Obsessive Compulsive DisorderPhase 2NCT01242735
Exercise and Health Intervention for Patients With Obsessive Compulsive Disorder (OCD)
A Phase 2 study testing Aerobic exercise and Health and Wellness in people with Obsessive Compulsive Disorder, run by Butler Hospital at 1 site in United States.
Trial summary
The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Aerobic exercise and Health and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Mar 2015
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are between 18 and 65 years of age
- are sedentary, i.e. have not participated in regular aerobic physical exercise for at least 90 minutes per week during the past three months
- currently engaged in at least 12 weeks of stable dose pharmacotherapy and/or are currently engaged in cognitive-behavioral therapy for the past 13 weeks
- meet Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for OCD as assessed by the Structured Clinical Interview for DSM Disorders, Patient Version (SCID-P)
- have Y-BOCS score greater than 16
Who cannot join
- DSM-IV diagnosis of substance abuse/dependence except for nicotine dependence
- DSM-IV diagnosis of anorexia or bulimia nervosa
- DSM-IV diagnosis of bipolar disorder
- history of psychotic disorder or current psychotic symptoms
- current suicidality or homicidality
- marked organic impairment
- physical or medical problems that would not allow for safe exercise participation
- current pregnancy or intent to become pregnant during the next 12 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Efficacy of an Exercise Intervention for Patients With OCD
The purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing symptoms. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in managing the effects of OCD. If moderate-intensity aerobic exercise is efficacious in helping individuals with OCD manage obsessions and compulsions, this will establish that aerobic exercise may be a valuable adjunct to other OCD treatments such as medication and therapy.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Aerobic exercise, Health and Wellness
- Keywords
- Obsessive Compulsive Disorder, OCD, Exercise, Aerobic Exercise
- Medical subject headings
- Obsessive-Compulsive Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.
Health and WellnessBehavioural
12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 12-week moderate-intensity behavioral exercise intervention (AE) Receives: Behavioral: Aerobic exercise |
| Health and Wellness | Active comparator | 12-week health and wellness education control (HEC) Receives: Behavioral: Health and Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology)
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ana M Abrantes, Ph.D., Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242735
- Sponsor's protocol ID
- 1006-001
- Other IDs
- 1R01MH086513-01A1
- Status last verified
- Jul 2015
- First submitted
- 16 Nov 2010
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Szuhany KL, Steinberg MH, McLaughlin NCR, Mancebo MC, Brown RA, Greenberg BD, Simon NM, Abrantes AM. Predictors of Long-Term Exercise Engagement in Patients With Obsessive-Compulsive Disorder: The Role of Physical Activity Enjoyment. Behav Ther. 2023 Jul;54(4):610-622. doi: 10.1016/j.beth.2022.12.010. Epub 2023 Jan 5.
PubMed 37330252
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of an Exercise Intervention for Patients With OCD
- ClinicalTrials.gov ID
- NCT01242735
- Acronym / sponsor ID
- 1006-001
- Conditions
- Obsessive Compulsive Disorder
- Keywords
- Obsessive Compulsive Disorder, OCD, Exercise, Aerobic Exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Nov 2010 (estimated)
- 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 purpose of this study is to test the effect of a moderate-intensity aerobic exercise intervention for Obsessive Compulsive Disorder (OCD) patients interested in reducing symptoms. The investigators expect that this project will contribute much needed knowledge about the role that aerobic exercise can play in managing the effects of OCD. If moderate-intensity aerobic exercise is efficacious in helping individuals with OCD manage obsessions and compulsions, this will establish that aerobic exercise may be a valuable adjunct to other OCD treatments such as medication and therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Aerobic exercise12-week moderate-intensity behavioral exercise intervention (AE) |
| Health and Wellness | Active comparator | Behavioral: Health and Wellness12-week health and wellness education control (HEC) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- are between 18 and 65 years of age
- are sedentary, i.e. have not participated in regular aerobic physical exercise for at least 90 minutes per week during the past three months
- currently engaged in at least 12 weeks of stable dose pharmacotherapy and/or are currently engaged in cognitive-behavioral therapy for the past 13 weeks
- meet Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) criteria for OCD as assessed by the Structured Clinical Interview for DSM Disorders, Patient Version (SCID-P)
- have Y-BOCS score greater than 16
Key exclusion criteria (8 listed)
- DSM-IV diagnosis of substance abuse/dependence except for nicotine dependence
- DSM-IV diagnosis of anorexia or bulimia nervosa
- DSM-IV diagnosis of bipolar disorder
- history of psychotic disorder or current psychotic symptoms
- current suicidality or homicidality
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 |
|---|---|---|
| Aerobic exercise12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals. | Behavioural | Exercise |
| Health and Wellness12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert. | Behavioural | Health and Wellness |
Primary outcome
Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology)
Time frame: 15 months
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 22 Jul 2015.
- Derived from this study: PubMed 37330252Szuhany KL, Steinberg MH, McLaughlin NCR, Mancebo MC, Brown RA, Greenberg BD, Simon NM, Abrantes AM. Predictors of Long-Term Exercise Engagement in Patients With Obsessive-Compulsive Disorder: The Role of Physical Activity Enjoyment. Behav Ther. 2023 Jul;54(4):610-622. doi: 10.1016/j.beth.2022.12.010. Epub 2023 Jan 5.
Related trials for Obsessive Compulsive Disorder
Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
Obsessive - Compulsive Disorder, Family Accommodation
Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
Precision Analytic Research Methods in OCD
Obsessive Compulsive Disorder
Recruiting
Focused Ultrasound for Behavioral Health
Depression, Anxiety
Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
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.
Ana M Abrantes, Ph.D. principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerobic exercise and Health and Wellness in people with Obsessive Compulsive Disorder, run by Butler Hospital 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 5 inclusion and 8 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 22 Jul 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Yale-Brown Obsessive Compulsive Scale (Y-BOCS; OCD symptomatology) (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01242735, which also lists 1 linked publication.
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 22 Jul 2015.