Clinical trial NCT00045903: Cognitive Behavioral Therapy Plus Drug Treatment for Obsessive Compulsive Disorder
Official title: CBT Augmentation for SRI Pharmacotherapy in OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Cognitive Behavioral Therapy
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-09-17
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of two cognitive behavioral therapies (CBTs) in treating obsessive compulsive disorder (OCD) in patients who are taking medication but still have residual symptoms.

Detailed description: Participants remain on their current OCD medication and are randomly assigned to receive one of two CBTs: exposure and ritual prevention or stress management therapy. Exposure and ritual prevention involves imaginal and in-vivo exposure and requires that participants refrain from ritualizing. Stress management involves relaxation, assertiveness training, and structured problem-solving. Therapy occurs twice per week for 2 months. Participants are assessed verbally by an independent evaluator and are asked to complete self-rating forms. Patients who respond are followed for up to 1 additional year. Participants continue to take the same medication and the same monthly therapy for the first 6 months of follow-up. During the second 6 months of follow-up, participants discontinue therapy but continue taking the same medication.

For information on a related study, please follow this link:

http://clinicaltrials.gov/show/NCT00389493

Eligibility criteria: Inclusion Criteria:

* Obsessive-Compulsive Disorder (OCD) diagnosis
* Currently taking a serotonin reuptake inhibitor (SRI, i.e. clomipramine, fluoxetine, fluvoxamine, paroxetine, sertraline, or citalopram) for OCD

Exclusion Criteria:

* Medical or psychiatric conditions that would make participation in the study hazardous
* Intensive cognitive-behavioral therapy while on an adequate dose and duration of an SRI for OCD

Primary outcomes:
measure: Obsessive-compulsive symptoms measured at Month 2
timeFrame: 2 months
Secondary outcomes:
measure: General functioning measured at Month 2
timeFrame: 2 months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiactic Institute, Anxiety Disorders Clinic
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania Center for the Treatment and Study of Anxiety
state: Pennsylvania
Study officials:
affiliation: New York State Psychiatric Institute
name: Michael Liebowitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Edna Foa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farris SG, McLean CP, Van Meter PE, Simpson HB, Foa EB. Treatment response, symptom remission, and wellness in obsessive-compulsive disorder. J Clin Psychiatry. 2013 Jul;74(7):685-90. doi: 10.4088/JCP.12m07789.
citation: Foa EB, Simpson HB, Liebowitz MR, Powers MB, Rosenfield D, Cahill SP, Campeas R, Franklin M, Hahn CG, Hembree EA, Huppert JD, Schmidt AB, Vermes D, Williams MT. Six-month follow-up of a randomized controlled trial augmenting serotonin reuptake inhibitor treatment with exposure and ritual prevention for obsessive-compulsive disorder. J Clin Psychiatry. 2013 May;74(5):464-9. doi: 10.4088/JCP.12m08017.