Alcohol Drinking Related ProblemsCoMiTNCT06789250
Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention
A study testing Internet-based cognitive behavior therapy in people with Alcohol Drinking Related Problems and Alcohol Use Disorders, run by Linkoeping University at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Drinking Related Problems, Alcohol Use Disorders, Depressive Disorders
- What is being tested?
- Internet-based cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesSweden
- Study dates
- 5 Jan 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Linköping University
Linköping, 58183
Gerhard Andersson, Professor, +4613285840, gerhard.andersson@liu.se
Åsa Steensland, PhD Student, +46(0)702775777, asa.steensland@liu.se
- Not yet recruiting
Department of Behavioral Sciences and Learning, Linköping University
Linköping, Östergötland County, 58183
Gerhard Andersson, Professor, +4613285840, gerhard.andersson@liu.se
Åsa Steensland, PhD Student, +46(0)702775777, asa.steensland@liu.se
About this study
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:
Read more
- 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.
- Conditions
- Alcohol Drinking Related Problems, Alcohol Use Disorders, Depressive Disorders, Mental Illness, Mental Stress, Mental and Behavioral Disorders
- Being tested
- Internet-based cognitive behavior therapy
- Keywords
- Internet intervention, Depression, Anxiety, Individually tailored, Transdiagnostic, Internet-based cognitive behavioral therapy (ICBT), Stress, Sleeping disorders, Mental illness, Harmful alcohol use, Alcohol addiction
- Medical subject headings
- Alcoholism, Depressive Disorder, Mental Disorders, Stress, Psychological, Parasomnias, Stress Disorders, Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavior therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 10 weeks of therapist supported, individually tailored, internet-based cognitive behavior therapy with weekly and on-demand support by a therapist. Receives: Behavioral: Internet-based cognitive behavior therapy |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-risk alcohol drinking days (HDD)
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.
Measured: 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)
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.
Measured: 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 outcomes (10)
Number of self-reported alcohol abstinent days
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
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.
Measured: 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)
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,
Measured: At baseline and at end of treatment (expected 3 months after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start5 Jan 2025
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Drinking Related ProblemsStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gerhard Andersson, Linkoeping University
- Investigators
- Gerhard Andersson, Professor, Principal investigator, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789250
- Sponsor's protocol ID
- CoMiT
- Acronym
- CoMiT
- Status last verified
- Feb 2025
- First submitted
- 18 Dec 2024
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-occurence of Mental Illness and Problematic Alcohol Use: an Internet-based Cognitive Behavior Therapy Intervention
- ClinicalTrials.gov ID
- NCT06789250
- Acronym / sponsor ID
- CoMiT / CoMiT
- Conditions
- Alcohol Drinking Related Problems, Alcohol Use Disorders, Depressive Disorders, Mental Illness, Mental Stress, Mental and Behavioral Disorders
- Keywords
- Internet intervention, Depression, Anxiety, Individually tailored, Transdiagnostic, Internet-based cognitive behavioral therapy (ICBT), Stress, Sleeping disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Internet-based cognitive behavior therapy10 weeks of therapist supported, individually tailored, internet-based cognitive behavior therapy with weekly and on-demand support by a therapist. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive behavior therapyThe 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. | Behavioural | Treatment group |
Primary outcome
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).
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.
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).
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.
10 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Homepage for information and registration for participationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gerhard Andersson, Professor principal investigator
Linkoeping University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavior therapy in people with Alcohol Drinking Related Problems and Alcohol Use Disorders, run by Linkoeping University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Andersson, Professor (+46(0)13285840, gerhard.andersson@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.