Obsessive-Compulsive DisorderBiPOCDNCT02191631
Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study
A study testing Internet-delivered Cognitive Behavior Therapy in people with Obsessive-Compulsive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Internet-delivered Cognitive Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2014to Dec 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a primary diagnosis of OCD as defined by DSM-5
- a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS
- age between 12 and 17 years
- ability to read and write Swedish
- daily access to the internet
- a parent that is able to co-participate in the treatment
- Participants on psychotropic medication must have been on a stable dose for the last 6 weeks prior to baseline assessment
Who cannot join
- diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder
- suicidal ideation
- ongoing substance dependence
- subject not able to read or understand the basics of the ICBT material
- completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
- ongoing psychological treatment for OCD or another anxiety disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study
The effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.
Read the detailed description
The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Internet-delivered Cognitive Behavior Therapy
- Keywords
- OCD, adolescents, pediatric, internet, online, CBT
- 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-delivered Cognitive Behavior TherapyBehavioural
The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered CBT | Experimental | Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support. Receives: Behavioral: Internet-delivered Cognitive Behavior Therapy |
| Wait list | No intervention | Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Secondary outcomes (11)
Clinical Global Impression - Severity, CGI-S
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Clinical Global Impression - Improvement, CGI-I
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Parent Adherence EX/RP Scale, PEAS
Measured: Baseline, 6 and 12 weeks after treatment starts
Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Technology acceptance scale
Measured: Baseline, 6 and 12 weeks after treatment starts,
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
Measured: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
EQ-5D - quality of life
Measured: Baseline, 12 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 posted16 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2016
- Study completionDec 2016
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Serlachius, Karolinska Institutet
- Investigators
- Eva Serlachius, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191631
- Sponsor's protocol ID
- BiPOCD RCT
- Acronym
- BiPOCD
- Status last verified
- Dec 2016
- First submitted
- 3 Jul 2014
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lenhard F, Ssegonja R, Andersson E, Feldman I, Ruck C, Mataix-Cols D, Serlachius E. Cost-effectiveness of therapist-guided internet-delivered cognitive behaviour therapy for paediatric obsessive-compulsive disorder: results from a randomised controlled trial. BMJ Open. 2017 May 17;7(5):e015246. doi: 10.1136/bmjopen-2016-015246.
PubMed 28515196Lenhard F, Andersson E, Mataix-Cols D, Ruck C, Vigerland S, Hogstrom J, Hillborg M, Brander G, Ljungstrom M, Ljotsson B, Serlachius E. Therapist-Guided, Internet-Delivered Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Jan;56(1):10-19.e2. doi: 10.1016/j.jaac.2016.09.515. Epub 2016 Oct 25.
PubMed 27993223
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02191631
- Acronym / sponsor ID
- BiPOCD / BiPOCD RCT
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, adolescents, pediatric, internet, online, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Jul 2014 (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 effect of Internet-delivered Cognitive Behavior Therapy (ICBT) on adolescents (12 to 17 years) with Obsessive-Compulsive Disorder is studied. Participants are randomized to either ICBT or a no-treatment condition. We expect ICBT to be superior over the no-treatment condition.
Detailed description
The primary objective of this study is to test the efficacy of Internet-delivered cognitive behavior therapy (ICBT) for adolescents (12 - 17 years) with OCD. We aim to conduct a randomized controlled study with N = 66 participants. Participants will be randomly assigned to ICBT or a wait list condition, either lasting 12 weeks. The primary outcome measure is the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS). Study participants will be followed up 3 and 12 months after treatment. ICBT is expected to yield significantly better symptom reduction than the wait list condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered CBT | Experimental | Behavioral: Internet-delivered Cognitive Behavior TherapyParticipants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support. |
| Wait list | No intervention | –Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- a primary diagnosis of OCD as defined by DSM-5
- a total score of ≥ 16 on the Children's Yale-Brown Obsessive-Compulsive Scale, CY-BOCS
- age between 12 and 17 years
- ability to read and write Swedish
- daily access to the internet
Key exclusion criteria (6 listed)
- diagnosed autism spectrum disorder, psychosis or bipolar disorder, severe eating disorder
- suicidal ideation
- ongoing substance dependence
- subject not able to read or understand the basics of the ICBT material
- completed CBT for OCD within last 12 months (defined as at least 5 sessions of CBT including exposure and response prevention)
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-delivered Cognitive Behavior TherapyThe treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks. | Behavioural | Internet-delivered CBT |
Primary outcome
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment
11 secondary outcomes
Clinical Global Impression - Severity, CGI-S
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Clinical Global Impression - Improvement, CGI-I
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Parent Adherence EX/RP Scale, PEAS
Time frame: Baseline, 6 and 12 weeks after treatment starts
Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Education, Work and Social Adjustment Scale - child and parent version (EWSAS)
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
Technology acceptance scale
Time frame: Baseline, 6 and 12 weeks after treatment starts,
Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)
Time frame: Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended
EQ-5D - quality of life
Time frame: Baseline, 12 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 22 Dec 2016.
- Derived from this study: PubMed 28515196Lenhard F, Ssegonja R, Andersson E, Feldman I, Ruck C, Mataix-Cols D, Serlachius E. Cost-effectiveness of therapist-guided internet-delivered cognitive behaviour therapy for paediatric obsessive-compulsive disorder: results from a randomised controlled trial. BMJ Open. 2017 May 17;7(5):e015246. doi: 10.1136/bmjopen-2016-015246.
- Derived from this study: PubMed 27993223Lenhard F, Andersson E, Mataix-Cols D, Ruck C, Vigerland S, Hogstrom J, Hillborg M, Brander G, Ljungstrom M, Ljotsson B, Serlachius E. Therapist-Guided, Internet-Delivered Cognitive-Behavioral Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2017 Jan;56(1):10-19.e2. doi: 10.1016/j.jaac.2016.09.515. Epub 2016 Oct 25.
- Individual participant dataSharing planned: Undecided
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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.
Eva Serlachius, MD, 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 Internet-delivered Cognitive Behavior Therapy 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 7 inclusion and 6 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 22 Dec 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 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?
Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS (time frame: Baseline, 12 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 NCT02191631, 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 22 Dec 2016.