Pilot Study of CBT With tDCS for Adults Being Treated for Obsessive Compulsive Disorder

Study Overview
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Brief Summary
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This pilot study aims to compare the effect of transcranial direct current stimulation (tDCS) versus sham stimulation, delivered immediately prior to cognitive-behavioral therapy (CBT) for obsessive-compulsive disorder (OCD), on patient-reported outcomes. The investigator hypothesize that patients who receive active stimulation will experience greater improvement in OCD symptoms than those who receive sham stimulation.

Official Title
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Investigating Non-invasive Brain Stimulation to Enhance CBT in Intensive Treatment-seeking Patients With OCD

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Device: transcranial direct current stimulation
* Device: Sham transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of Obsessive-Compulsive Disorder (OCD) Resident of state of Wisconsin Enrolled in OCD Intensive Outpatient Program (IOP) at Rogers Behavioral Health in Oconomowoc, WI Ability to communicate effectively using written and spoken English Exclusion Criteria: Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices/defibrillators, prostheses) Currently taking medication that reduces seizure threshold (e.g., clomipramine) Cranial pathologies (e.g., holes, plates) History of seizure or black-out concussion Pregnancy Previous treatment at Rogers Behavioral Health

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants randomized to either active tDCS stimulation or sham.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active stimulation<br> | Device: transcranial direct current stimulation<br>* Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes<br>|
| Sham Comparator: Sham stimulation<br> | Device: Sham transcranial direct current stimulation<br>* Current will increase up to 1.5 milliamps within 30 seconds and then decrease back down over the next 30 seconds to 0 milliamps; subjects will received 0 milliamps for 20 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge |  | Up to 12 weeks | 
| Change in Quick Inventory of Depressive Symptomology from admission to discharge |  | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment days between admission and discharge |  | Up to 12 weeks | 
| Change in Obsessive-Compulsive Inventory-Revised from admission to discharge |  | Up to 12 weeks | 
| Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge |  | Up to 12 weeks | 
| Change in Intolerance of uncertainty scale from admission to discharge |  | Up to 12 weeks | 
| Change in Subjective units of distress from admission to discharge |  | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obsessive-Compulsive Disorder, OCD, transcranial direct current stimulation, tDCS, Cognitive Behavior Therapy, CBT