Back to results

Internet-delivered CBT for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study

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 cognitive behavior therapy, pediatric obsessive-compulsive disorder, internet-delivered cognitive behavior therapy

Eligibility Criteria

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

Inclusion Criteria:

a primary diagnosis of OCD as defined by DSM-IV TR
a total score of above 15 on the 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
signed informed consent

Exclusion Criteria:

diagnosed autism spectrum disorder, psychosis or bipolar disorder
suicidal ideation
ongoing substance dependence
subject not able to read or understand the basics of the ICBT self-help material
completed CBT for OCD within last 12 months (defined as at least 5 sessions CBT including exposure and response prevention)
ongoing psychological treatment for OCD or another anxiety disorder

Sites / Locations

Karolinska insititute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

internet-delivered cognitive behavior therapy

Arm Description

Participants will be assigned to a 12 weeks internet-delivered cognitive behavior therapy program including therapist contact via an internet platform and telephone.

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 6 months after treatment.

Secondary Outcome Measures

Spence Child Anxiety Scale - Child and Parent version

Spence Child Anxiety Scale - Child and Parent version (SCAS/P, Spence, 1998) will be used as a child and parent self-report measure of anxiety related psychopathology.

Child Depression Inventory

Symptom severity of depression in the adolescent will be assessed with Child Depression Inventory (CDI, Kovacs, 1985).

Strengths Difficulties Questionnaire

Strengths Difficulties Questionnaire (SDQ, Goodman, 1997) is a widely used self- and parent-report behavioral screening questionnaire with six subscales: emotional problems, conduct problems, hyperactivity-inattention, peer problems, prosocial behavior

Children's Obsessional Compulsive Inventory Revised

The Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003) is a self- and parent-report measure of pediatric OCD symptom severity.

Child Obsessive-Compulsive Impact Scale - Revised

Child Obsessive-Compulsive Impact Scale - Revised (COIS-R, Piacentini, Peris, Bergman, Chang, & Jaffer, 2007) is a self- and parent-report scale of OCD symptom impact on everyday life.

Full Information

NCT ID

NCT01809990

First Posted

February 17, 2013

Last Updated

June 27, 2014

Sponsor

Eva Serlachius

Collaborators

Region Stockholm

1. Study Identification

Unique Protocol Identification Number

NCT01809990

Brief Title

Internet-delivered CBT for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study

Official Title

Internet-delivered Cognitive Behavior Therapy for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Eva Serlachius

Collaborators

Region Stockholm

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main goal of this trial is to study the feasibility and effectiveness of internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder.

6. Conditions and Keywords

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

Obsessive-Compulsive Disorder

Keywords

cognitive behavior therapy, pediatric obsessive-compulsive disorder, internet-delivered cognitive behavior therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

internet-delivered cognitive behavior therapy

Arm Type

Experimental

Arm Description

Participants will be assigned to a 12 weeks internet-delivered cognitive behavior therapy program including therapist contact via an internet platform and telephone.

Intervention Type

Behavioral

Intervention Name(s)

Internet-delivered Cognitive Behavior Therapy

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 6 months after treatment.

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Secondary Outcome Measure Information:

Title

Spence Child Anxiety Scale - Child and Parent version

Description

Spence Child Anxiety Scale - Child and Parent version (SCAS/P, Spence, 1998) will be used as a child and parent self-report measure of anxiety related psychopathology.

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Title

Child Depression Inventory

Description

Symptom severity of depression in the adolescent will be assessed with Child Depression Inventory (CDI, Kovacs, 1985).

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Title

Strengths Difficulties Questionnaire

Description

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Title

Children's Obsessional Compulsive Inventory Revised

Description

The Children's Obsessional Compulsive Inventory Revised, (CHOCI-R, Shafran et al., 2003) is a self- and parent-report measure of pediatric OCD symptom severity.

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Title

Child Obsessive-Compulsive Impact Scale - Revised

Description

Child Obsessive-Compulsive Impact Scale - Revised (COIS-R, Piacentini, Peris, Bergman, Chang, & Jaffer, 2007) is a self- and parent-report scale of OCD symptom impact on everyday life.

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Other Pre-specified Outcome Measures:

Title

Patient Health Questionnaire PHQ-9

Description

Patient Health Questionnaire PHQ-9 (Kroenke, Spitzer, & Williams, 2001) is a brief self-report measure of depressive symptoms in adults. PHQ-9 will be used to measure parental depressive symptoms.

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Title

GAD-7

Description

GAD-7 (Spitzer, Kroenke, Williams, & Löwe, 2006) is a brief self-report measure of symptoms of general anxiety in adults. GAD-7 will be used to measure symptoms of anxiety in the parents.

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Title

Obsessive Compulsive Inventory - Revised

Description

Obsessive Compulsive Inventory - Revised (OCI-R, Foa et al., 2002) is a reliable and valid 18-item self-report scale for screening of OCD in adults and will be used to measure parental OC symptoms of both parents.

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

Title

Family Accommodation Scale, Parent-Report

Description

Family Accommodation Scale, Parent-Report (FAS-PR, Flessner et al., 2009). The parent-report version of the FAS consists of 12 items focusing on accommodation behaviors of parents with a child with OCD.

Time Frame

Baseline, 12 weeks after treatment starts, 3 and 6 months after treatment has ended

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-IV TR a total score of above 15 on the 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 signed informed consent Exclusion Criteria: diagnosed autism spectrum disorder, psychosis or bipolar disorder suicidal ideation ongoing substance dependence subject not able to read or understand the basics of the ICBT self-help material completed CBT for OCD within last 12 months (defined as at least 5 sessions 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, PhD, MD

Organizational Affiliation

Karolinska Institutet

Official's Role

Principal Investigator

Facility Information:

Facility Name

Karolinska insititute

City

Stockholm

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

21743772

Citation

Flessner CA, Sapyta J, Garcia A, Freeman JB, Franklin ME, Foa E, March J. Examining the Psychometric Properties of the Family Accommodation Scale-Parent-Report (FAS-PR). J Psychopathol Behav Assess. 2009 Mar;31(1):38-46. doi: 10.1007/s10862-010-9196-3.

Results Reference

background

PubMed Identifier

12501574

Citation

Foa EB, Huppert JD, Leiberg S, Langner R, Kichic R, Hajcak G, Salkovskis PM. The Obsessive-Compulsive Inventory: development and validation of a short version. Psychol Assess. 2002 Dec;14(4):485-96.

Results Reference

background

PubMed Identifier

9255702

Citation

Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.

Results Reference

background

PubMed Identifier

4089116

Citation

Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.

Results Reference

background

PubMed Identifier

11556941

Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Results Reference

background

PubMed Identifier

18088221

Citation

Piacentini J, Peris TS, Bergman RL, Chang S, Jaffer M. Functional impairment in childhood OCD: development and psychometrics properties of the Child Obsessive-Compulsive Impact Scale-Revised (COIS-R). J Clin Child Adolesc Psychol. 2007 Oct-Dec;36(4):645-53. doi: 10.1080/15374410701662790.

Results Reference

background

PubMed Identifier

9183141

Citation

Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.

Results Reference

background

PubMed Identifier

12550826

Citation

Shafran R, Frampton I, Heyman I, Reynolds M, Teachman B, Rachman S. The preliminary development of a new self-report measure for OCD in young people. J Adolesc. 2003 Feb;26(1):137-42. doi: 10.1016/s0140-1971(02)00083-0.

Results Reference

background

PubMed Identifier

9648330

Citation

Spence SH. A measure of anxiety symptoms among children. Behav Res Ther. 1998 May;36(5):545-66. doi: 10.1016/s0005-7967(98)00034-5.

Results Reference

background

PubMed Identifier

16717171

Citation

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

Results Reference

background

PubMed Identifier

24949622

Citation

Lenhard F, Vigerland S, Andersson E, Ruck C, Mataix-Cols D, Thulin U, Ljotsson B, Serlachius E. Internet-delivered cognitive behavior therapy for adolescents with obsessive-compulsive disorder: an open trial. PLoS One. 2014 Jun 20;9(6):e100773. doi: 10.1371/journal.pone.0100773. eCollection 2014.

Results Reference

derived

Learn more about this trial

Internet-delivered CBT for Adolescents With Obsessive-Compulsive Disorder - a Pilot Study

We'll reach out to this number within 24 hrs