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

Sponsor

Rogers Behavioral Health (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05964998

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obsessive-Compulsive Disorder	Device: transcranial direct current stimulation Device: Sham transcranial direct current stimulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants randomized to either active tDCS stimulation or sham.Participants randomized to either active tDCS stimulation or sham.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Active stimulation

Device: transcranial direct current stimulation

Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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