- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00690729
Cognitive-Behavioral Bibliotherapy for the Treatment of Obsessive Compulsive Disorder in Children and Adolescents
Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Connecticut
-
Hartford, Connecticut, United States, 06106
- Institute of Living
-
Storrs, Connecticut, United States, 06269
- University of Connecticut
-
Waterbury, Connecticut, United States, 06702
- University of Connecticut
-
West Hartford, Connecticut, United States, 06117
- University of Connecticut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Bibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family
|
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
|
Therapist-directed exposure and response prevention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Child Yale-Brown Obsessive Compulsive Scale
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
NIMH Clinician's Global Impression
Time Frame: weeks 4, 8, 12, 16
|
weeks 4, 8, 12, 16
|
Children's Obsessional Compulsive Inventory
Time Frame: weeks 4, 8, 12, and 16
|
weeks 4, 8, 12, and 16
|
Child OCD Impact Scale
Time Frame: weeks 4, 8, 12, 16
|
weeks 4, 8, 12, 16
|
March Anxiety Scale for Children
Time Frame: weeks 4, 8, 12, 16
|
weeks 4, 8, 12, 16
|
Children's Depression Inventory
Time Frame: weeks 4, 8, 12, 16
|
weeks 4, 8, 12, 16
|
Child Behavior Checklist
Time Frame: weeks 4, 8, 12, 16
|
weeks 4, 8, 12, 16
|
Family Assessment Measure III
Time Frame: weeks 4, 8, 12, 16
|
weeks 4, 8, 12, 16
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kimberli Treadwell, Ph.D., University of Connecticut
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H06-170
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive-Compulsive Disorder
-
Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
-
Baylor College of MedicineRecruitingObsessive-Compulsive Disorder | Cognitive Behavioral Therapy | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
-
Chaim HuijserLevvelRecruitingObsessive-Compulsive Disorder | Anxiety Disorders and Symptoms | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceNetherlands
-
Stanford UniversityCompletedObsessive Compulsive DisorderUnited States
-
NYU Langone HealthCompletedObsessive Compulsive DisorderUnited States
-
Massachusetts General HospitalActive, not recruitingObsessive Compulsive DisorderUnited States
-
Boston University Charles River CampusCompletedObsessive Compulsive DisorderUnited States
-
Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive DisorderUnited States
-
Karolinska InstitutetCompletedObsessive Compulsive DisorderSweden
-
Roseli ShavittCompleted
Clinical Trials on Cognitive Behavioral Bibliotherapy
-
Oregon Research InstituteNational Institute of Mental Health (NIMH)CompletedDepressionUnited States
-
University Hospital, Strasbourg, FranceCompletedStress - Prevention of Sleep Disorders, PTSD and DepressionFrance
-
University of California, San DiegoNational Institute of Mental Health (NIMH)Withdrawn
-
Baylor College of MedicineRecruitingGeneralized Anxiety Disorder | Panic Disorder | Panic Disorder With Agoraphobia | Separation Anxiety | Anxiety Disorder of Childhood | Panic Attacks | Social Anxiety Disorder of Childhood | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
-
Solent NHS TrustUniversity of Oxford; Talking Change (Solent NHS Trust); Constable & RobinsonCompletedSocial Anxiety Disorder | Cognitive Behavioral Therapy | BibliotherapyUnited Kingdom
-
University of Texas at AustinNational Institute of Mental Health (NIMH)Completed
-
National Yang Ming UniversityCompletedPediatric Cancer | Emotional DistressTaiwan
-
Far Eastern Memorial HospitalUnknownDepression | Inflammation | InsomniaTaiwan
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway