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

December 11, 2024 updated by: Rogers Behavioral Health

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Oconomowoc, Wisconsin, United States, 53066
        • Rogers Behavioral Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham stimulation
Device: Sham transcranial direct current stimulation
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
Experimental: Active stimulation
Device: transcranial direct current stimulation
Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rogers Behavioral Health

Investigators

  • Principal Investigator: Bradley C Riemann, PhD, Rogers Behavioral Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Actual)

December 11, 2024

Study Completion (Actual)

December 11, 2024

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

July 19, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-ROGE-103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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