Obsessive-compulsive DisorderPhase 2NCT01525576
Booster as an Adjunct to Internet-based Cognitive Behavior Therapy (CBT)
A Phase 2 study testing Booster in people with Obsessive-compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
In this trial, we test if adding an Internet-based booster program to regular Internet-based cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- Booster
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Jul 2012
- Phase
- Phase 2
- 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
- Signed consent
- Previously enrolled in our randomized controlled trial testing ICBT for OCD: NCT01347099
Who cannot join
- Suicidal ideation that could jeopardize participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of an Internet-based Booster Program for Obsessive-compulsive Disorder: A Randomized Controlled Trial
In this trial, we test if adding an Internet-based booster program to regular Internet-based cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive disorder (OCD).
Read the detailed description
Written consent form. Completing ICBT in our previous study: Please see NCT01347099 for more details.
- Conditions
- Obsessive-compulsive Disorder
- Being tested
- Booster
- Keywords
- booster program, internet, cbt, Study the specific effects of adding a booster program
- Medical subject headings
- Obsessive-Compulsive Disorder, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoosterBehavioural
3 week booster program + 2 additional weeks two months later for follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No offer of booster program. |
| Booster | Experimental | 3 week booster program + 2 additional weeks two months later for follow-up. Receives: Behavioral: Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline.
Yale Brown Obsessive Compulsive Scale (Y-BOCS). Analysis will examine the frequency of relapse from remission between the groups. Furthermore, frequency of incremental cases of remission will be compared between the groups.
Measured: 3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended
Secondary outcomes (4)
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Obsessive Compulsive Scale - Revised (OCI-R)
Measured: 3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Trimbos Institute Cost-assessment for Psychiatry (TIC-P)
Measured: 3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Montgomery Asberg Depression Rating Scale
Measured: 3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Euroqol
Measured: 3 months before treatment, 6 and 18 months after treatment has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Rück, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01525576
- Sponsor's protocol ID
- OCD_B
- Status last verified
- Jul 2012
- First submitted
- 1 Feb 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Internet-based Booster Program for Obsessive-compulsive Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01525576
- Acronym / sponsor ID
- OCD_B
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- booster program, internet, cbt, Study the specific effects of adding a booster program
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Feb 2012 (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.
In this trial, we test if adding an Internet-based booster program to regular Internet-based cognitive behavior therapy (ICBT) is effective for patients with obsessive-compulsive disorder (OCD).
Detailed description
Written consent form. Completing ICBT in our previous study: Please see NCT01347099 for more details.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No offer of booster program. |
| Booster | Experimental | Behavioral: Booster3 week booster program + 2 additional weeks two months later for follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed consent
- Previously enrolled in our randomized controlled trial testing ICBT for OCD: NCT01347099
Key exclusion criteria (1 listed)
- Suicidal ideation that could jeopardize participation
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 |
|---|---|---|
| Booster3 week booster program + 2 additional weeks two months later for follow-up. | Behavioural | Booster |
Primary outcome
Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline.
Time frame: 3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended
Yale Brown Obsessive Compulsive Scale (Y-BOCS). Analysis will examine the frequency of relapse from remission between the groups. Furthermore, frequency of incremental cases of remission will be compared between the groups.
4 secondary outcomes
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Time frame: 3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Time frame: 3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Time frame: 3 months before treatment, 6 and 18 months after treatment has ended
Change from Baseline of obsessions and compulsions after 8 and 20 months.
Time frame: 3 months before treatment, 6 and 18 months after treatment has ended
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 31 Jul 2012.
- This is an amendment to NCT01347099Link 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Booster in people with Obsessive-compulsive Disorder, 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 2 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 31 Jul 2012. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline of obsessions and compulsions after 3, 8 and 20 months after baseline. (time frame: 3 months before treatment, 3 weeks after treatment starts, 6 and 18 months after treatment has ended). 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 31 Jul 2012.