NCT01809990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

1 year

First QC Date

February 17, 2013

Last Update Submit

June 27, 2014

Conditions

Obsessive-Compulsive Disorder

Keywords

cognitive behavior therapypediatric obsessive-compulsive disorderinternet-delivered cognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (5)

  • Spence Child Anxiety Scale - Child and Parent version

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

  • Child Depression Inventory

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

  • Strengths Difficulties Questionnaire

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

  • Children's Obsessional Compulsive Inventory Revised

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

  • Child Obsessive-Compulsive Impact Scale - Revised

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

Other Outcomes (4)

  • Patient Health Questionnaire PHQ-9

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

  • GAD-7

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

  • Obsessive Compulsive Inventory - Revised

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

  • +1 more other outcomes

Study Arms (1)

internet-delivered cognitive behavior therapy

EXPERIMENTAL

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

Behavioral: Internet-delivered Cognitive Behavior Therapy

Interventions

Internet-delivered Cognitive Behavior TherapyBEHAVIORAL
internet-delivered cognitive behavior therapy

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska insititute

Stockholm, Sweden

Location

Related Publications (11)

  • 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.

    PMID: 21743772BACKGROUND

  • 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.

    PMID: 12501574BACKGROUND

  • 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.

    PMID: 9255702BACKGROUND

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

    PMID: 4089116BACKGROUND

  • 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.

    PMID: 11556941BACKGROUND

  • 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.

    PMID: 18088221BACKGROUND

  • 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.

    PMID: 9183141BACKGROUND

  • 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.

    PMID: 12550826BACKGROUND

  • 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.

    PMID: 9648330BACKGROUND

  • 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.

    PMID: 16717171BACKGROUND

  • 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.

    PMID: 24949622DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Eva Serlachius, PhD, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 17, 2013

First Posted

March 13, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

SE(1)