NCT06840951

Brief 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). 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
1mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Feb 2025Jun 2026

Study Start

First participant enrolled

February 5, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 7, 2025

Last Update Submit

March 3, 2026

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

Obsessive compulsive disorderRepetitive transcranial magnetic stimulationCognitive behavioural therapyFlexibilityNeuroplasticityNeurocognition

Outcome Measures

Primary Outcomes (1)

  • 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.

    From baseline to post-CBT treatment, up to 19 weeks

Secondary Outcomes (5)

  • Change in OCD symptom type (Obsessive Compulsive Inventory - Revised; OCI-R)

    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)

    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)

    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)

    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)

    From baseline to post-CBT treatment, up to 19 weeks

Other Outcomes (7)

  • Change in performance of attention (CANTAB Motor Screening Task; MOT)

    From baseline to post-rTMS treatment, 2 weeks

  • Change in performance of sustained attention (CANTAB Rapid Visual Information Processing; RVP)

    From baseline to post-rTMS treatment, 2 weeks

  • Change in performance of executive function (CANTAB One Touch Stockings of Cambridge; OTS)

    From baseline to post-rTMS treatment, 2 weeks

  • +4 more other outcomes

Study Arms (2)

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.

Device: rTMSBehavioral: CBT

Group CBT only

ACTIVE COMPARATOR

Participants in this study arm will receive 12 weeks of CBT

Behavioral: CBT

Interventions

CBTBEHAVIORAL

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.

Also known as: Cognitive behavioural therapy
Brief rTMS + Group CBTGroup CBT only
rTMSDEVICE

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.

Also known as: Repetitive transcranial magnetic stimulation
Brief rTMS + Group CBT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Magnetic StimulationCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Neil A. Rector, Ph.D.

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Peter Giacobbe, M.D.

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2025

First Posted

February 21, 2025

Study Start

February 5, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 4, 2026

Record last verified: 2026-02

Locations

CA(1)