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Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ERP plus tDCS
ERP plus sham tDCS
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Current primary OCD diagnosis and current Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score of ≥16
  • 18-65 years of age
  • Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
  • Right-handed
  • No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry. Psychiatric medications will be limited to the following: serotonin reuptake inhibitors (SRI; including clomipramine), combination antidepressants (including bupropion and serotonin-norepinephrine reuptake inhibitors), buspirone, benzodiazepines, and/or stimulants
  • Naive to tDCS

Exclusion Criteria:

  • Active substance use disorder
  • Lifetime diagnosis of psychotic or bipolar mood disorder
  • Previous minimally adequate trial of ERP (e.g., at least 16 sessions including both therapist and self-directed exposure and response prevention)
  • Therapy outside the study protocol which has evidence for efficacy with OCD during the study intervention period
  • Active suicidal or homicidal ideation
  • Organic brain disease or injury
  • Any health problems that would interfere with study participation, including contraindications to tDCS (e.g., skin condition, mental implant in skull)
  • Women who are pregnant or breastfeeding. All women participants of child-bearing age are required to have a negative pregnancy test prior to treatment, and must use medically acceptable birth control during study participation. Medically acceptable birth control includes: established oral, injected, implanted, or vaginal ring hormonal contraception, an intrauterine device (IUD), two barrier contraception methods (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), or having a vasectomized partner
  • Use of anticonvulsant medications (including depakote, gabapentin, tegretol, dilantin, lamictal) and/or glutamate-acting agents (including n-acetylcysteine, riluzole, amantadine, memantine).

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ERP plus tDCS

ERP plus sham tDCS

Arm Description

ERP plus anodal tDCS of right inferior frontal gyrus

ERP plus sham tDCS of right inferior frontal gyrus

Outcomes

Primary Outcome Measures

Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score
The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.
Client Satisfaction Questionnaire-8: Total Score
The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.
Rates of Session Completion
Average number of intervention sessions completed

Secondary Outcome Measures

Yale-Brown Obsessive-Compulsive Scale: Total Score
The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.
Client Satisfaction Questionnaire-8: Total Score
The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.
Rates of Retention in Intervention
Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.

Full Information

First Posted
December 29, 2014
Last Updated
April 16, 2018
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02329587
Brief Title
Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder
Official Title
tDCS for Inhibitory Control Deficits: A Test in OCD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is investigating whether combining noninvasive brain stimulation with behavior therapy can help to improve outcomes for obsessive-compulsive disorder (OCD). Exposure and response prevention (ERP) -- a specific type of behavior therapy -- is a first line treatment for OCD. This study will test whether a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS), can help ERP work better.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERP plus tDCS
Arm Type
Experimental
Arm Description
ERP plus anodal tDCS of right inferior frontal gyrus
Arm Title
ERP plus sham tDCS
Arm Type
Active Comparator
Arm Description
ERP plus sham tDCS of right inferior frontal gyrus
Intervention Type
Other
Intervention Name(s)
ERP plus tDCS
Intervention Description
Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Intervention Type
Other
Intervention Name(s)
ERP plus sham tDCS
Intervention Description
Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
Primary Outcome Measure Information:
Title
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score
Description
The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.
Time Frame
Post-treatment (approximately 6.5 weeks post-baseline)
Title
Client Satisfaction Questionnaire-8: Total Score
Description
The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.
Time Frame
Post-treatment (approximately 6.5 weeks post-baseline)
Title
Rates of Session Completion
Description
Average number of intervention sessions completed
Time Frame
Approximately 6.5 weeks post-baseline
Secondary Outcome Measure Information:
Title
Yale-Brown Obsessive-Compulsive Scale: Total Score
Description
The Y-BOCS is a well-known measure for assessing OCD symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms.
Time Frame
1-month follow up (Approximately 11 weeks after baseline assessment)
Title
Client Satisfaction Questionnaire-8: Total Score
Description
The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.
Time Frame
1-month follow up (Approximately 11 weeks after baseline assessment)
Title
Rates of Retention in Intervention
Description
Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.
Time Frame
Approximately 6.5 weeks post-baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Current primary OCD diagnosis and current Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score of ≥16 18-65 years of age Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent Right-handed No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry. Psychiatric medications will be limited to the following: serotonin reuptake inhibitors (SRI; including clomipramine), combination antidepressants (including bupropion and serotonin-norepinephrine reuptake inhibitors), buspirone, benzodiazepines, and/or stimulants Naive to tDCS Exclusion Criteria: Active substance use disorder Lifetime diagnosis of psychotic or bipolar mood disorder Previous minimally adequate trial of ERP (e.g., at least 16 sessions including both therapist and self-directed exposure and response prevention) Therapy outside the study protocol which has evidence for efficacy with OCD during the study intervention period Active suicidal or homicidal ideation Organic brain disease or injury Any health problems that would interfere with study participation, including contraindications to tDCS (e.g., skin condition, mental implant in skull) Women who are pregnant or breastfeeding. All women participants of child-bearing age are required to have a negative pregnancy test prior to treatment, and must use medically acceptable birth control during study participation. Medically acceptable birth control includes: established oral, injected, implanted, or vaginal ring hormonal contraception, an intrauterine device (IUD), two barrier contraception methods (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), or having a vasectomized partner Use of anticonvulsant medications (including depakote, gabapentin, tegretol, dilantin, lamictal) and/or glutamate-acting agents (including n-acetylcysteine, riluzole, amantadine, memantine).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Greenberg, MD, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Garnaat, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder

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