Obsessive-Compulsive DisorderNCT06265233
ERP Plus Improv Group Therapy for OCD (IMPROVE Study)
A study testing Group Improv sessions and Group Exposure and Response Prevention (ERP) Therapy in people with Obsessive-Compulsive Disorder, run by Stanford University at 1 site in United States.
Trial summary
The goal of this study is to pilot test a novel group therapy intervention for adults with OCD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Group Improv sessions and Group Exposure and Response Prevention (ERP) Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2024to 18 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Ability to speak and understand English
- Clinical diagnosis of obsessive-compulsive disorder (OCD)
Who cannot join
- Current active suicidality
- Medical or psychiatric illness that could interfere with study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Group Improv sessions, Group Exposure and Response Prevention (ERP) Therapy
- Keywords
- Behavioral Therapy, ExRP (Exposure and Response Prevention), ERP, Improv comedy, OCD
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Improv sessionsOther
Also called Improv Comedy
Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.
Group Exposure and Response Prevention (ERP) TherapyBehavioural
Also called ERP
Therapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Group Improv sessions; Behavioral: Group Exposure and Response Prevention (ERP) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 12 weeks
Secondary outcomes (1)
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.
Measured: Baseline and up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start19 Nov 2024
- Primary completion17 Apr 2025
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Rodriguez, Stanford University
- Investigators
- Carolyn Rodriguez, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265233
- Sponsor's protocol ID
- 69668
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Cognitive Behavioral Therapy (CBT) Plus Improv Group Therapy for OCD
- ClinicalTrials.gov ID
- NCT06265233
- Acronym / sponsor ID
- 69668
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Behavioral Therapy, ExRP (Exposure and Response Prevention), ERP, Improv comedy, OCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to pilot test a novel group therapy intervention for adults with OCD.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERP combined with Improv Group Therapy | Experimental | Other: Group Improv sessions, Behavioral: Group Exposure and Response Prevention (ERP) TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Ability to speak and understand English
- Clinical diagnosis of obsessive-compulsive disorder (OCD)
Key exclusion criteria (2 listed)
- Current active suicidality
- Medical or psychiatric illness that could interfere with study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Improv sessionsAlso: Improv ComedyTherapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions. | Other | ERP combined with Improv Group Therapy |
| Group Exposure and Response Prevention (ERP) TherapyAlso: ERPTherapist-led 90-minute exposure and response prevention (ERP) combined with improv sessions. | Behavioural | ERP combined with Improv Group Therapy |
Primary outcome
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.
1 secondary outcome
Change in Intolerance of Uncertainty Score
Time frame: Baseline and up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Stanford OCD Research Lab WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Rodriguez, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Improv sessions and Group Exposure and Response Prevention (ERP) Therapy in people with Obsessive-Compulsive Disorder, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.