5dayOCD: Wait-list Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder (OCD)

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01194076

Collaborator

University of South Florida (Other), Fordham University (Other)

Enrollment

Locations

Arm

Duration (Months)

9.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine how well intensive cognitive-behavioral therapy (CBT) delivered over 5 days works in reducing Obsessive-Compulsive Disorder (OCD) symptoms in children and adolescents. Treatment will consist of exposure and response prevention with an added focus on teaching parents to be exposure coaches.

Condition or Disease	Intervention/Treatment	Phase
Obsessive Compulsive Disorder	Behavioral: 5-day intensive treatment	N/A

Detailed Description

Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do not receive CBT initially due, in part, to the lack of trained providers and geographic barriers (e.g., distance to such providers). Rather, the majority of youth with OCD receive psychiatric medication alone or together with unproven forms of psychotherapy. While some serotonergic medications have demonstrated utility in pediatric OCD, side effects can be common, response rates are modest at best, and symptom remission is rare. Storch et al. have shown that CBT can be delivered effectively in an intensive format over a 3-week time-span; however, even this shortened treatment approach involves considerable time and financial expenditure for those who do not have local access to CBT, including three week's time off from work and the cost of local room and board. Given this, more efficient ways of providing CBT need to be identified and tested to increase the number of people with access to this form of treatment. With this in mind, the proposed feasibility study examines the use of videophone technology to evaluate a 5-day cognitive-behavioral intervention for youth with OCD administered at multiple sites. A total of 30 youth will receive 10 60-75-minute sessions of CBT over 5 days (two sessions a day). Cognitive-behavioral therapy will be based on a demonstrated effective treatment protocol, and adapted for administration over a one-week time-span. We will utilize a month-long waitlist control to estimate treatment efficacy. Comprehensive assessments will be conducted by trained clinicians at relevant time-points (i.e., baseline, post-waitlist, post-treatment, follow-up) to assess symptom severity and impairment. Should supporting data be found, CBT delivered in a 5-day format would have the potential to help many more families who would otherwise remain untreated or inadequately treated.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Wait-list Feasibility Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric OCD

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5day intensive treatment	Behavioral: 5-day intensive treatment Exposure Based Cognitive Behavioral Therapy administered in 10 appointments over 5 days with an added focus on training parents to be exposure coaches

Arm

Intervention/Treatment

Experimental: 5day intensive treatment

Behavioral: 5-day intensive treatment

Exposure Based Cognitive Behavioral Therapy administered in 10 appointments over 5 days with an added focus on training parents to be exposure coaches

Outcome Measures

Primary Outcome Measures

Children's Yale Brown Obsessive Compulsive Scale (CYBOCS) [1 month before tx, pre-tx, post-tx, 3 month follow-up]
The CYBOCS is the gold standard measure of OCD symptoms. The primary outcome is the decrease in CYBOCS scores from pre-tx to post-tx, and post-tx to follow-up, compared to the change from 1 month before tx to pre-tx.

Secondary Outcome Measures

Spence children's anxiety scale [baseline, pre-tx, post-tx, 3 month follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients must meet the following inclusion criteria to be eligible for study participation:
Principal diagnosis of OCD on the ADIS-IV-P and CY-BOCS Total Score ≥ 16
No change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry
7 to 17 years old
Availability of at least one parent to accompany the child to all assessment sessions and be present for videophone assessments
Have a computer and high-speed internet within their home
English speaking.

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:
History of and/or current psychosis, autism, bipolar disorder, or current suicidality, oppositional defiant disorder, or eating disorder measured by the ADIS-IV-P and all available clinical information
Principal diagnosis other than OCD
Current a positive diagnosis in the caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit their ability to understand CBT (based on clinical interview).
Participants can be included if they are taking a selective serotonin reuptake inhibitor, SNRI, tricyclic, or antipsychotic provided that no medication changes were made 8 weeks prior to initiation of CBT or during treatment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Florida	Tampa	Florida	United States	33620
2	Mayo Clinic	Rochester	Minnesota	United States	55905
3	Fordham University	Bronx	New York	United States	10458