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

This study has been completed.
Sponsor:
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00690729
First received: June 3, 2008
Last updated: August 26, 2010
Last verified: August 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 University of Connecticut Health Center:

Primary Outcome Measures:
  • Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NIMH Clinician's Global Impression [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Children's Obsessional Compulsive Inventory [ Time Frame: weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Child OCD Impact Scale [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • March Anxiety Scale for Children [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Children's Depression Inventory [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Child Behavior Checklist [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Family Assessment Measure III [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Connecticut Health Center
Investigators
Principal Investigator: Kimberli Treadwell, Ph.D. University of Connecticut
  More Information

No publications provided

Responsible Party: Kimberli Treadwell/Assistant Professor, University of Connecticut
ClinicalTrials.gov Identifier: NCT00690729     History of Changes
Other Study ID Numbers: H06-170
Study First Received: June 3, 2008
Last Updated: August 26, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 19, 2014