NCT Number: NCT06789250
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Department of Behavioral Sciences and Learning, Linköping University, Linköping, Östergötland County, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
Amount of alcohol use measured in number of high-risk drinking days (HDD), defined according to the World Health Organization (WHO) risk drinking levels, as a daily intake of ≥60 grams pure alcohol for men and ≥40 g for women. Alcohol intake is assessed by self-reported number of standard glasses of alcohol beverage (each containing 12 g of pure ethanol). This is self-reported each day with Timeline Follow Back (TLFB) procedure and then converted to grams pure alcohol.
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).
Measure of self-reported symptoms of depression, anxiety and stress. Consists of 21 items that are scored on a range between 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time). Scores can range between 0 and 63 points. Higher scores indicate more severe symptoms.
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).
Measure of number of self-reported alcohol abstinent days. Alcohol intake is assessed by self-reported number of standard glasses of alcohol beverage. This is self-reported each day with Timeline Follow Back (TLFB) procedure. A day with zero reported alcohol use is considered an abstinent day.
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).
Measure of self-reported alcohol intake. Alcohol intake is assessed by self-reported number of standard glasses of alcohol beverage (each containing 12 g of ethanol). This is self-reported each day with Timeline Follow Back (TLFB) procedure covering the last 7 days and then converted to grams of ethanol.
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).
Measure of perceived alcohol craving by self-rating on a visual analogue scale (VAS) ranging from 0 to 100 where 0 denotes no craving and 100 the worst possible craving.
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).
Measure of insomnia and sleep related-difficulties that consists of seven items. Higher self-reported scores indicate greater sleep related-difficulties. Scores can range from 0 to 28.
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).
A self-report questionnaire that measures perceived stress, sense of control and self-efficacy. It contains 10 items that are scored on a range between 0 (never) to 4 (very often). The total score range is between 0-40 and a higher score reflects higher levels of perceived stress.
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).
A self-report questionnaire that measures disability due to health conditions. It contains 12 items that are scored on a range between 0 (none) to 4 (extreme). The total score ranges between 0 to 48 and a higher score reflects a higher degree of disability.
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).
A self-report questionnaire for measuring drinking consequences in problem drinkers during the last 3 months. It contains 15 items that are scored on a range between 0 (never) to 3 (daily). The total score ranges between 0 to 45 and a higher score reflects more negative consequences from alcohol intake.
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).
A self-report questionnaire that measures symptoms of depression and detects signs of increased suicidality. It contains 9 items that are scored on a range between 0 (none) to 6 (extreme). The total score ranges between 0 to 54 and a higher score reflects more symptoms of depression.
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).
A self-report questionnaire to assess alcohol consumption, drinking behaviors, and alcohol-related problems. 10 items and scores ranging from 0-40 with higher scores indicating a higher level of problematic alcohol use.
Time frame: At baseline and at end of treatment (expected 3 months after baseline).
A biomarker of alcohol intake sampled with a measure called dried blood spot (DBS), that the participant can sample at home. Measures amount of Phosphatidylethanol (µmol/l) in blood,
Contact information is provided by the study sponsor or research team.
Gerhard Andersson, Professor
CONTACT
Åsa Steensland, PhD student
CONTACT
Linkoeping University
Other Gov
Acronym: CoMiT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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