Obsessive Compulsive DisorderPhase 2NCT01347099
Internet-based Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)
A Phase 2 study testing Internet-based cognitive behavior therapy and Support therapy on Internet in people with Obsessive Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder (OCD) but there is a lack of properly trained CBT therapists. One possible treatment alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study was therefore to evaluate ICBT for 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?
- Internet-based cognitive behavior therapy and Support therapy on Internet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2011to Jun 2011
- 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
- Primary diagnosis of obsessive compulsive disorder (OCD)
- At least 18 years old
- Able to read and write in swedish
- Computer access
Who cannot join
- other primary diagnosis
- substance abuse,
- psychosis,
- bipolar disorder,
- suicidal ideation,
- adjusted pharmacological treatment the last two months
Show all 11Show fewer
- current psychological treatment for OCD,
- been treated with CBT the last two years,
- serious somatic disease,
- Y---BOCS>31
- hoarding as primary OCD subtype
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Randomized Controlled Trial
Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder (OCD) but there is a lack of properly trained CBT therapists. One possible treatment alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study was therefore to evaluate ICBT for OCD.
Read the detailed description
This is a randomized controlled trial with 101 participants. The control group receives support therapy on demand on the Internet.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Internet-based cognitive behavior therapy, Support therapy on Internet
- Keywords
- CBT, OCD, Internet, Reduce symptom burden
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavior therapyBehavioural
Internet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks
Support therapy on InternetBehavioural
Internet-delivered support therapy. Contact with therapist thru an e-mail system. 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT | Experimental | Internet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks. Receives: Behavioral: Internet-based cognitive behavior therapy |
| Support therapy | Placebo comparator | 10 weeks. Therapist support contact through e-mail. Receives: Behavioral: Support therapy on Internet |
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 10 weeks and at 3- and 12 months after treatment.
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary outcomes (5)
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Obsessive Compulsive Scale - Revised (OCI-R)
Measured: Two days before treatment, once per week for 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Dimensional Obsessive Compulsive Scale (DOCS)
Measured: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after the treatment has ended
Change from Baseline of depressive symptoms after 10 weeks and at 3- and 12 months after treatment.
Montgomery Asberg Depression Rating Scale
Measured: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of meta cognitions after 10 weeks and at 3- and 12 months after treatment.
Obsessive Beliefs Scale
Measured: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of quality of life after 10 weeks and at 3- and 12 months after treatment.
Euroqol
Measured: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 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 posted4 May 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
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 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- Christian Rück, MD, PhD, Principal investigator, Department of Clinical Neuroscience, KI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347099
- Sponsor's protocol ID
- OCD-S
- Status last verified
- May 2011
- First submitted
- 2 May 2011
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersson E, Enander J, Andren P, Hedman E, Ljotsson B, Hursti T, Bergstrom J, Kaldo V, Lindefors N, Andersson G, Ruck C. Internet-based cognitive behaviour therapy for obsessive-compulsive disorder: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2193-203. doi: 10.1017/S0033291712000244. Epub 2012 Feb 21.
PubMed 22348650
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01347099
- Acronym / sponsor ID
- OCD-S
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- CBT, OCD, Internet, Reduce symptom burden
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011
- First posted
- 4 May 2011 (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.
Cognitive behavior therapy (CBT) is an effective treatment for obsessive compulsive disorder (OCD) but there is a lack of properly trained CBT therapists. One possible treatment alternative is Internet-based CBT (ICBT) with minimal therapist input. The aim of this study was therefore to evaluate ICBT for OCD.
Detailed description
This is a randomized controlled trial with 101 participants. The control group receives support therapy on demand on the Internet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet CBT | Experimental | Behavioral: Internet-based cognitive behavior therapyInternet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks. |
| Support therapy | Placebo comparator | Behavioral: Support therapy on Internet10 weeks. Therapist support contact through e-mail. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary diagnosis of obsessive compulsive disorder (OCD)
- At least 18 years old
- Able to read and write in swedish
- Computer access
Key exclusion criteria (11 listed)
- other primary diagnosis
- substance abuse,
- psychosis,
- bipolar disorder,
- suicidal ideation,
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 cognitive behavior therapyInternet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks | Behavioural | Internet CBT |
| Support therapy on InternetInternet-delivered support therapy. Contact with therapist thru an e-mail system. 10 weeks | Behavioural | Support therapy |
Primary outcome
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Time frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
5 secondary outcomes
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Time frame: Two days before treatment, once per week for 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of obsessions and compulsions after 10 weeks and at 3- and 12 months after treatment.
Time frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after the treatment has ended
Change from Baseline of depressive symptoms after 10 weeks and at 3- and 12 months after treatment.
Time frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of meta cognitions after 10 weeks and at 3- and 12 months after treatment.
Time frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of quality of life after 10 weeks and at 3- and 12 months after treatment.
Time frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 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 21 Mar 2018.
- Results publication: PubMed 22348650Andersson E, Enander J, Andren P, Hedman E, Ljotsson B, Hursti T, Bergstrom J, Kaldo V, Lindefors N, Andersson G, Ruck C. Internet-based cognitive behaviour therapy for obsessive-compulsive disorder: a randomized controlled trial. Psychol Med. 2012 Oct;42(10):2193-203. doi: 10.1017/S0033291712000244. Epub 2012 Feb 21.
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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.
Christian Rück, MD, PhD principal investigator
Department of Clinical Neuroscience, KI
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 Internet-based cognitive behavior therapy and Support therapy on Internet 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 4 inclusion and 11 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 21 Mar 2018. 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. Some participants in this study may receive a placebo. 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 10 weeks and at 3- and 12 months after treatment. (time frame: Two weeks before treatment, 10 weeks after treatment starts, 3 and 12 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?
On the ClinicalTrials.gov record for NCT01347099, 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 21 Mar 2018.