NCT06265233

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

November 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

5 months

First QC Date

February 9, 2024

Last Update Submit

May 27, 2025

Conditions

Keywords

Behavioral TherapyExRP (Exposure and Response Prevention)ERPImprov comedyOCD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Intolerance of Uncertainty Score

    Baseline and up to 12 weeks

Study Arms (1)

ERP combined with Improv Group Therapy

EXPERIMENTAL

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 sessionsBehavioral: Group Exposure and Response Prevention (ERP) Therapy

Interventions

Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.

Also known as: Improv Comedy
ERP combined with Improv Group Therapy

Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.

Also known as: ERP
ERP combined with Improv Group Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

401 Quarry

Stanford, California, 94304, United States

Location

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Carolyn Rodriguez, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 20, 2024

Study Start

November 19, 2024

Primary Completion

April 17, 2025

Study Completion

April 18, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations