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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690729
• Other study ID #: H06-170
• Status: Completed
• Phase: N/A
• First received: June 3, 2008
• Last updated: August 26, 2010
• Start date: July 2005
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This 16-week program examines cognitive behavioral bibliotherapy to typical therapist-directed cognitive behavior therapy for children and adolescents with Obsessive Compulsive Disorder.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Cognitive Behavioral Bibliotherapy
Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention
• Cognitive Behavioral Therapy
Therapist-directed exposure and response prevention

Locations

Country	Name	City	State
United States	Institute of Living	Hartford	Connecticut
United States	University of Connecticut	Storrs	Connecticut
United States	University of Connecticut	Waterbury	Connecticut
United States	University of Connecticut	West Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Yale-Brown Obsessive Compulsive Scale		12 weeks	No
Secondary	NIMH Clinician's Global Impression		weeks 4, 8, 12, 16	No
Secondary	Children's Obsessional Compulsive Inventory		weeks 4, 8, 12, and 16	No
Secondary	Child OCD Impact Scale		weeks 4, 8, 12, 16	No
Secondary	March Anxiety Scale for Children		weeks 4, 8, 12, 16	No
Secondary	Children's Depression Inventory		weeks 4, 8, 12, 16	No
Secondary	Child Behavior Checklist		weeks 4, 8, 12, 16	No
Secondary	Family Assessment Measure III		weeks 4, 8, 12, 16	No