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Cognitive-Behavioral Bibliotherapy for the Treatment of Obsessive Compulsive Disorder in Children and Adolescents

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00690729
First Posted: June 5, 2008
Last Update Posted: August 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
UConn Health
  Purpose
This 16-week program examines cognitive behavioral bibliotherapy to typical therapist-directed cognitive behavior therapy for children and adolescents with Obsessive Compulsive Disorder.

Condition Intervention
Obsessive-Compulsive Disorder Behavioral: Cognitive Behavioral Bibliotherapy Behavioral: Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by UConn Health:

Primary Outcome Measures:
  • Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • NIMH Clinician's Global Impression [ Time Frame: weeks 4, 8, 12, 16 ]
  • Children's Obsessional Compulsive Inventory [ Time Frame: weeks 4, 8, 12, and 16 ]
  • Child OCD Impact Scale [ Time Frame: weeks 4, 8, 12, 16 ]
  • March Anxiety Scale for Children [ Time Frame: weeks 4, 8, 12, 16 ]
  • Children's Depression Inventory [ Time Frame: weeks 4, 8, 12, 16 ]
  • Child Behavior Checklist [ Time Frame: weeks 4, 8, 12, 16 ]
  • Family Assessment Measure III [ Time Frame: weeks 4, 8, 12, 16 ]

Enrollment: 22
Study Start Date: July 2005
Study Completion Date: August 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family
Behavioral: Cognitive Behavioral Bibliotherapy
Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention
Active Comparator: 2
Cognitive Behavioral Therapy - therapist-directed exposure response prevention over a 12-week period
Behavioral: Cognitive Behavioral Therapy
Therapist-directed exposure and response prevention

Detailed Description:

This study is designed to compare self-directed bibliotherapy and therapist-directed cognitive behavioral therapy for children and adolescents with Obsessive Compulsive Disorder (OCD). Both treatments involve exposure and response prevention (EX/RP), in which the child confronts OCD fears and is asked to refrain from compulsive rituals (such as repetitive handwashing, counting, etc.). Participants are requested to complete an initial evaluation to determine diagnosis, and four follow-up evaluations to assess symptom severity and change due to treatment for a total of 16 weeks. Participant involvement to self-directed bibliotherapy versus traditional cognitive-behavioral treatment will be determined through random assignment.

In the bibliotherapy condition, the child or adolescent will meet with a therapist twice over the course of treatment, along with a parent. The therapist will discuss a self-directed program of EX/RP to be implemented at a pace deemed appropriate by child and parent at their own home. The child and parent will be provided with a manual designed to instruct them how to cope with Obsessive Compulsive Disorder. This treatment involves the parent and child reading the book, performing exercises, and monitoring symptoms on a weekly basis for 8 weeks.

In the therapist-directed treatment condition, the child or adolescent will meet weekly with a therapist along with their parent. The therapist, parent, and child will work together to design and implement a program of EX/RP. This treatment involves performing exercises, monitoring symptoms on a weekly basis, and completing homework assignments. Parents will be asked to help coach their child with at-home exercises challenging the Obsessive Compulsive Disorder. This treatment lasts 12 weeks.

Evaluations will be conducted following the completion of each treatment to assess the efficacy of each treatment on OCD symptoms. The treatment and evaluations for OCD are provided free of charge.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 8-18 years old
  • Primary diagnosis of Obsessive Compulsive Disorder
  • Both parent and child fluent in English
  • Parents must read at least a 7th grade reading level

Exclusion Criteria:

  • Primary psychiatric diagnosis other than OCD
  • Current threat of harm to self or others
  • New use or dosage change of OCD medication 60 days prior to starting program
  • Current involvement with another psychosocial therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690729


Locations
United States, Connecticut
Institute of Living
Hartford, Connecticut, United States, 06106
University of Connecticut
Storrs, Connecticut, United States, 06269
University of Connecticut
Waterbury, Connecticut, United States, 06702
University of Connecticut
West Hartford, Connecticut, United States, 06117
Sponsors and Collaborators
UConn Health
Investigators
Principal Investigator: Kimberli Treadwell, Ph.D. University of Connecticut
  More Information

Responsible Party: Kimberli Treadwell/Assistant Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT00690729     History of Changes
Other Study ID Numbers: H06-170
First Submitted: June 3, 2008
First Posted: June 5, 2008
Last Update Posted: August 30, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders