ERP Plus Improv Group Therapy for OCD (IMPROVE Study)

May 27, 2025 updated by: Carolyn Rodriguez, Stanford University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • 401 Quarry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERP combined with Improv Group Therapy
Participants will attend 90-minute ERP + improv group therapy sessions for 12 consecutive weeks. They will also complete homework between sessions, answer questions, and complete questionnaires.
Other: Group Improv sessions
Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.
Other Names:
  • Improv Comedy
Behavioral: Group Exposure and Response Prevention (ERP) Therapy
Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.
Other Names:
  • ERP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time Frame: Baseline and up to 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Intolerance of Uncertainty Score
Time Frame: Baseline and up to 12 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Carolyn Rodriguez, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2024

Primary Completion (Actual)

April 17, 2025

Study Completion (Actual)

April 18, 2025

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2025

Last Update Submitted That Met QC Criteria

May 27, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69668

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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