This study will test how people with OCD respond to a type of noninvasive brain stimulation, repetitive Transcranial Magnetic Stimulation (rTMS), when it is combined with psychotherapy. Participants will either engage in Exposure and Response Prevention (ERP) Therapy or supportive therapy (ST) while receiving rTMS. Biobehavioral data from wearable devices and smartphones will be collected to better predict treatment responses. Participants will also undergo repeat resting state functional Magnetic Resonance Imaging (rsfMRI) in order to assess neural predictors and mechanisms of treatment response.
Diagnosis of Obsessive-Compulsive Disorder (OCD) as determined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria.
Live in Southern California and be willing to attend in-person to receive repetitive Transcranial Magnetic Stimulation (rTMS) 5 times per week for 6 weeks.
Have completed a prior course of Exposure and Response Prevention (ERP) therapy (at least ten sessions)
Currently take or have previously tried Serotonin Reuptake Inhibitor (SRI) medication for OCD
Primary psychiatric diagnosis other than OCD
Active substance use disorder
Active suicidality
Active psychosis
Parallel
Repetitive Transcranial Magnetic Stimulation (rTMS)
DevicerTMS will be delivered with the MagPro X100 system equipped with a Cool-DB80 coil and a Localite neuronavigation system. Neuronavigation will be performed for anatomical landmarking and co-registration of the brain to Talairach stereotaxic space, with the co-registered coil vertex coordinate (x0, y+60, z+60) as performed in previously published work on dmPFC-rTMS and which represents \~25% of the nasion-inion distance. Posterior coil handle orientation will be used with stimulation parameters of 20Hz repetition rate, 2 second stimulation duration, 20 second inter-train interval, and 50 trains, for a total of 2000 pulses per day. Stimulation will be delivered at 100% of extensor hallucis longus muscle resting motor threshold (MT), as determined by the PI. rTMS will be delivered 5 days per week (Monday through Friday) for 6 weeks for a total of 30 treatment sessions, in keeping with established protocols. Trained research staff will perform daily rTMS treatments and monitor participants.
Supportive Therapy (ST)
BehavioralSupportive therapy (ST) is a nondirective "talk therapy" focused on enhancing coping skills, strengthening existing resources, and improving daily functioning. Core techniques will include active listening, encouragement, validation, reframing, clarification (summarizing and paraphrasing), and naming problems. Participants will receive two ST sessions per week during the 6-week rTMS course. General goals include using the therapeutic relationship to foster adaptation, improve self-esteem, and support overall well-being. Each session will last 53-60 minutes and take place concurrently with rTMS, with the participant remaining in the TMS treatment room throughout.
Exposure and Response Prevention (ERP) Therapy
BehavioralERP is a form of cognitive-behavioral therapy designed to reduce obsessive-compulsive symptoms by weakening the association between feared stimuli and maladaptive responses. It promotes the formation and recall of non-threatening associations to counter fear-based learning. The participant and therapist will collaboratively create a hierarchy of OCD triggers, rated using the Subjective Units of Distress Scale (SUDS). ERP will begin with exposures rated 4-7 on the SUDS, while participants refrain from engaging in compulsions. Each trigger will be repeated until the SUDS rating decreases by at least 50% before progressing to the next item. Between-session ERP homework will be assigned, and participants will be provided self-monitoring homework rating forms to complete for subsequent review with the therapist. Each ERP session will last 53-60 minutes and will be conducted concurrently with rTMS, with the participant remaining in the TMS treatment room throughout.
Yale-Brown Obsessive-Compulsive Scale (YBOCS) Score
The investigators will use the Yale-Brown Obsessive-Compulsive Scale (YBOCS), the gold standard measure of OCD severity, to assess symptom levels. The YBOCS scale assesses five domains of obsessive and compulsive symptoms, which are each scored on a four-point scale, with 0 being "no symptoms" and 4 being "extreme symptoms". Combined scores range from 0 (no symptoms) to 40 (severe symptoms). A trained clinician, blinded to participant treatment, will administer the YBOCS at study enrollment, weekly during rTMS, at study end, and at 2-month follow-up to determine rate of change of YBOCS score, overall change after treatment, and durability of change at follow-up. Greater decreases in YBOCS scores sustained over time represent a better outcome.
Resting state functional connectivity
Resting state BOLD-signal fluctuations between hypothesis-driven brain regions-dmPFC (defined as center of mass = MNI X 0, Y+38, Z+24 in MNI-152) and bilateral caudate nucleus (defined as MNI X -8, Y+14, Z+6 and X+6, Y+14, Z+8)-will allow for calculation of functional connectivity between regions. The investigators will calculate change in functional connectivity from baseline to post-treatment.
Recruitment rate
Recruitment rate will be calculated as the percentage of individuals enrolled in the study relative to total participants screened.
Adverse and serious adverse event rates
All adverse and serious adverse events will be recorded for each participant. Differences between treatment groups will be compared.
Study dropout rate
Rate of dropout from the study will be calculated for all treatment groups as number of individuals starting the study relative to those completing the study. Differences between groups will be compared.
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Adam Frank
Lead sponsor
University of Southern California
Sponsor institution
