Obsessive Compulsive Disorder (OCD)Phase 1NCT06840951
Priming CBT With rTMS for OCD
A Phase 1 study testing rTMS and CBT in people with Obsessive Compulsive Disorder (OCD), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Cognitive behavioural therapy (CBT), incorporating exposure/response prevention (ERP) and cognitive therapy, is considered the gold-standard first-line treatment for obsessive-compulsive disorder (OCD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- rTMS and CBT
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 5 Feb 2025to Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- between the ages of 18-65
- experiencing clinically significant obsessive-compulsive symptoms based on the Yale-Brown Obsessive Compulsive Scale (YBOCS; score > 16)
- 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 8 weeks) prior to the initiation of the study
Who cannot join
- concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence
- suspected organic pathology
- an active comorbid medical condition that may require urgent intervention during the treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Priming Cognitive Flexibility With rTMS to Enhance CBT for OCD: A Pilot Study
Cognitive behavioural therapy (CBT), incorporating exposure/response prevention (ERP) and cognitive therapy, is considered the gold-standard first-line treatment for obsessive-compulsive disorder (OCD). Because CBT is a psychological treatment that aims to change patterns of thinking and behaving, it may be that improvement in cognitive functioning before treatment starts could lead CBT to be even more effective. One area of research that has shown potential benefit for OCD sufferers is rTMS. rTMS is a non-invasive procedure that uses pulses of energy to stimulate regions of the brain. Brief treatment with rTMS has shown to improve attention, memory, and other aspects of cognitive functioning that may facilitate learning in CBT. The proposed study aims to provide a pilot test of the clinical effectiveness of adding brief rTMS prior to completing CBT for OCD. If rTMS can demonstrate enhancement of cognitive functioning, which in turn, can improve treatment response to CBT, then the findings could easily be translated into routine clinical care.
Read the detailed description
Obsessive-compulsive disorder (OCD) has a lifetime prevalence of close to three percent and is one of the leading causes of disability worldwide. In addition to being associated with significant functional impairment in daily living and quality of life, OCD has been associated with neurocognitive deficits. Meta-analyses have found that individuals with OCD tend to perform worse on measures of neurocognitive functioning, including aspects of memory and executive functioning, compared to healthy controls, and that symptom severity is associated with worse cognitive functioning. While effective treatments for symptoms of OCD have consistently been identified, research findings regarding the impact of these treatments on cognitive functions related to OCD have been mixed. In addition, cognitive behavioural therapy (CBT), which incorporates exposure/response prevention (ERP) and cognitive therapy, is considered the gold-standard treatment for OCD. However, a substantial proportion of clients fail to respond to the treatment, and the majority of treatment responders still continue to report impairing levels of symptoms. A possible novel therapeutic approach is the use of repetitive transcranial magnetic stimulation (rTMS), a non-invasive procedure that uses electromagnetic field pulses to stimulate regions of the brain. rTMS can induce excitatory and inhibitory neural activity in the neural circuits of the motor cortex. In OCD, rTMS has shown a moderate therapeutic effect on obsessive-compulsive disorder symptom severity with response rates surpassing those of sham conditions, and has shown to lead to significant improvements in cognitive functions such as working memory, executive functioning, and attention. There is emergent empirical literature supporting the synergistic effects of rTMS with CBT in a range of psychiatric conditions although this has yet to be tested directly in OCD.
The proposed study aims to provide a pilot, proof of principle test of the clinical efficacy and treatment mechanisms of adding brief rTMS prior to completing CBT for OCD for patient participants with DSM-5 diagnosed OCD. It also aims to provide a preliminary examination of the extent to which rTMS leads to neuropsychological improvement and the extent to which cognitive improvement relates to improved CBT treatment response. The primary goals are to compare the relative efficacy of rTMS plus CBT to CBT alone at reducing OCD symptoms, and to examine the extent to which neuropsychological change on measures of attention, memory, and executive functioning during rTMS relate to subsequent treatment success with CBT. Treatment outcomes will be assessed using standardized measures of OCD symptoms, as well as measures of mood, anxiety, and wellbeing. If this pilot study can demonstrate that a brief rTMS intervention of 10 sessions over a two-week period can confer significant clinical gains for those suffering with OCD through neuropsychological improvement and that these improvements, in turn, can enhance the effectiveness of CBT, then it could easily be translated into highly accessible, routine clinical care. Further, demonstration of improvement in OCD-associated neurophysiological dysfunction, given the refractory nature of the illness, would provide another avenue into the long-term enhancement of outcomes for this chronically affected population. Results will also add to our understanding of the role of psychological mechanisms in the pathogenesis and treatment response in OCD.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- rTMS, CBT
- Keywords
- Obsessive compulsive disorder, Repetitive transcranial magnetic stimulation, Cognitive behavioural therapy, Flexibility, Neuroplasticity, Neurocognition
- 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.
rTMSDevice
Also called Repetitive transcranial magnetic stimulation
rTMS is a non-invasive procedure that uses electromagnetic field pulses to stimulate regions of the brain. rTMS can induce excitatory and inhibitory neural activity in the neural circuits of the motor cortex.
CBTBehavioural
Also called Cognitive behavioural therapy
CBT for OCD is a structured, short-term, present-oriented therapy with an emphasis on problem-solving and the modification of dysfunctional thinking and behaviour. CBT will be conducted in a group setting 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 with step-by-step strategies.
| Study group | Role | What they receive |
|---|---|---|
| Brief rTMS + Group CBT | Experimental | Participants in this study arm will receive 10 sessions of rTMS treatment Monday through Friday for two weeks. Following rTMS treatment, participants will receive 12 weeks of CBT. Receives: Device: rTMS; Behavioral: CBT |
| Group CBT only | Active comparator | Participants in this study arm will receive 12 weeks of CBT Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OCD symptom severity (Yale-Brown Obsessive Compulsive Scale; Y-BOCS)
The Y-BOCS 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 Y-BOCS have been shown to possess high internal consistency and validity.
Measured: From baseline to post-CBT treatment, up to 19 weeks
Secondary outcomes (5)
Change in OCD symptom type (Obsessive Compulsive Inventory - Revised; OCI-R)
The OCI-R is a self -report short version of the OCI consisting of 18 items measuring six distinct factors: Washing, Checking, Ordering, Obsessing, Hoarding and Neutralizing. The items measuring Hoarding will not be analyzed based on the separation of OCD and hoarding disorder in the DSM-5. The OCI-R has been found to be a psychometrically sound and valid measure of OCD and its various symptom presentations.
Measured: From baseline to post-CBT treatment, up to 19 weeks
Change in the experience of depression, anxiety, and stress symptoms (The Depression Anxiety Stress Scale - 21; DASS-21)
The DASS-21 is a self-report questionnaire comprising three subscales with seven items each for depression, anxiety and stress. The DASS-21 shows high internal consistency, high reliability in distinguishing between depression, anxiety and stress in adults, and good convergent and discriminant validity.
Measured: From baseline to post-CBT treatment, up to 19 weeks
Change in various attitudes and beliefs related to obsessional thoughts (The Obsessional Beliefs Questionnaire; OBQ-44)
The OBQ-44 is a 44-item self-report questionnaire designed to assess the extent to which respondents agree or disagree with various attitudes and beliefs related to obsessional thoughts. The OBQ is internally consistent, and evidences good test-retest reliability, convergent validity, and discriminant validity.
Measured: From baseline to post-CBT treatment, up to 19 weeks
Change in functional health and wellbeing (The Short Form 36-item Health Survey; SF-36)
The SF-36 Health Survey is a brief questionnaire containing 36 items about functional health and well-being. The reliability and validity of the SF-36 have been well documented. It has demonstrated good treatment sensitivity.
Measured: From baseline to post-CBT treatment, up to 19 weeks
Change in the degree at which individuals find distress intolerable (The Distress Tolerance Scale; DTS)
The DTS is a 15-item self-report questionnaire that measures the degree to which individuals find distress intolerable, unacceptable, impairing, and necessary to avoid. The DTS has demonstrated strong psychometric properties.
Measured: From baseline to post-CBT treatment, up to 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start5 Feb 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Treatment-seeking participants at Sunnybrook Health Sciences Centre (SHSC) with a primary DSM-5 diagnosis of OCD (N = 10) will receive 10 sessions of rTMS followed by 12 weekly sessions of group CBT. All participants will complete repeated assessments at baseline, at the end of the rTMS (Session 10) treatment, and four times throughout the CBT treatment at weeks 1, 4, 8, and 12.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil A. Rector, Ph.D., Principal investigator, Sunnybrook Health Sciences CentrePeter Giacobbe, M.D., Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840951
- Sponsor's protocol ID
- 6236
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priming Cognitive Flexibility With rTMS to Enhance CBT for OCD: A Pilot Study
- ClinicalTrials.gov ID
- NCT06840951
- Acronym / sponsor ID
- 6236
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Obsessive compulsive disorder, Repetitive transcranial magnetic stimulation, Cognitive behavioural therapy, Flexibility, Neuroplasticity, Neurocognition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 Feb 2025 (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.
Cognitive behavioural therapy (CBT), incorporating exposure/response prevention (ERP) and cognitive therapy, is considered the gold-standard first-line treatment for obsessive-compulsive disorder (OCD). Because CBT is a psychological treatment that aims to change patterns of thinking and behaving, it may be that improvement in cognitive functioning before treatment starts could lead CBT to be even more effective. One area of research that has shown potential benefit for OCD sufferers is rTMS. rTMS is a non-invasive procedure that uses pulses of energy to stimulate regions of the brain. Brief treatment with rTMS has shown to improve attention, memory, and other aspects of cognitive functioning that may facilitate learning in CBT. The proposed study aims to provide a pilot test of the clinical effectiveness of adding brief rTMS prior to completing CBT for OCD. If rTMS can demonstrate enhancement of cognitive functioning, which in turn, can improve treatment response to CBT, then the findings could easily be translated into routine clinical care.
Detailed description
Obsessive-compulsive disorder (OCD) has a lifetime prevalence of close to three percent and is one of the leading causes of disability worldwide. In addition to being associated with significant functional impairment in daily living and quality of life, OCD has been associated with neurocognitive deficits. Meta-analyses have found that individuals with OCD tend to perform worse on measures of neurocognitive functioning, including aspects of memory and executive functioning, compared to healthy controls, and that symptom severity is associated with worse cognitive functioning. While effective treatments for symptoms of OCD have consistently been identified, research findings regarding the impact of these treatments on cognitive functions related to OCD have been mixed. In addition, cognitive behavioural therapy (CBT), which incorporates exposure/response prevention (ERP) and cognitive therapy, is considered the gold-standard treatment for OCD. However, a substantial proportion of clients fail to respond to the treatment, and the majority of treatment responders still continue to report impairing levels of symptoms. A possible novel therapeutic approach is the use of repetitive transcranial magnetic stimulation (rTMS), a non-invasive procedure that uses electromagnetic field pulses to stimulate regions of the brain. rTMS can induce excitatory and inhibitory neural activity in the neural circuits of the motor cortex. In OCD, rTMS has shown a moderate therapeutic effect on obsessive-compulsive disorder symptom severity with response rates surpassing those of sham conditions, and has shown to lead to significant improvements in cognitive functions such as working memory, executive functioning, and attention. There is emergent empirical literature supporting the synergistic effects of rTMS with CBT in a range of psychiatric conditions although this has yet to be tested directly in OCD.
The proposed study aims to provide a pilot, proof of principle test of the clinical efficacy and treatment mechanisms of adding brief rTMS prior to completing CBT for OCD for patient participants with DSM-5 diagnosed OCD. It also aims to provide a preliminary examination of the extent to which rTMS leads to neuropsychological improvement and the extent to which cognitive improvement relates to improved CBT treatment response. The primary goals are to compare the relative efficacy of rTMS plus CBT to CBT alone at reducing OCD symptoms, and to examine the extent to which neuropsychological change on measures of attention, memory, and executive functioning during rTMS relate to subsequent treatment success with CBT. Treatment outcomes will be assessed using standardized measures of OCD symptoms, as well as measures of mood, anxiety, and wellbeing. If this pilot study can demonstrate that a brief rTMS intervention of 10 sessions over a two-week period can confer significant clinical gains for those suffering with OCD through neuropsychological improvement and that these improvements, in turn, can enhance the effectiveness of CBT, then it could easily be translated into highly accessible, routine clinical care. Further, demonstration of improvement in OCD-associated neurophysiological dysfunction, given the refractory nature of the illness, would provide another avenue into the long-term enhancement of outcomes for this chronically affected population. Results will also add to our understanding of the role of psychological mechanisms in the pathogenesis and treatment response in OCD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment-seeking participants at Sunnybrook Health Sciences Centre (SHSC) with a primary DSM-5 diagnosis of OCD (N = 10) will receive 10 sessions of rTMS followed by 12 weekly sessions of group CBT. All participants will complete repeated assessments at baseline, at the end of the rTMS (Session 10) treatment, and four times throughout the CBT treatment at weeks 1, 4, 8, and 12.
| Arm | Type | Receives |
|---|---|---|
| Brief rTMS + Group CBT | Experimental | Device: rTMS, Behavioral: CBTParticipants in this study arm will receive 10 sessions of rTMS treatment Monday through Friday for two weeks. Following rTMS treatment, participants will receive 12 weeks of CBT. |
| Group CBT only | Active comparator | Behavioral: CBTParticipants in this study arm will receive 12 weeks of CBT |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between the ages of 18-65
- experiencing clinically significant obsessive-compulsive symptoms based on the Yale-Brown Obsessive Compulsive Scale (YBOCS; score > 16)
- 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 8 weeks) prior to the initiation of the study
Key exclusion criteria (3 listed)
- concurrent diagnosis of a severe mood disorder, schizophrenia or other psychotic disorders, or substance abuse/dependence
- suspected organic pathology
- an 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 |
|---|---|---|
| rTMSAlso: Repetitive transcranial magnetic stimulationrTMS is a non-invasive procedure that uses electromagnetic field pulses to stimulate regions of the brain. rTMS can induce excitatory and inhibitory neural activity in the neural circuits of the motor cortex. | Device | Brief rTMS + Group CBT |
| CBTAlso: Cognitive behavioural therapyCBT for OCD is a structured, short-term, present-oriented therapy with an emphasis on problem-solving and the modification of dysfunctional thinking and behaviour. CBT will be conducted in a group setting 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 with step-by-step strategies. | Behavioural | Brief rTMS + Group CBT, Group CBT only |
Primary outcome
Change in OCD symptom severity (Yale-Brown Obsessive Compulsive Scale; Y-BOCS)
Time frame: From baseline to post-CBT treatment, up to 19 weeks
The Y-BOCS 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 Y-BOCS have been shown to possess high internal consistency and validity.
5 secondary outcomes
Change in OCD symptom type (Obsessive Compulsive Inventory - Revised; OCI-R)
Time frame: From baseline to post-CBT treatment, up to 19 weeks
Change in the experience of depression, anxiety, and stress symptoms (The Depression Anxiety Stress Scale - 21; DASS-21)
Time frame: From baseline to post-CBT treatment, up to 19 weeks
Change in various attitudes and beliefs related to obsessional thoughts (The Obsessional Beliefs Questionnaire; OBQ-44)
Time frame: From baseline to post-CBT treatment, up to 19 weeks
Change in functional health and wellbeing (The Short Form 36-item Health Survey; SF-36)
Time frame: From baseline to post-CBT treatment, up to 19 weeks
Change in the degree at which individuals find distress intolerable (The Distress Tolerance Scale; DTS)
Time frame: From baseline to post-CBT treatment, up to 19 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
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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.
Neil A. Rector, Ph.D. principal investigator
Sunnybrook Health Sciences Centre
Peter Giacobbe, M.D. principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rTMS and CBT in people with Obsessive Compulsive Disorder (OCD), run by Sunnybrook Health Sciences Centre at 1 site 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 OCD symptom severity (Yale-Brown Obsessive Compulsive Scale; Y-BOCS) (time frame: From baseline to post-CBT treatment, up to 19 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 Mar 2026.