Obsessive-Compulsive DisorderNCT02136953
Physical Exercise in OCD: Treatment Efficacy, Additive Benefits to CBT, and Cognitive Correlates of Change
A study testing Exercise and Cognitive Behavioural Therapy (CBT) in people with Obsessive-Compulsive Disorder and Cognition Disorders, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
Trial summary
Obsessive compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting 2% of the population. Cognitive behavioural therapy (CBT) is considered first line psychological treatment for OCD, but there are a large number of treatment non-responders, and the majority of responders have residual… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Cognition Disorders
- What is being tested?
- Exercise and Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 3 sitesCanada
- Study dates
- May 2014to 30 Aug 2019
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presenting with DSM-5 diagnosed OCD
- Score of >16 on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
- A Physical Activity Readiness Questionnaire (PAR-Q) score of ≤1
- If on medications for OCD, must be stabilized, i.e. are currently receiving an adequate dose (equivalent of 40mg/day of fluoxetine) for an adequate duration (at least 12 weeks of treatment) prior to the initiation of the study
- Has physician letter of approval for safe participation in fitness assessment and exercise protocol
Who cannot join
- Previous course of CBT treatment (≥ 8 sessions) in past two years
- Engaging in an active exercise regimen (>2 days/wk of moderate-to-vigorous exercise training) at the time of recruitment
- Concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence
- Suspected organic pathology
- Active comorbid medical condition that may require urgent intervention during the treatment
- Incapable of providing informed consent
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St. Joseph's Healthcare Hamilton at McMaster University
Hamilton, Ontario, L8N 4A6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Centre for Addiction and Mental Health
Toronto, Ontario, M5T 1R8
About this study
Official title: An Examination of Structured Physical Exercise in OCD: Treatment Efficacy, Additive Benefits to CBT, and Cognitive Correlates of Change
Obsessive compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting 2% of the population. Cognitive behavioural therapy (CBT) is considered first line psychological treatment for OCD, but there are a large number of treatment non-responders, and the majority of responders have residual symptoms. Aerobic exercise has shown potential benefit for general mood and anxiety disorders, but has not been widely tested in OCD. This study will examine the additive benefits of a standard 12-week aerobic exercise program to a standard 12-week CBT protocol in the treatment of OCD. The study will test if Exercise+CBT results in significantly better clinical outcomes compared to either treatment alone or no treatment at all. Treatment outcomes will be assessed in relation to symptom and cognitive measures of clinical improvement.
Read the detailed description
This study aims to determine if a standard, evidence-based 12-week aerobic exercise program results in significant reduction of obsessive-compulsive symptom severity and associated cognitive dysfunction as a stand-alone intervention and when combined with the first-line psychological treatment, cognitive behavioural therapy (CBT). There are 3 broad aims to this study: 1) to compare the relative efficacy of Exercise, CBT, and their combination (CBT+Ex) versus a non-treatment waitlist control (WL), 2) to examine the extent to which neuropsychological features of OCD improve following treatments, and 3) to determine the extent to which the BDNF gene and protein are a) associated with learning and cognitive factors, and b) moderate symptom and cognitive change across treatments.
The study design allows for a novel, well-powered and potentially landmark study on the impact of exercise on obsessive-compulsive symptom severity and cognitive functioning in OCD, both as a stand-alone treatment and when augmenting CBT. If this study can demonstrate that a short aerobic exercise program of 12 weeks duration can confer significant clinical gains for those suffering with OCD, then it could easily be translated into highly accessible, routine clinical care. Further, demonstration of improvement in OCD-associated cognitive dysfunction, given the refractory nature of the illness, would provide another avenue into the long-term enhancement of outcomes for this chronically affected population.
- Conditions
- Obsessive-Compulsive Disorder, Cognition Disorders
- Being tested
- Exercise, Cognitive Behavioural Therapy (CBT)
- Keywords
- Obsessive-Compulsive Disorder, Exercise, Cognitive Behavior Therapy, Cognitive Behavioral Therapy, Treatment Efficacy, Brain-Derived Neurotrophic Factor
- Medical subject headings
- Obsessive-Compulsive Disorder, Cognition Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
12 weeks of structured aerobic exercise, 3 times a week, following a two-stage graduated regimen: 1) Initial stage (weeks 1-4): 40-60% intensity, 15-30 min duration (+ 5 min warm-up/cool-down), and 2) Improvement stage (weeks 5-12): 60-80% intensity, 30-45 min duration. Adherence measures include self-reported exercise session logs and weekly phone checks by research assistants.
Cognitive Behavioural Therapy (CBT)Behavioural
CBT will be delivered in group format, 2 hours per week, for 12 consecutive weeks with 8-10 participants per group and will be conducted according to a session-by-session treatment manual that incorporates Exposure and Response Prevention (ERP) in the early phases of treatment and then increases emphasis on cognitive approaches for obsessions and compulsions outlined in step-by-step strategies.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 12-weeks of structured, individual aerobic exercise, 3 times a week, increasing from 15-30 minutes to 30-40 minutes per session. Receives: Behavioral: Exercise |
| Cognitive Behavioural Therapy (CBT) | Active comparator | 12-weeks of manual-based group CBT, 2 hours per week, 8 participants per group. Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
| Exercise and CBT | Experimental | Combined 12-week Exercise program and CBT. Receives: Behavioral: Exercise; Behavioral: Cognitive Behavioural Therapy (CBT) |
| Waitlist Condition | No intervention | 12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
OCD symptom severity will be measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS).The YBOCS is a standardized rating scale measuring 10 items pertaining to obsessions and compulsions on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Both the self-report and clinician interview versions of the YBOCS have been shown to possess high internal consistency and validity.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
Change from baseline in cognitive domains sensitive to OCD, as measured by a targeted neuropsychological battery
We have included core paper-and-pencil and computerized tests, such as those from the Cambridge Neuropsychological Test Automated Battery (CANTAB), which tap separable cognitive domains that are sensitive to OCD. CANTAB measures are standardized and have been shown to discriminate amongst many neurological and psychiatric illnesses To avoid practice effects, measures were selected to have either alternate form or to be amenable to calculation of reliable change indices (RCIs). RCIs will be used to determine if neuropsychology performance scores change significantly over time.
Measured: Baseline 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 posted13 May 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2017
- Study completion30 Aug 2019
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 Sunnybrook Health Sciences CentreThe 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
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre for Addiction and Mental Health, McMaster University, Toronto Metropolitan University
- Responsible party
- Principal investigator, Dr. Neil Rector, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136953
- Sponsor's protocol ID
- MOP133452
- Status last verified
- Oct 2019
- First submitted
- 9 May 2014
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Structured Physical Exercise in OCD: Treatment Efficacy, Additive Benefits to CBT, and Cognitive Correlates of Change
- ClinicalTrials.gov ID
- NCT02136953
- Acronym / sponsor ID
- MOP133452
- Conditions
- Obsessive-Compulsive Disorder, Cognition Disorders
- Keywords
- Obsessive-Compulsive Disorder, Exercise, Cognitive Behavior Therapy, Cognitive Behavioral Therapy, Treatment Efficacy, Brain-Derived Neurotrophic Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Centre for Addiction and Mental Health, McMaster University, Toronto Metropolitan University
- Study start
- May 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 13 May 2014 (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.
Obsessive compulsive disorder (OCD) is a severe and debilitating anxiety disorder afflicting 2% of the population. Cognitive behavioural therapy (CBT) is considered first line psychological treatment for OCD, but there are a large number of treatment non-responders, and the majority of responders have residual symptoms. Aerobic exercise has shown potential benefit for general mood and anxiety disorders, but has not been widely tested in OCD. This study will examine the additive benefits of a standard 12-week aerobic exercise program to a standard 12-week CBT protocol in the treatment of OCD. The study will test if Exercise+CBT results in significantly better clinical outcomes compared to either treatment alone or no treatment at all. Treatment outcomes will be assessed in relation to symptom and cognitive measures of clinical improvement.
Detailed description
This study aims to determine if a standard, evidence-based 12-week aerobic exercise program results in significant reduction of obsessive-compulsive symptom severity and associated cognitive dysfunction as a stand-alone intervention and when combined with the first-line psychological treatment, cognitive behavioural therapy (CBT). There are 3 broad aims to this study: 1) to compare the relative efficacy of Exercise, CBT, and their combination (CBT+Ex) versus a non-treatment waitlist control (WL), 2) to examine the extent to which neuropsychological features of OCD improve following treatments, and 3) to determine the extent to which the BDNF gene and protein are a) associated with learning and cognitive factors, and b) moderate symptom and cognitive change across treatments.
The study design allows for a novel, well-powered and potentially landmark study on the impact of exercise on obsessive-compulsive symptom severity and cognitive functioning in OCD, both as a stand-alone treatment and when augmenting CBT. If this study can demonstrate that a short aerobic exercise program of 12 weeks duration can confer significant clinical gains for those suffering with OCD, then it could easily be translated into highly accessible, routine clinical care. Further, demonstration of improvement in OCD-associated cognitive dysfunction, given the refractory nature of the illness, would provide another avenue into the long-term enhancement of outcomes for this chronically affected population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise12-weeks of structured, individual aerobic exercise, 3 times a week, increasing from 15-30 minutes to 30-40 minutes per session. |
| Cognitive Behavioural Therapy (CBT) | Active comparator | Behavioral: Cognitive Behavioural Therapy (CBT)12-weeks of manual-based group CBT, 2 hours per week, 8 participants per group. |
| Exercise and CBT | Experimental | Behavioral: Exercise, Behavioral: Cognitive Behavioural Therapy (CBT)Combined 12-week Exercise program and CBT. |
| Waitlist Condition | No intervention | –12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presenting with DSM-5 diagnosed OCD
- Score of >16 on the Yale-Brown Obsessive Compulsive Scale (YBOCS)
- A Physical Activity Readiness Questionnaire (PAR-Q) score of ≤1
- If on medications for OCD, must be stabilized, i.e. are currently receiving an adequate dose (equivalent of 40mg/day of fluoxetine) for an adequate duration (at least 12 weeks of treatment) prior to the initiation of the study
- Has physician letter of approval for safe participation in fitness assessment and exercise protocol
Key exclusion criteria (6 listed)
- Previous course of CBT treatment (≥ 8 sessions) in past two years
- Engaging in an active exercise regimen (>2 days/wk of moderate-to-vigorous exercise training) at the time of recruitment
- Concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence
- Suspected organic pathology
- Active comorbid medical condition that may require urgent intervention during the treatment
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 |
|---|---|---|
| Exercise12 weeks of structured aerobic exercise, 3 times a week, following a two-stage graduated regimen: 1) Initial stage (weeks 1-4): 40-60% intensity, 15-30 min duration (+ 5 min warm-up/cool-down), and 2) Improvement stage (weeks 5-12): 60-80% intensity, 30-45 min duration. Adherence measures include self-reported exercise session logs and weekly phone checks by research assistants. | Behavioural | Exercise, Exercise and CBT |
| Cognitive Behavioural Therapy (CBT)CBT will be delivered in group format, 2 hours per week, for 12 consecutive weeks with 8-10 participants per group and will be conducted according to a session-by-session treatment manual that incorporates Exposure and Response Prevention (ERP) in the early phases of treatment and then increases emphasis on cognitive approaches for obsessions and compulsions outlined in step-by-step strategies. | Behavioural | Cognitive Behavioural Therapy (CBT), Exercise and CBT |
Primary outcome
Change from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
Time frame: Baseline and 12 weeks
OCD symptom severity will be measured using the Yale-Brown Obsessive Compulsive Scale (YBOCS).The YBOCS is a standardized rating scale measuring 10 items pertaining to obsessions and compulsions on a 5-point Likert scale ranging from 0 (no symptoms) to 4 (severe symptoms). Both the self-report and clinician interview versions of the YBOCS have been shown to possess high internal consistency and validity.
1 secondary outcome
Change from baseline in cognitive domains sensitive to OCD, as measured by a targeted neuropsychological battery
Time frame: Baseline 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 4 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Cognitive Behavioural Therapy (CBT) in people with Obsessive-Compulsive Disorder and Cognition Disorders, run by Sunnybrook Health Sciences Centre at 3 sites in Canada.
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 6 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 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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 from baseline in OCD symptom severity, as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS) (time frame: Baseline and 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 4 Oct 2019.