Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5, Canada
NCT Number: NCT06840951
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.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Phase 1
Toronto, Ontario, M4N3M5, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Repetitive transcranial magnetic stimulation
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.
Other names: Cognitive behavioural therapy
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.
Time frame: From baseline to post-CBT treatment, up to 19 weeks
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.
Time frame: From baseline to post-CBT treatment, up to 19 weeks
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.
Time frame: From baseline to post-CBT treatment, up to 19 weeks
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.
Time frame: From baseline to post-CBT treatment, up to 19 weeks
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.
Time frame: From baseline to post-CBT treatment, up to 19 weeks
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.
Time frame: From baseline to post-rTMS treatment, 2 weeks
The MOT evaluates potential sensorimotor or comprehension deficits.
Time frame: From baseline to post-rTMS treatment, 2 weeks
The RVP measures sustained attention, latency, probability of false alarms, and sensitivity.
Time frame: From baseline to post-rTMS treatment, 2 weeks
The OTS measures the working memory and spatial planning subdomains of executive function.
Time frame: From baseline to post-rTMS treatment, 2 weeks
The VRM measures new learning and verbal memory through the ability of collecting verbal information and its retrieval.
Time frame: From baseline to post-rTMS treatment, 2 weeks
The DMS measures visual matching ability and short-term visual recognition memory.
Time frame: From baseline to post-rTMS treatment, 2 weeks
The PAL measures visual memory and new learning.
Time frame: From baseline to post-rTMS treatment, 2 weeks
The ERT measures the ability in identification of six basic human emotions in facial expression along that expression's magnitude spectrum.
Sunnybrook Health Sciences Centre
Other
Priming Cognitive Flexibility With rTMS to Enhance CBT for OCD: A Pilot Study
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