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Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study (BiPOCD)

Primary Purpose

Obsessive-Compulsive Disorder

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Internet-delivered Cognitive Behavior Therapy

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring OCD, adolescents, pediatric, internet, online, CBT

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-delivered CBT

Wait list

Arm Description

Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.

Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical Global Impression - Severity, CGI-S

Clinical Global Impression - Improvement, CGI-I

Parent Adherence EX/RP Scale, PEAS

Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003)

Education, Work and Social Adjustment Scale - child and parent version (EWSAS)

Spence Child Anxiety Scale - Child and Parent version (SCAS-C/P, Spence, 1998

Child Depression Inventory - Short version (CDI-S, Kovacs, 1985)

Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009)

Technology acceptance scale

Trimbos/iMTA questionnaire for Costs associated with Psychiatric Illness - Child version (TiC-P)

EQ-5D - quality of life

Full Information

NCT ID

NCT02191631

First Posted

July 3, 2014

Last Updated

December 21, 2016

Sponsor

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT02191631

Brief Title

Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study

Acronym

BiPOCD

Official Title

Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder: A Randomized Controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Karolinska Institutet

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obsessive-Compulsive Disorder

Keywords

OCD, adolescents, pediatric, internet, online, CBT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Internet-delivered CBT

Arm Type

Experimental

Arm Description

Participants will receive 12 weeks of internet-delivered cognitive behavior therapy with psychologist support.

Arm Title

Wait list

Arm Type

No Intervention

Arm Description

Participants will receive no treatment for 12 weeks. After that period participants will receive Internet-delivered Cognitive Behavior Therapy.

Intervention Type

Behavioral

Intervention Name(s)

Internet-delivered Cognitive Behavior Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Children's Yale Brown Obsessive Compulsive Scale, CY-BOCS

Description

Change from Baseline of obsessions and compulsions after 12 weeks and at 3- and 12 months after treatment

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Secondary Outcome Measure Information:

Title

Clinical Global Impression - Severity, CGI-S

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Title

Clinical Global Impression - Improvement, CGI-I

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Title

Parent Adherence EX/RP Scale, PEAS

Time Frame

Baseline, 6 and 12 weeks after treatment starts

Title

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

Title

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

Title

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

Title

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

Title

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

Title

Technology acceptance scale

Time Frame

Baseline, 6 and 12 weeks after treatment starts,

Title

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

Title

EQ-5D - quality of life

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended

Other Pre-specified Outcome Measures:

Title

Measurement of homework adherence

Time Frame

Baseline, daily measurements until 12 weeks after baseline

Title

Number of Participants with Adverse Events

Time Frame

12 weeks after baseline

Title

DNA samples (from blood and/or saliva)

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eva Serlachius, MD, PhD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska Institutet

City

Stockholm

ZIP/Postal Code

171 77

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28515196

Citation

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. Erratum In: BMJ Open. 2017 Jun 21;7(6):e015246corr1.

Results Reference

derived

PubMed Identifier

27993223

Citation

Lenhard 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.

Results Reference

derived

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Internet-delivered CBT for Adolescents With OCD: A Randomized Controlled Study

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