Alcohol Use DisordersICBT-AUDNCT02645721
Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders
A study testing Extended self-help program with guidance, Briefer Self-help program, no guidance and WL: Extended self-help program, choice of guidance intensity in people with Alcohol Use Disorders, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorders
- What is being tested?
- Extended self-help program with guidance, Briefer Self-help program, no guidance and WL: Extended self-help program, choice of guidance intensity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ≥ 18 years
- access to the internet
- consumption of at least 9 (females)/14 (males) glasses of alcohol during the preceding week
- AUDIT ≥ 14 for females, ≥ 16 for men
- have an Alcohol Use Disorder according to the DSM-5 (i.e., at least 2 out of 11 criteria)
Who cannot join
- insufficient Swedish skills
- reading or writing difficulties, if it is to a degree that it will hamper the treatment
- concurrent other psychological treatment with a content resembling treatments in this study
- severe depression defined as a score of more than 30 on the MADRS-S
- suicide-risk defined as more than 4 points on the MADRS-S question 9, or based on the structured interview
- Drug use problems defined as ≥ 8 p on the DUDIT
- somatic or psychiatric disorders that are contraindicated for the treatment or impairs the ability to receive it (for example schizophrenia, bipolar disease, PTSD)
- has during the last 3 weeks begun medication for alcohol problems or other psychiatric disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial
The purpose of this study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance.
Read the detailed description
Two Internet based programs based on cognitive behavioral therapy and relapse prevention are evaluated among Internet help seekers, and compared to a waiting list. The design is a three armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption (mean consumption/week, number of heavy drinking days/week), problematic alcohol use, self efficacy, craving, as well as depression, anxiety and quality of life. In addition to this, the following instruments will be used as predictors: ASRS (ADHD), Hp5i (personality assessment). TIC-P, an instrument measuring cost effectiveness will also be used. Treatment Credibility and Adverse Events will also be assessed, the former once during the third week of treatment, and the latter once half way through treatment and once after treatment.
Primary hypothesis is that the more extended program with guidance (group 1) is more effective in reducing mean alcohol consumption and number of heavy drinking days compared to the briefer program with no guidance (group 2), as well as compared to a waiting list (group 3). A responder to treatment is defined as a participant drinking less than 9 (women)/ 14(men) glasses per week and no more than 3 (women)/4 (men) glasses per drinking day during that week.
A minimum of 169 participants will be recruited in two phases: first through an online screening and then through a diagnostic telephone assessment, where SCID will be used to diagnose Alcohol Use Disorders and MINI will be used to diagnose other psychiatric diagnoses. The telephone assessment and all guidance will be conducted by licensed psychologists or master students in psychology under supervision by licensed psychologists.
Included participants will be randomized into three groups:
Group 1: All participants in this group will have access to an extended cognitive behavioral treatment program and have access to a guide with basic training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
Group 2: Participants in this group will have access to a briefer cognitive behavior treatment program with no access to a guide.
Group 3: Participants in this group will be placed on a waiting list for 12 weeks. Thereafter, they will be given access to the same extended cognitive behavior treatment program as Group 1; they will also be offered a possibility to choose between three guidance options: Choice 1: guide with intensive support, Choice 2: guide with support only at request, Choice 3: no guide.
Interim analyses will be undertaken in May 2016 by graduate students in Clinical psychology writing their MSc theses.
- Conditions
- Alcohol Use Disorders
- Being tested
- Extended self-help program with guidance, Briefer Self-help program, no guidance, WL: Extended self-help program, choice of guidance intensity
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extended self-help program with guidanceBehavioural
Also called ePlus with guidance
See arm description for Experimental
Briefer Self-help program, no guidanceBehavioural
Also called eChange
See arm description for Active Comparator
WL: Extended self-help program, choice of guidance intensityBehavioural
Also called ePlus with choice of guidance intensity
See arm description for Waiting list.
| Study group | Role | What they receive |
|---|---|---|
| Extended self-help program with guidance | Experimental | The program is a comprehensive CBT program lasting 12 weeks, with as many modules. The modules are quite extensive. A guide with basic education in psychotherapy assists and counsels participants online. Receives: Behavioral: Extended self-help program with guidance |
| Briefer Self-help program, no guidance | Active comparator | This self-help program also lasts 12 weeks but contains only 9 modules; a pause occurs during the final weeks of the program for self-testing of acquired skills. The modules are quite brief. Participants receive no guidance. Receives: Behavioral: Briefer Self-help program, no guidance |
| WL: Extended self-help program, choice of guidance intensity | Other | Participants will be put on a waiting list. After 12 weeks on the waiting list, participants will receive access the the extended self-help program used in the experimental arm. However, participants will be offered a choice between three guidance options of varying intensity: proactive guidance, reactive guidance (only at participant request) or no guidance. Receives: Behavioral: WL: Extended self-help program, choice of guidance intensity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back
Number of standard drinks during preceding week (using the Time Line Follow Back)
Measured: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Time Line Follow Back
Days of heavy drinking during preceding week (using the Time Line Follow Back)
Measured: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Secondary outcomes (13)
Alcohol Use Disorders Identification Test
assessement of alcohol use problems
Measured: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Alcohol Abstinence Self Efficacy Scale
instrument measuring self-efficacy
Measured: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Penn Alcohol Craving Scale
instrument measuring craving for alcohol
Measured: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Montgomery Asberg Depression Rating Scale
instrument measuring depression
Measured: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Euro-QOL 5 D
instrument measuring quality of life
Measured: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Generalized Anxiety Disorder-7
instrument measuring anxiety
Measured: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P)
Instrument measuring health care consumption and cost-effectiveness (Bouwmans et al., 2013
Measured: Screening, 12 months, 24 months post-treatment
Self-report questionnnaire on satisfaction with internet treatment usability features
This instrument contains 40 questions about satisfaction with various features of the internet-based treatment. Results will be analyzed on an aggregated group level. The questionnaire was constructed by the Internet psychiatry clinic in Stockholm.
Measured: Post-treatment (12 weeks after before-treatment measure)
Adult ADHD Self Report Scale (ASRS)
Screening of ADHD symptoms to be used as predictor of treatment outcome
Measured: Screening
Health-relevant Personality traits from a Five-factor perspective (hp5i)
Screening of personality traits to be used as predictor of treatment outcome
Measured: Screening
Adverse Events
Brief questionnaire with questions about any negative side effects of the treatment
Measured: Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure)
Treatment Credibility Scale
Brief questionnaire about if the treatment this far is perceived as effective
Measured: 3 weeks after before-treatment measure
SCID- section of Alcohol Use Disorders (adjusted to DSM5)
Diagnostic interview via telephone, diagnostic criteria of Alcohol Use Disorders (this will be undertaken if resurces allow). This will be a masked assessment, the interviewer will not know which original group the participant was randomized to
Measured: Screening interview, 12 and 24 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Göteborg University
- Responsible party
- Principal investigator, Anne H Berman, Karolinska Institutet
- Investigators
- Anne H Berman, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645721
- Sponsor's protocol ID
- 2015/2014-31
- Acronym
- ICBT-AUD
- Status last verified
- Jun 2020
- First submitted
- 2 Jan 2016
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Based Cognitive Behavior Treatment for Alcohol Use Disorders - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02645721
- Acronym / sponsor ID
- ICBT-AUD / 2015/2014-31
- Conditions
- Alcohol Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Jan 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 5 Jan 2016 (estimated)
- 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 purpose of this study is to determine whether extensive internet based cognitive behavior treatment program with guidance is a more effective method to treat individuals with alcohol use disorders than a briefer cognitive behavior treatment program without guidance.
Detailed description
Two Internet based programs based on cognitive behavioral therapy and relapse prevention are evaluated among Internet help seekers, and compared to a waiting list. The design is a three armed randomized controlled trial, and outcomes are measured in terms of changes in alcohol consumption (mean consumption/week, number of heavy drinking days/week), problematic alcohol use, self efficacy, craving, as well as depression, anxiety and quality of life. In addition to this, the following instruments will be used as predictors: ASRS (ADHD), Hp5i (personality assessment). TIC-P, an instrument measuring cost effectiveness will also be used. Treatment Credibility and Adverse Events will also be assessed, the former once during the third week of treatment, and the latter once half way through treatment and once after treatment.
Primary hypothesis is that the more extended program with guidance (group 1) is more effective in reducing mean alcohol consumption and number of heavy drinking days compared to the briefer program with no guidance (group 2), as well as compared to a waiting list (group 3). A responder to treatment is defined as a participant drinking less than 9 (women)/ 14(men) glasses per week and no more than 3 (women)/4 (men) glasses per drinking day during that week.
A minimum of 169 participants will be recruited in two phases: first through an online screening and then through a diagnostic telephone assessment, where SCID will be used to diagnose Alcohol Use Disorders and MINI will be used to diagnose other psychiatric diagnoses. The telephone assessment and all guidance will be conducted by licensed psychologists or master students in psychology under supervision by licensed psychologists.
Included participants will be randomized into three groups:
Group 1: All participants in this group will have access to an extended cognitive behavioral treatment program and have access to a guide with basic training in psychotherapy (CBT) who assists and counsels the participant throughout the program.
Group 2: Participants in this group will have access to a briefer cognitive behavior treatment program with no access to a guide.
Group 3: Participants in this group will be placed on a waiting list for 12 weeks. Thereafter, they will be given access to the same extended cognitive behavior treatment program as Group 1; they will also be offered a possibility to choose between three guidance options: Choice 1: guide with intensive support, Choice 2: guide with support only at request, Choice 3: no guide.
Interim analyses will be undertaken in May 2016 by graduate students in Clinical psychology writing their MSc theses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Extended self-help program with guidance | Experimental | Behavioral: Extended self-help program with guidanceThe program is a comprehensive CBT program lasting 12 weeks, with as many modules. The modules are quite extensive. A guide with basic education in psychotherapy assists and counsels participants online. |
| Briefer Self-help program, no guidance | Active comparator | Behavioral: Briefer Self-help program, no guidanceThis self-help program also lasts 12 weeks but contains only 9 modules; a pause occurs during the final weeks of the program for self-testing of acquired skills. The modules are quite brief. Participants receive no guidance. |
| WL: Extended self-help program, choice of guidance intensity | Other | Behavioral: WL: Extended self-help program, choice of guidance intensityParticipants will be put on a waiting list. After 12 weeks on the waiting list, participants will receive access the the extended self-help program used in the experimental arm. However, participants will be offered a choice between three guidance options of varying intensity: proactive guidance, reactive guidance (only at participant request) or no guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years
- access to the internet
- consumption of at least 9 (females)/14 (males) glasses of alcohol during the preceding week
- AUDIT ≥ 14 for females, ≥ 16 for men
- have an Alcohol Use Disorder according to the DSM-5 (i.e., at least 2 out of 11 criteria)
Key exclusion criteria (8 listed)
- insufficient Swedish skills
- reading or writing difficulties, if it is to a degree that it will hamper the treatment
- concurrent other psychological treatment with a content resembling treatments in this study
- severe depression defined as a score of more than 30 on the MADRS-S
- suicide-risk defined as more than 4 points on the MADRS-S question 9, or based on the structured interview
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 |
|---|---|---|
| Extended self-help program with guidanceAlso: ePlus with guidanceSee arm description for Experimental | Behavioural | Extended self-help program with guidance |
| Briefer Self-help program, no guidanceAlso: eChangeSee arm description for Active Comparator | Behavioural | Briefer Self-help program, no guidance |
| WL: Extended self-help program, choice of guidance intensityAlso: ePlus with choice of guidance intensitySee arm description for Waiting list. | Behavioural | WL: Extended self-help program, choice of guidance intensity |
Primary outcome
Time Line Follow Back
Time frame: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Number of standard drinks during preceding week (using the Time Line Follow Back)
Time Line Follow Back
Time frame: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment
Days of heavy drinking during preceding week (using the Time Line Follow Back)
13 secondary outcomes
Alcohol Use Disorders Identification Test
Time frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Alcohol Abstinence Self Efficacy Scale
Time frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Penn Alcohol Craving Scale
Time frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Montgomery Asberg Depression Rating Scale
Time frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Euro-QOL 5 D
Time frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Generalized Anxiety Disorder-7
Time frame: Screening, Post-treatment (12 weeks), 3-, 12-, and 24-months post-treatment
Trimbos and iMTA questionnaire on cCosts associated with Psychiatric illness (TiC-P)
Time frame: Screening, 12 months, 24 months post-treatment
Self-report questionnnaire on satisfaction with internet treatment usability features
Time frame: Post-treatment (12 weeks after before-treatment measure)
Adult ADHD Self Report Scale (ASRS)
Time frame: Screening
Health-relevant Personality traits from a Five-factor perspective (hp5i)
Time frame: Screening
Adverse Events
Time frame: Halfway through treatment (6 weeks after before-treatment measure) and post-treatment (12 weeks after before-treatment measure)
Treatment Credibility Scale
Time frame: 3 weeks after before-treatment measure
SCID- section of Alcohol Use Disorders (adjusted to DSM5)
Time frame: Screening interview, 12 and 24 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Anne H Berman, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extended self-help program with guidance, Briefer Self-help program, no guidance and WL: Extended self-help program, choice of guidance intensity in people with Alcohol Use Disorders, run by Karolinska Institutet at 1 site 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 8 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: finished, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Line Follow Back (time frame: Screening; Changes before treatment, Post-treatment (12 weeks); and changes after 3-, 12-, and 24-months post-treatment). 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 25 Jun 2020.