Alcohol Use DisordersICBT-APNCT02384278
Internet Based Cognitive Behavior Treatment for Alcohol Problems
A study testing Internet-based CBT for alcohol problems 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 internet based cognitive behavior therapy might be effective in the treatment of alcohol problems. 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?
- Internet-based CBT for alcohol problems
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2015to Jul 2017
- 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
- problematic alcohol use defined as ≥ 16 p or more for men and ≥ 14 p or more for women in the Alcohol Use Identification Scale
Who cannot join
- not adequately fluent in Swedish
- reading or writing impairment if this is so severe as to affect treatment
- ongoing psychological treatment with content similar to the treatment being studied
- suicide risk defined as ≥ 4 p på MADRS-S Q 9 or through a telephone interview with clinician
- severe depression defined as MADRS-S ≥ 30 p
- somatic or psychiatric conditions that are contraindicated for the treatment such as psychosis, bipolar disorder (depressive or manic phase), severe post traumatic stress disorder.
- has during the last 3 weeks begun using medication for alcohol problems or other psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
Stockholm, 11364
About this study
Official title: Internet Based Cognitive Behavior Treatment for Alcohol Problems: A Pilot Study
The purpose of this study is to determine whether internet based cognitive behavior therapy might be effective in the treatment of alcohol problems.
Read the detailed description
A 12 week Internet based self help program based on cognitive behavioral therapy and relapse prevention is tested among Internet help seekers as well as among patients seeking help in addiction care.The design is a one armed pilot study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, self efficacy, craving, as well as depression and quality of life. 20 participants are recruited entirely online from an open access website and 20 participants are recruited through information given to them at an addiction clinic. All participants have access to the same self help program and have access to a licensed psychologist who guides the person all the way through the program.
- Conditions
- Alcohol Use Disorders
- Being tested
- Internet-based CBT for alcohol problems
- Keywords
- alcohol use disorder, internet, cognitive behavior therapy, relapse prevention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based CBT for alcohol problemsBehavioural
A 12-week internet-based program based on cognitive behavior treatment (CBT) and relapse prevention
| Study group | Role | What they receive |
|---|---|---|
| Internet-based CBT for alcohol problems | Experimental | A 12-week internet-based cognitive behavior treatment (CBT) and relapse prevention program. The subjects will have access to a psychologist guiding them through the program. Receives: Behavioral: Internet-based CBT for alcohol problems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Line Follow Back (TLFB)
Change in total TLFB score (consumption during preceding week), as a summarized
Measured: Baseline, 14 and 26 weeks
Secondary outcomes (7)
Alcohol Use Disorders Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
Measured: Baseline, 14 and 26 weeks
Drug Use Identification Test (DUDIT)
Change in total DUDIT score, as a summarized measure of drug use (including drug consumption and drug-related problems)
Measured: Baseline, 14 and 26 weeks
Montgomery Asberg Depression Rating Scale - self report (MADRS-S)
Change in total MADRS-S score, as a summarized measure of depression
Measured: Baseline, 14 and 26 weeks
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Change in total WHOQOL-BREF score, as a summarized measure of quality of life
Measured: Baseline, 14 and 26 weeks
Alcohol Abstinence Self Efficacy Scale (AASES)
Change in total AASES score, as a summarized measure of self efficacy
Measured: Baseline, 14 and 26 weeks
Penn Alcohol Craving Scale (PACS)
Measured: Baseline, 14 and 26 weeks
Readiness to Change Questionnaire (RTCQ)
Score in RTCQ as a summarized measure of motivation used as predictor for other outcomes
Measured: Baseline, 14 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 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
- NCT02384278
- Sponsor's protocol ID
- ID10
- Acronym
- ICBT-AP
- Status last verified
- Aug 2019
- First submitted
- 26 Feb 2015
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The dataset, unidentified, with background characteristics and outcomes is available as below.
Publications
Sundstrom C, Kraepelien M, Eek N, Fahlke C, Kaldo V, Berman AH. High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorder: a pilot study. BMC Psychiatry. 2017 May 26;17(1):197. doi: 10.1186/s12888-017-1355-6.
PubMed 28549424
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Based Cognitive Behavior Treatment for Alcohol Problems: A Pilot Study
- ClinicalTrials.gov ID
- NCT02384278
- Acronym / sponsor ID
- ICBT-AP / ID10
- Conditions
- Alcohol Use Disorders
- Keywords
- alcohol use disorder, internet, cognitive behavior therapy, relapse prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Göteborg University
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 Mar 2015 (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 internet based cognitive behavior therapy might be effective in the treatment of alcohol problems.
Detailed description
A 12 week Internet based self help program based on cognitive behavioral therapy and relapse prevention is tested among Internet help seekers as well as among patients seeking help in addiction care.The design is a one armed pilot study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, self efficacy, craving, as well as depression and quality of life. 20 participants are recruited entirely online from an open access website and 20 participants are recruited through information given to them at an addiction clinic. All participants have access to the same self help program and have access to a licensed psychologist who guides the person all the way through the program.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-based CBT for alcohol problems | Experimental | Behavioral: Internet-based CBT for alcohol problemsA 12-week internet-based cognitive behavior treatment (CBT) and relapse prevention program. The subjects will have access to a psychologist guiding them through the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years
- access to the Internet
- problematic alcohol use defined as ≥ 16 p or more for men and ≥ 14 p or more for women in the Alcohol Use Identification Scale
Key exclusion criteria (7 listed)
- not adequately fluent in Swedish
- reading or writing impairment if this is so severe as to affect treatment
- ongoing psychological treatment with content similar to the treatment being studied
- suicide risk defined as ≥ 4 p på MADRS-S Q 9 or through a telephone interview with clinician
- severe depression defined as MADRS-S ≥ 30 p
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 CBT for alcohol problemsA 12-week internet-based program based on cognitive behavior treatment (CBT) and relapse prevention | Behavioural | Internet-based CBT for alcohol problems |
Primary outcome
Time Line Follow Back (TLFB)
Time frame: Baseline, 14 and 26 weeks
Change in total TLFB score (consumption during preceding week), as a summarized
7 secondary outcomes
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Baseline, 14 and 26 weeks
Drug Use Identification Test (DUDIT)
Time frame: Baseline, 14 and 26 weeks
Montgomery Asberg Depression Rating Scale - self report (MADRS-S)
Time frame: Baseline, 14 and 26 weeks
World Health Organization Quality of Life Scale (WHOQOL-BREF)
Time frame: Baseline, 14 and 26 weeks
Alcohol Abstinence Self Efficacy Scale (AASES)
Time frame: Baseline, 14 and 26 weeks
Penn Alcohol Craving Scale (PACS)
Time frame: Baseline, 14 and 26 weeks
Readiness to Change Questionnaire (RTCQ)
Time frame: Baseline, 14 and 26 weeks
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 14 Aug 2019.
- Derived from this study: PubMed 28549424Sundstrom C, Kraepelien M, Eek N, Fahlke C, Kaldo V, Berman AH. High-intensity therapist-guided internet-based cognitive behavior therapy for alcohol use disorder: a pilot study. BMC Psychiatry. 2017 May 26;17(1):197. doi: 10.1186/s12888-017-1355-6.
- Individual participant dataSharing planned: Yes. The dataset, unidentified, with background characteristics and outcomes is available as below.
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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 Internet-based CBT for alcohol problems 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 3 inclusion and 7 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 14 Aug 2019. 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 (TLFB) (time frame: Baseline, 14 and 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02384278, which also lists 1 linked publication.
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 14 Aug 2019; AzTrials last refreshed its copy on 26 Oct 2026.