Alcohol AbuseFoBeMANCT02014779
Internet-Based Relapse Prevention vs Face to Face Therapy at an Employee Assistance Program
A study testing eChange and Face-to-face therapy in people with Alcohol Abuse and Alcohol Addiction, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Objectives: This study will evaluate the efficacy of internet-based relapse prevention with therapist support, as compared to face-to-face therapy at an employee assistance program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Abuse, Alcohol Addiction
- What is being tested?
- eChange and Face-to-face therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Mar 2016
- 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
- Problematic alcohol use and having been recommended psychotherapy by the assessing psychologist.
Who cannot join
- Inadequate Swedish language skills No Internet access Reading and/or writing difficulties Major depression Current suicidal thoughts and/or plans Primary problematic drug use PTSD-related problems Psychosis Cognitive disability
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska institutet, Department of Clinical Neuroscience
Stockholm, 171 76
About this study
Official title: Internet-Based Relapse Prevention With Therapist Support vs Face to Face Therapy at an Employee Assistance Program: A Randomized Controlled Non-inferiority Trial
Objectives: This study will evaluate the efficacy of internet-based relapse prevention with therapist support, as compared to face-to-face therapy at an employee assistance program. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use, as well as depression and quality of life.
Method: Participants with problematic alcohol use who, after an initial evaluation consisting of five face-to-face sessions with a licensed psychologist where alcohol and collateral problems are extensively assessed, are recommended treatment for problematic alcohol use. Consenting participants will be randomized into one of two groups: 1. Internet delivered relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on alcohol use, depression and quality of life as well as information on user satisfaction will be gathered post treatment. Follow up will be at 3, 6 and 12 months after completion.
Our hypothesis is that the internet-based program with therapist support and the face-to-face therapy will be equally effective in reducing alcohol use (non-inferiority).
- Conditions
- Alcohol Abuse, Alcohol Addiction
- Being tested
- eChange, Face-to-face therapy
- Keywords
- Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eChangeBehavioural
A web-based relapse intervention program consisting of 14 modules. The patient will have access to therapist support through a secure messaging system
Face-to-face therapyBehavioural
Face-to-face psychotherapy, consisting of 20 sessions. The content will be different for different therapists, but all have an evidence based approach to therapy
| Study group | Role | What they receive |
|---|---|---|
| eChange web-based relapse prevention | Experimental | A relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system. Receives: Behavioral: eChange |
| Face-to-face therapy | Active comparator | Face-to-face psychotherapy, consisting of 20 sessions. The content will be vary for different therapists, but all have an evidence-based approach to therapy Receives: Behavioral: Face-to-face therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Identification Test (AUDIT)
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
Measured: Post, 3, 6 and 12 months
Secondary outcomes (3)
Time Line Follow Back (TLFB)
Change in total TLFB score, as a summarized measure of alcohol consumption
Measured: Post, 3, 6 and 12 months
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
Change in total MADRS-S score, as a summarized measure of depression
Measured: Post, 3, 6 and 12 months
World Health Quality of Life Scale (WHOQOL-BREF)
Change in total WHOQOL-BREF score, as a summarized measure of quality of life
Measured: Post, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Only 1 participant recruited to study. Qs addressed in other ongoing studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol AbuseStudies 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
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- 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
- NCT02014779
- Sponsor's protocol ID
- 2013/1391-31/5
- Acronym
- FoBeMA
- Status last verified
- Mar 2016
- First submitted
- 12 Dec 2013
- Last updated
- 15 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Relapse Prevention With Therapist Support vs Face to Face Therapy at an Employee Assistance Program: A Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT02014779
- Acronym / sponsor ID
- FoBeMA / 2013/1391-31/5
- Conditions
- Alcohol Abuse, Alcohol Addiction
- Keywords
- Randomized Controlled Trial, Alcohol, Internet, Internet based therapy, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only 1 participant recruited to study. Qs addressed in other ongoing studies.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Dec 2013 (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.
Objectives: This study will evaluate the efficacy of internet-based relapse prevention with therapist support, as compared to face-to-face therapy at an employee assistance program. The design is a two-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use, as well as depression and quality of life.
Method: Participants with problematic alcohol use who, after an initial evaluation consisting of five face-to-face sessions with a licensed psychologist where alcohol and collateral problems are extensively assessed, are recommended treatment for problematic alcohol use. Consenting participants will be randomized into one of two groups: 1. Internet delivered relapse prevention with therapist support or 2. Face-to-face therapy. Outcomes on alcohol use, depression and quality of life as well as information on user satisfaction will be gathered post treatment. Follow up will be at 3, 6 and 12 months after completion.
Our hypothesis is that the internet-based program with therapist support and the face-to-face therapy will be equally effective in reducing alcohol use (non-inferiority).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eChange web-based relapse prevention | Experimental | Behavioral: eChangeA relapse intervention program consisting of 14 modules. Patients will have access to therapist support through an internal secure messaging system. |
| Face-to-face therapy | Active comparator | Behavioral: Face-to-face therapyFace-to-face psychotherapy, consisting of 20 sessions. The content will be vary for different therapists, but all have an evidence-based approach to therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Problematic alcohol use and having been recommended psychotherapy by the assessing psychologist.
Key exclusion criteria (1 listed)
- Inadequate Swedish language skills No Internet access Reading and/or writing difficulties Major depression Current suicidal thoughts and/or plans Primary problematic drug use PTSD-related problems Psychosis Cognitive disability
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 |
|---|---|---|
| eChangeA web-based relapse intervention program consisting of 14 modules. The patient will have access to therapist support through a secure messaging system | Behavioural | eChange web-based relapse prevention |
| Face-to-face therapyFace-to-face psychotherapy, consisting of 20 sessions. The content will be different for different therapists, but all have an evidence based approach to therapy | Behavioural | Face-to-face therapy |
Primary outcome
Alcohol Use Identification Test (AUDIT)
Time frame: Post, 3, 6 and 12 months
Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems)
3 secondary outcomes
Time Line Follow Back (TLFB)
Time frame: Post, 3, 6 and 12 months
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)
Time frame: Post, 3, 6 and 12 months
World Health Quality of Life Scale (WHOQOL-BREF)
Time frame: Post, 3, 6 and 12 months
Results and safety
The study was stopped early (reason given: Only 1 participant recruited to study. Qs addressed in other ongoing studies.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2016.
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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 eChange and Face-to-face therapy in people with Alcohol Abuse and Alcohol Addiction, 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Mar 2016. 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 was stopped early (reason given: Only 1 participant recruited to study. Qs addressed in other ongoing studies.). Results are not available in the source record.
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?
Alcohol Use Identification Test (AUDIT) (time frame: Post, 3, 6 and 12 months). 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 15 Mar 2016.