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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05964998
• Other study ID #: 22-ROGE-103
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Rogers Behavioral Health
• Contact: Jeffrey M Engelmann, PhD
• Phone: 262-646-1851
• Email: jeff.engelmann[@]rogersbh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• transcranial direct current stimulation
Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes
• 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

Locations

Country	Name	City	State
United States	Rogers Behavioral Health	Oconomowoc	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Rogers Behavioral Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge		Up to 12 weeks
Primary	Change in Quick Inventory of Depressive Symptomology from admission to discharge		Up to 12 weeks
Secondary	Number of treatment days between admission and discharge		Up to 12 weeks
Secondary	Change in Obsessive-Compulsive Inventory-Revised from admission to discharge		Up to 12 weeks
Secondary	Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge		Up to 12 weeks
Secondary	Change in Intolerance of uncertainty scale from admission to discharge		Up to 12 weeks
Secondary	Change in Subjective units of distress from admission to discharge		Up to 12 weeks