Alcohol AbuseNCT02384304
Guided and Unguided Internet Treatment for Problematic Alcohol Use
A study testing Choice, Messages and Self help in people with Alcohol Abuse and Alcohol Addiction, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects. 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?
- Choice, Messages and Self help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2012to Mar 2013
- 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 ≥ 8 p or more for men and ≥ 6 p or more for women in the Alcohol Use Identification Scale
Who cannot join
- not adequately fluent in Swedish
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska institutet, Department of Clinical Neuroscience, Center for Psychiatric Research
Stockholm, Stockholm County, 11364
About this study
Official title: Guided and Unguided Internet Treatment for Problematic Alcohol Use: A Randomized Pilot Study
The purpose of this study was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.
Read the detailed description
Objectives: An 10 week Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help seekers.The design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life. 80 participants were recruited entirely online from an open access website and randomized into three different groups. All participants had access to the same self-help program. However, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.
- Conditions
- Alcohol Abuse, Alcohol Addiction
- Being tested
- Choice, Messages, Self help
- Keywords
- randomized controlled trial, alcohol, internet, internet based therapy, cognitive behavior therapy
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChoiceBehavioural
A self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions
MessagesBehavioural
A self help program consisting of 8 modules and access to therapist guidance through messages
Self helpBehavioural
A self help program consisting of 8 modules
| Study group | Role | What they receive |
|---|---|---|
| Choice | Experimental | A self help program consisting of 8 modules. Patients will have access to therapist support through either messages or chat sessions Receives: Behavioral: Choice |
| Messages | Experimental | A self help program consisting of 8 modules. Patients will have access to therapist support through messages Receives: Behavioral: Messages |
| Self help | Active comparator | A relapse intervention program consisting of 8 modules. Patients will have no access to therapist support Receives: Behavioral: Self help |
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 measure of alcohol consumption
Measured: Baseline and 10 weeks
Secondary outcomes (4)
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 and 10 weeks
Hamilton Anxiety and Depression Scale (HADS)
Change in total HADS score, as a summarized measure of depression and anxiety, respectively
Measured: Baseline and 10 weeks
EQ5
Change in total EQ5 score, as a summarized measure of quality of life
Measured: Baseline and 10 weeks
WHOQOL-BREF
Change in total WHOQOL-BREF score, as a summarized measure of quality of life
Measured: Baseline and 10 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 startDec 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 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
- NCT02384304
- Sponsor's protocol ID
- 2012/1761-31/5
- Status last verified
- Aug 2015
- First submitted
- 26 Feb 2015
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sundström, C., Berman, A. H., Sinadinovic, K., & Johansson, M. (2013). Internet-based relapse prevention with therapist support for help-seeking problematic alcohol users: a randomized pilot study. Addiction science & clinical practice, 8(1), 1-1.
Sundstrom C, Gajecki M, Johansson M, Blankers M, Sinadinovic K, Stenlund-Gens E, Berman AH. Guided and Unguided Internet-Based Treatment for Problematic Alcohol Use - A Randomized Controlled Pilot Trial. PLoS One. 2016 Jul 6;11(7):e0157817. doi: 10.1371/journal.pone.0157817. eCollection 2016.
PubMed 27383389
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided and Unguided Internet Treatment for Problematic Alcohol Use: A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT02384304
- Acronym / sponsor ID
- 2012/1761-31/5
- Conditions
- Alcohol Abuse, Alcohol Addiction
- Keywords
- randomized controlled trial, alcohol, internet, internet based therapy, cognitive behavior therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (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 was to determine whether a 10-week internet-based program based on cognitive behavioral therapy (CBT) is effective in the treatment of alcohol problems, and if having therapist guidance leads to greater effects.
Detailed description
Objectives: An 10 week Internet-based self-help program based on cognitive behavioral therapy (CBT) was tested among Internet help seekers.The design was a three-armed randomized controlled design, and outcomes were measured in terms of changes in problematic alcohol use, as well as depression, anxiety and quality of life. 80 participants were recruited entirely online from an open access website and randomized into three different groups. All participants had access to the same self-help program. However, one group was given a choice between two forms of therapist guidance (messages or weekly chat sessions), one group received therapist guidance in the form of secure messages, and one group received no therapist guidance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Choice | Experimental | Behavioral: ChoiceA self help program consisting of 8 modules. Patients will have access to therapist support through either messages or chat sessions |
| Messages | Experimental | Behavioral: MessagesA self help program consisting of 8 modules. Patients will have access to therapist support through messages |
| Self help | Active comparator | Behavioral: Self helpA relapse intervention program consisting of 8 modules. Patients will have no access to therapist support |
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 ≥ 8 p or more for men and ≥ 6 p or more for women in the Alcohol Use Identification Scale
Key exclusion criteria (1 listed)
- not adequately fluent in Swedish
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 |
|---|---|---|
| ChoiceA self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions | Behavioural | Choice |
| MessagesA self help program consisting of 8 modules and access to therapist guidance through messages | Behavioural | Messages |
| Self helpA self help program consisting of 8 modules | Behavioural | Self help |
Primary outcome
Time Line Follow Back (TLFB)
Time frame: Baseline and 10 weeks
Change in total TLFB score (consumption during preceding week), as a summarized measure of alcohol consumption
4 secondary outcomes
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Baseline and 10 weeks
Hamilton Anxiety and Depression Scale (HADS)
Time frame: Baseline and 10 weeks
EQ5
Time frame: Baseline and 10 weeks
WHOQOL-BREF
Time frame: Baseline and 10 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 2 Sep 2015.
- BackgroundSundström, C., Berman, A. H., Sinadinovic, K., & Johansson, M. (2013). Internet-based relapse prevention with therapist support for help-seeking problematic alcohol users: a randomized pilot study. Addiction science & clinical practice, 8(1), 1-1.
- Derived from this study: PubMed 27383389Sundstrom C, Gajecki M, Johansson M, Blankers M, Sinadinovic K, Stenlund-Gens E, Berman AH. Guided and Unguided Internet-Based Treatment for Problematic Alcohol Use - A Randomized Controlled Pilot Trial. PLoS One. 2016 Jul 6;11(7):e0157817. doi: 10.1371/journal.pone.0157817. eCollection 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 Choice, Messages and Self help 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 3 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: finished, as of the sponsor's last update on 2 Sep 2015. 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 and 10 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 NCT02384304, which also lists 2 linked publications.
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 2 Sep 2015.