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

Not Applicable

Withdrawn

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Sham transcranial direct current stimulation; Device: transcranial direct current stimulation

• Registration Number: NCT05964998
• Lead Sponsor: Rogers Behavioral Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-07-19
• Study First Posted: 2023-07-28
• Study Start: 2024-03-18
• Status Verified: 2024-12
• Primary Completion: 2024-12-11
• Study Completion: 2024-12-11
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham stimulation	Sham transcranial direct current stimulation	-
Active stimulation	transcranial direct current stimulation	-

Primary Outcome Measures

Name	Time	Method
Change in Quick Inventory of Depressive Symptomology from admission to discharge	Up to 12 weeks
Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge	Up to 12 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rogers Behavioral Health; 🇺🇸 Oconomowoc, Wisconsin, United States