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Clinical Trials/NCT05964998
NCT05964998
Withdrawn
N/A

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

Rogers Behavioral Health1 site in 1 country20 target enrollmentMarch 18, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obsessive-Compulsive Disorder
Sponsor
Rogers Behavioral Health
Enrollment
20
Locations
1
Primary Endpoint
Change in Quick Inventory of Depressive Symptomology from admission to discharge
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2024
End Date
December 11, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Quick Inventory of Depressive Symptomology from admission to discharge

Time Frame: Up to 12 weeks

Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge

Time Frame: Up to 12 weeks

Secondary Outcomes

  • 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)

Study Sites (1)

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