Clinical trial NCT06840951: Priming CBT with RTMS for OCD
Official title: Priming Cognitive Flexibility with RTMS to Enhance CBT for OCD: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Obsessive Compulsive Disorder (OCD)
Keywords: Obsessive compulsive disorder
Repetitive transcranial magnetic stimulation
Cognitive behavioural therapy
Flexibility
Neuroplasticity
Neurocognition
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in OCD symptom severity (Yale-Brown Obsessive Compulsive Scale; Y-BOCS)
timeFrame: From baseline to post-CBT treatment, up to 19 weeks
Secondary outcomes:
measure: Change in OCD symptom type (Obsessive Compulsive Inventory - Revised; OCI-R)
timeFrame: From baseline to post-CBT treatment, up to 19 weeks
measure: Change in the experience of depression, anxiety, and stress symptoms (The Depression Anxiety Stress Scale - 21; DASS-21)
timeFrame: From baseline to post-CBT treatment, up to 19 weeks
measure: Change in various attitudes and beliefs related to obsessional thoughts (The Obsessional Beliefs Questionnaire; OBQ-44)
timeFrame: From baseline to post-CBT treatment, up to 19 weeks
measure: Change in functional health and wellbeing (The Short Form 36-item Health Survey; SF-36)
timeFrame: From baseline to post-CBT treatment, up to 19 weeks
measure: Change in the degree at which individuals find distress intolerable (The Distress Tolerance Scale; DTS)
timeFrame: From baseline to post-CBT treatment, up to 19 weeks
Other outcomes:
measure: Change in performance of attention (CANTAB Motor Screening Task; MOT)
timeFrame: From baseline to post-rTMS treatment, 2 weeks
measure: Change in performance of sustained attention (CANTAB Rapid Visual Information Processing; RVP)
timeFrame: From baseline to post-rTMS treatment, 2 weeks
measure: Change in performance of executive function (CANTAB One Touch Stockings of Cambridge; OTS)
timeFrame: From baseline to post-rTMS treatment, 2 weeks
measure: Change in performance of memory (CANTAB Verbal Recognition Memory task; VRM)
timeFrame: From baseline to post-rTMS treatment, 2 weeks
measure: Change in performance of non-verbal memory (CANTAB Delayed Matching to Sample task; DMS)
timeFrame: From baseline to post-rTMS treatment, 2 weeks
measure: Change in performance of non-verbal memory (CANTAB Paired Associates Learning task; PAL)
timeFrame: From baseline to post-rTMS treatment, 2 weeks
measure: Change in performance of social-emotional cognition (CANTAB Emotion Recognition Task; ERT)
timeFrame: From baseline to post-rTMS treatment, 2 weeks
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Neil A. Rector, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Peter Giacobbe, M.D.
role: PRINCIPAL_INVESTIGATOR
References: