol Use Disorder Identification Test [Time frame: 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).]
• B-Phosphatidylethanol (PEth) [Time frame: At baseline and at end of treatment (expected 3 months after baseline).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Sweden · 2 centers

• Linköping University — Linköping
• Department of Behavioral Sciences and Learning, Linköping University — Linköping

Identifiers

NCT: NCT06789250 · CoMiT

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗