Back to resultsPilot Study of CBT With tDCS for Adults Being Treated for Obsessive Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sham transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Obsessive-Compulsive Disorder, OCD, transcranial direct current stimulation, tDCS, Cognitive Behavior Therapy, CBT
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
Sites / Locations
- Rogers Behavioral Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active stimulation
Sham stimulation
Arm Description
Outcomes
Primary Outcome Measures
Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge
Change in Quick Inventory of Depressive Symptomology from admission to discharge
Secondary Outcome Measures
Number of treatment days between admission and discharge
Change in Obsessive-Compulsive Inventory-Revised from admission to discharge
Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge
Change in Intolerance of uncertainty scale from admission to discharge
Change in Subjective units of distress from admission to discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05964998
Brief Title
Pilot Study of CBT With tDCS for Adults Being Treated for Obsessive Compulsive Disorder
Official Title
Investigating Non-invasive Brain Stimulation to Enhance CBT in Intensive Treatment-seeking Patients With OCD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rogers Behavioral Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Obsessive-Compulsive Disorder, OCD, transcranial direct current stimulation, tDCS, Cognitive Behavior Therapy, CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomized to either active tDCS stimulation or sham.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active stimulation
Arm Type
Experimental
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Description
Current will increase to 1.5 milliamps within 30 seconds and then maintain for 20 minutes
Intervention Type
Device
Intervention Name(s)
Sham transcranial direct current stimulation
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Yale-Brown Obsessive-Compulsive Scale - Self-Report from admission to discharge
Time Frame
Up to 12 weeks
Title
Change in Quick Inventory of Depressive Symptomology from admission to discharge
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Number of treatment days between admission and discharge
Time Frame
Up to 12 weeks
Title
Change in Obsessive-Compulsive Inventory-Revised from admission to discharge
Time Frame
Up to 12 weeks
Title
Change in Quality of life enjoyment and satisfaction questionnaire - short form from admission to discharge
Time Frame
Up to 12 weeks
Title
Change in Intolerance of uncertainty scale from admission to discharge
Time Frame
Up to 12 weeks
Title
Change in Subjective units of distress from admission to discharge
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey M Engelmann, PhD
Phone
262-646-1851
Email
jeff.engelmann@rogersbh.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bradley C Riemann, PhD
Phone
262-646-1388
Email
bradley.riemann@rogersbh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley C Riemann, PhD
Organizational Affiliation
Rogers Behavioral Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rogers Behavioral Health
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey M Engelmann, PhD
Phone
262-646-1851
Email
jeff.engelmann@rogersbh.org
First Name & Middle Initial & Last Name & Degree
Bradley C Riemann, PhD
First Name & Middle Initial & Last Name & Degree
Jeffrey M Engelmann, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of CBT With tDCS for Adults Being Treated for Obsessive Compulsive Disorder
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