Obsessive Compulsive DisorderNCT01348529
Internet Cognitive Behavior Therapy (CBT) for Obsessive Compulsive Disorder (OCD)
A study testing Internet CBT in people with Obsessive Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The main aim of this study is to test whether cognitive behavior therapy could be effective in treating obsessive compulsive disorder. Here, the investigators test the in group effects of a 15 week long treatment delivered via the Internet for residents in Stockholm County. 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 CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Mar 2011
- 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
- Diagnosed with Obsessive compulsive disorder according to the DSM criteria
- Be at least 18 years old
- YBOCS >7
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.
Sweden1 site
Internetpsykatrienheten, M46, Psykiatri sydväst
Stockholm, SE-141 86
About this study
Official title: Internet-based Cognitive Behavior Therapy for Obsessive Compulsive Disorder: A Pilot Study
The main aim of this study is to test whether cognitive behavior therapy could be effective in treating obsessive compulsive disorder. Here, the investigators test the in group effects of a 15 week long treatment delivered via the Internet for residents in Stockholm County.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Internet CBT
- Keywords
- OCD, CBT, Reducing OCD symptoms
- 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 CBTBehavioural
Internet-delivered cognitive behavioral therapy with therapist support.
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT | Experimental | Internet-delivered cognitive behavioral therapy with therapist support. Receives: Behavioral: Internet CBT |
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 15 weeks and 6 months after treatment.
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: Psychiatrist visit at baseline, after 15 weeks of treatment and 6 months after treatment.
Secondary outcomes (5)
Change from Baseline of cost data after 15 weeks and 6 months after treatment.
"Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry". In this questionnaire, patients register their monthly health care consumption (e.g. GP visits) as well as time spent in informal health enhancing activities (e.g. self-help groups and informal care from friends). In addition, work loss and work cutback both at work and in the domestic realm is measured.
Measured: Self-ratings at baseline, after 15 weeks of treatment and 6 months after treatment.
Change from Baseline of depressive symptoms after 15 weeks and 6 months after treatment.
The Montgomery Åsberg Depression Rating Scale
Measured: Sel-ratings at baseline, after 15 weeks of treatment and 6 months after treatment.
Change from Baseline of obsessions and compulsions after 15 weeks and 6 months after treatment.
Obsessions and Compulsions Inventory Revised
Measured: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
Change from Baseline of quality of life after 15 weeks and 6 months after treatment
EuroQol
Measured: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
Change from Baseline of quality of life after 15 weeks and 6 months after treatment
Quality of life inventory
Measured: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2011
- Study completionMar 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348529
- Sponsor's protocol ID
- OCDP1
- Status last verified
- Sep 2010
- First submitted
- 8 Nov 2010
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Andersson E, Ljotsson B, Hedman E, Kaldo V, Paxling B, Andersson G, Lindefors N, Ruck C. Internet-based cognitive behavior therapy for obsessive compulsive disorder: a pilot study. BMC Psychiatry. 2011 Aug 3;11:125. doi: 10.1186/1471-244X-11-125.
PubMed 21812991
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 Pilot Study
- ClinicalTrials.gov ID
- NCT01348529
- Acronym / sponsor ID
- OCDP1
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- OCD, CBT, Reducing OCD symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2010 (actual)
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 5 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.
The main aim of this study is to test whether cognitive behavior therapy could be effective in treating obsessive compulsive disorder. Here, the investigators test the in group effects of a 15 week long treatment delivered via the Internet for residents in Stockholm County.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet CBT | Experimental | Behavioral: Internet CBTInternet-delivered cognitive behavioral therapy with 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)
- Diagnosed with Obsessive compulsive disorder according to the DSM criteria
- Be at least 18 years old
- YBOCS >7
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 CBTInternet-delivered cognitive behavioral therapy with therapist support. | Behavioural | Internet CBT |
Primary outcome
Change from Baseline of obsessions and compulsions after 15 weeks and 6 months after treatment.
Time frame: Psychiatrist visit at baseline, after 15 weeks of treatment and 6 months after treatment.
Yale Brown Obsessive Compulsive Scale (Y-BOCS)
5 secondary outcomes
Change from Baseline of cost data after 15 weeks and 6 months after treatment.
Time frame: Self-ratings at baseline, after 15 weeks of treatment and 6 months after treatment.
Change from Baseline of depressive symptoms after 15 weeks and 6 months after treatment.
Time frame: Sel-ratings at baseline, after 15 weeks of treatment and 6 months after treatment.
Change from Baseline of obsessions and compulsions after 15 weeks and 6 months after treatment.
Time frame: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
Change from Baseline of quality of life after 15 weeks and 6 months after treatment
Time frame: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
Change from Baseline of quality of life after 15 weeks and 6 months after treatment
Time frame: Self-ratings at baseline, after 15 weeks of treatment and at 6 months after treatment.
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 21812991Andersson E, Ljotsson B, Hedman E, Kaldo V, Paxling B, Andersson G, Lindefors N, Ruck C. Internet-based cognitive behavior therapy for obsessive compulsive disorder: a pilot study. BMC Psychiatry. 2011 Aug 3;11:125. doi: 10.1186/1471-244X-11-125.
- Related InfoLink 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 study testing Internet CBT 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 3 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. 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?
Change from Baseline of obsessions and compulsions after 15 weeks and 6 months after treatment. (time frame: Psychiatrist visit at baseline, after 15 weeks of treatment and 6 months after treatment.). 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 NCT01348529, 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.