Obsessive-Compulsive DisorderNCT00690729
Cognitive-Behavioral Bibliotherapy for the Treatment of Obsessive Compulsive Disorder in Children and Adolescents
A study testing Cognitive Behavioral Bibliotherapy and Cognitive Behavioral Therapy in people with Obsessive-Compulsive Disorder, run by UConn Health at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Cognitive Behavioral Bibliotherapy and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2005to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Institute of Living
Hartford, Connecticut, 06106
University of Connecticut
Storrs, Connecticut, 06269
University of Connecticut
Waterbury, Connecticut, 06702
University of Connecticut
West Hartford, Connecticut, 06117
About this study
Official title: Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents
This 16-week program examines cognitive behavioral bibliotherapy to typical therapist-directed cognitive behavior therapy for children and adolescents with Obsessive Compulsive Disorder.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Cognitive Behavioral Bibliotherapy, Cognitive Behavioral Therapy
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral BibliotherapyBehavioural
Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention
Cognitive Behavioral TherapyBehavioural
Therapist-directed exposure and response prevention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family Receives: Behavioral: Cognitive Behavioral Bibliotherapy |
| 2 | Active comparator | Cognitive Behavioral Therapy - therapist-directed exposure response prevention over a 12-week period Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Yale-Brown Obsessive Compulsive Scale
Measured: 12 weeks
Secondary outcomes (7)
NIMH Clinician's Global Impression
Measured: weeks 4, 8, 12, 16
Children's Obsessional Compulsive Inventory
Measured: weeks 4, 8, 12, and 16
Child OCD Impact Scale
Measured: weeks 4, 8, 12, 16
March Anxiety Scale for Children
Measured: weeks 4, 8, 12, 16
Children's Depression Inventory
Measured: weeks 4, 8, 12, 16
Child Behavior Checklist
Measured: weeks 4, 8, 12, 16
Family Assessment Measure III
Measured: weeks 4, 8, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJul 2005
- Primary completionMar 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Investigators
- Kimberli Treadwell, Ph.D., Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690729
- Sponsor's protocol ID
- H06-170
- Status last verified
- Aug 2010
- First submitted
- 3 Jun 2008
- Last updated
- 30 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents
- ClinicalTrials.gov ID
- NCT00690729
- Acronym / sponsor ID
- H06-170
- Conditions
- Obsessive-Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 16-week program examines cognitive behavioral bibliotherapy to typical therapist-directed cognitive behavior therapy for children and adolescents with Obsessive Compulsive Disorder.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioral BibliotherapyBibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family |
| 2 | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy - therapist-directed exposure response prevention over a 12-week period |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral BibliotherapyMinimal therapist direction for self-guided bibliotherapy involving exposure and response prevention | Behavioural | 1 |
| Cognitive Behavioral TherapyTherapist-directed exposure and response prevention | Behavioural | 2 |
Primary outcome
Child Yale-Brown Obsessive Compulsive Scale
Time frame: 12 weeks
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberli Treadwell, Ph.D. principal investigator
University of Connecticut
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Bibliotherapy and Cognitive Behavioral Therapy in people with Obsessive-Compulsive Disorder, run by UConn Health at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Yale-Brown Obsessive Compulsive Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2010.