- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07103902
- Original Trial
Aerobic Exercise and Obsessive-Compulsive Disorder Symptoms
Effects of Aerobic Exercise on Obsessive-Compulsive Disorder Symptoms and Cognitive Flexibility
The purpose of this study is to examine the acute effects of exercise on cognitive flexibility and symptom reactivity. The main questions it aims to answer are:
Does moderate intensity physical activity reduce subjective distress, compulsive urges, and intrusions- and increase cognitive flexibility- in adults with obsessive-compulsive disorder compared to low-intensity physical activity?
Researchers will compare low- to moderate-intensity exercise to see if moderate physical activity increases cognitive flexibility and reduces symptom reactivity in adults with obsessive-compulsive disorder (OCD).
Participants will:
Complete self-report surveys, psychiatric interviews, and cognitive tasks.
Be assigned to either a low- or moderate-intensity exercise condition and complete physical activity.
Repeat cognitive and symptom measures following the exercise intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The proposed study aims to determine if moderate physical activity increases cognitive flexibility (aim 1) and reduces symptom reactivity (aim 2) in adults with obsessive-compulsive disorder (OCD).
Adults with obsessive-compulsive disorder (OCD) will be asked to participate in this study, which consists of two visits in addition to a self-report survey between these two visits.
This study will randomize 50 adults with obsessive-compulsive disorder (OCD) for aims 1 and 2.
First, participants will complete a phone screen to determine preliminary eligibility. During Session 1, participants will be consented and complete the diagnostic interview for anxiety, mood, and obsessive-compulsive related disorders (DIAMOND), the baseline probabilistic reversal learning (PRL) task, the symptom reactivity task, and self-report measures in-person. Between sessions 1 and 2, participants will be asked to complete several self-report measures via RedCap survey link.
Session 2 will take place 7-10 days following Session 1. Upon arrival to the lab, participants will be randomized (1:1) to a moderate-intensity physical activity or a low-intensity control condition. Randomization will be stratified based on sex and age to minimize demographic differences. Participants will be blind to allocation.
Individuals assigned to the moderate-intensity physical activity condition will engage in 20 minutes of cycling at approximately 70% max heart rate with a 2.5 minute warm up and a 2.5 minute cool down. In the low-intensity control condition, participants will cycle for 20 minutes at a 40-50% max heart rate with a 2.5 minute warm up and a 2.5 minute cool down. Participants will be instructed to maintain pedaling speed within ranges appropriate for each condition (e.g., 30-40 RPM for low-intensity) and research staff will adjust resistance level throughout the session to ensure that they stay within the target heart rate zones. Participants will be asked to rate their perceived exertion at five minute intervals throughout the session.
Following moderate- or low-intensity exercise, participants will complete follow-up administrations of cognitive flexibility and symptom reactivity tasks.
Cognitive flexibility will be assessed using the computerized Lucky Picture Selection Game, a probabilistic reversal learning (PRL) task. Participants choose between three images to earn points for a monetary bonus, with one image being the "lucky picture." The task includes ~260 trials across low and high volatility blocks, reflecting reversal frequency.
Symptom reactivity will be assessed using the The Braga Obsessive Compulsive Symptom Image Set (BOCI), an open-source, validated task designed to provoke obsessive-compulsive disorder (OCD) symptoms across washing, checking, and symmetry symptom dimensions.
Exercise intensity will be measured as a function of maximum heart rate. A PolarTech chest-strap heart rate monitor will be used during the exercise/control conditions to maintain the target intensity level. Heart rate will be monitored continuously throughout the session.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emily Weiss, PhD
- Phone Number: 203-858-1225
- Email: emily.weiss@yale.edu
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Temple Medical Center
-
Principal Investigator:
- Thomas Adams, PhD
-
Contact:
- Emily Weiss, PhD
- Email: emily.weiss@yale.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults, age 18 to 64 years
- Meet diagnostic criteria for OCD (per the DIAMOND)
- Stable psychiatric or medication treatment (if ≥4-weeks), or if no active treatment. Psychotropic medications will be reviewed with the study psychiatrist on a case by case basis.
Exclusion Criteria:
- Active or unmanaged psychotic disorders, pervasive developmental disorders, bipolar disorder, current substance use disorder (moderate-to-severe), or high risk for suicide (defined as attempt, plan, or intent within past 3 months)
- Documented motor impairments and medical condition(s) that prohibit physical exercise
- Those who are pregnant or trying to become pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Moderate-Intensity Exercise
|
Participants will engage in 20 minutes of cycling at approximately 70% max heart rate with a 2.5 minute warm up and a 2.5 minute cool down.
|
|
Other: Low-Intensity Exercise
Control
|
Participants will engage in 20 minutes of cycling at approximately 40-50% max heart rate with a 2.5 minute warm up and a 2.5 minute cool down.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive flexibility will be assessed using a probabilistic reversal learning (PRL) task called the Lucky Picture Selection Game.
Time Frame: Cognitive flexibility will be initially measured on day 1. Follow-up administrations will be completed 7-10 days later after the exercise intervention during session 2.
|
Cognitive flexibility will be initially measured on day 1. Follow-up administrations will be completed 7-10 days later after the exercise intervention during session 2.
|
|
|
Symptom reactivity will be assessed using the Braga Obsessive Compulsive Symptom Image Set (BOCI).
Time Frame: Symptom reactivity will be initially measured on day 1. Follow-up administrations will be completed 7-10 days later after the exercise intervention during session 2.
|
Symptom reactivity will be initially measured on day 1. Follow-up administrations will be completed 7-10 days later after the exercise intervention during session 2.
|
|
|
Exercise intensity will be measured using a PolarTech chest-strap HR monitor.
Time Frame: Exercise intensity will be measured during 7-10 days after baseline, during session 2.
|
Exercise intensity will be measured as a function of maximum heart rate (70% Max HR for moderate intensity condition and 40-50% max heart rate for low intensity condition).
|
Exercise intensity will be measured during 7-10 days after baseline, during session 2.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000040629
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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