ERP Plus Improv Group Therapy for OCD (IMPROVE Study)

Obsessive-Compulsive Disorder Clinical Trial

Official title:

Pilot Study of Cognitive Behavioral Therapy (CBT) Plus Improv Group Therapy for OCD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06265233
• Other study ID #: 69668
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Study Team
• Phone: (650) 723-4095
• Email: ocdresearch[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to pilot test a novel group therapy intervention for adults with OCD.

Description:

The intervention will incorporate exposure and response prevention (ERP) with improvisational comedy ("improv") activities. ERP is the gold-standard treatment for OCD. Improv comedy is a type of theater in which actors perform without a script. This study aims to evaluate whether the intervention is helpful for reducing OCD symptoms and intolerance of uncertainty (a mechanism maintaining OCD). It will also explore whether the intervention is feasible and acceptable. During the group therapy sessions, participants will engage with improv comedy exercises that have been adapted to function as exposures for different types of OCD. Participants will: - attend an ERP + improv group therapy intervention (90-minute sessions for 12 weeks) - complete homework in-between sessions - answer questions - complete questionnaires.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age
• Ability to speak and understand English
• Clinical diagnosis of obsessive-compulsive disorder (OCD)

Exclusion Criteria:

• Current active suicidality
• Medical or psychiatric illness that could interfere with study participation

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Other:
• Group Improv sessions
Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.

Behavioral:
• Group Exposure and Response Prevention (ERP) Therapy
Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.

Locations

Country	Name	City	State
United States	401 Quarry	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)	Change in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% change on the YBOCS.	Baseline and up to 12 weeks
Secondary	Change in Intolerance of Uncertainty Score	Change in intolerance of uncertainty (IU) will be measured with the Intolerance of Uncertainty Scale - Short Form (IUS-12). IU is the tendency to respond negatively to uncertain situations. The IUS-12 is a 12-item self-report measure that assesses IU. Each item is assessed using a 5-point Likert scale ranging from 1 (not at all characteristic of me) to 5 (entirely characteristic of me).; It consists of two subscales: Prospective IU and Inhibitory IU. Prospective IU is the cognitive appraisal of a threat related to future uncertainty. Inhibitory IU refers to the behavioral inhibition related to uncertainty. The Prospective IU subscale is comprised of 7 items, while the Inhibitory IU subscale is comprised of 5 items. Scores are summed to generate the two subscale scores and a total score. Total IUS-12 scores range from 12 to 60, with higher scores indicating a higher IU.	Baseline and up to 12 weeks

External Links

•   Stanford OCD Research Lab Website