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

Sponsor:	University of Connecticut
Information provided by:	University of Connecticut Health Center
ClinicalTrials.gov Identifier:	NCT00690729

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder

U.S. FDA Resources

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 ]

Estimated Enrollment:	30
Study Start Date:	July 2005
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Bibliotherapy	Behavioral: Cognitive Behavioral Bibliotherapy Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention
2: Active Comparator Cognitive Behavioral Therapy	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690729

Contacts

Contact: Kimberli Treadwell, Ph.D.

203-236-9849

Kimberli.Treadwell@UConn.edu

Locations

United States, Connecticut
University of Connecticut	Recruiting
Storrs, Connecticut, United States, 06269
University of Connecticut	Recruiting
Waterbury, Connecticut, United States, 06702
University of Connecticut	Recruiting
West Hartford, Connecticut, United States, 06117
Anxiety Disorder Center; Institute of Living	Recruiting
Hartford, Connecticut, United States, 06106

Sponsors and Collaborators

University of Connecticut

Investigators

Principal Investigator:

Kimberli Treadwell, Ph.D.

University of Connecticut

More Information

No publications provided

Responsible Party:	University of Connecticut ( Kimberli Treadwell/Assistant Professor )
Study ID Numbers:	H06-170
Study First Received:	June 3, 2008
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00690729 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Pathologic Processes
Disease
Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

ClinicalTrials.gov processed this record on November 27, 2009