- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329587
Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder
April 16, 2018 updated by: Butler Hospital
tDCS for Inhibitory Control Deficits: A Test in OCD
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Rhode Island
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Providence, Rhode Island, United States, 02908
- Butler Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ERP plus tDCS
ERP plus anodal tDCS of right inferior frontal gyrus
|
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.
|
Active Comparator: ERP plus sham tDCS
ERP plus sham tDCS of right inferior frontal gyrus
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score
Time Frame: Post-treatment (approximately 6.5 weeks post-baseline)
|
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.
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Post-treatment (approximately 6.5 weeks post-baseline)
|
Client Satisfaction Questionnaire-8: Total Score
Time Frame: Post-treatment (approximately 6.5 weeks post-baseline)
|
The Client Satisfaction Questionnaire-8 is measure of client satisfaction.
Scores can range from 8-32, with higher scores corresponding to greater satisfaction.
|
Post-treatment (approximately 6.5 weeks post-baseline)
|
Rates of Session Completion
Time Frame: Approximately 6.5 weeks post-baseline
|
Average number of intervention sessions completed
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Approximately 6.5 weeks post-baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale-Brown Obsessive-Compulsive Scale: Total Score
Time Frame: 1-month follow up (Approximately 11 weeks after baseline assessment)
|
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.
|
1-month follow up (Approximately 11 weeks after baseline assessment)
|
Client Satisfaction Questionnaire-8: Total Score
Time Frame: 1-month follow up (Approximately 11 weeks after baseline assessment)
|
The Client Satisfaction Questionnaire-8 is measure of client satisfaction.
Scores can range from 8-32, with higher scores corresponding to greater satisfaction.
|
1-month follow up (Approximately 11 weeks after baseline assessment)
|
Rates of Retention in Intervention
Time Frame: Approximately 6.5 weeks post-baseline
|
Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.
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Approximately 6.5 weeks post-baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Garnaat, PhD, Butler Hospital
- Principal Investigator: Benjamin Greenberg, MD, PhD, Butler Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
December 29, 2014
First Submitted That Met QC Criteria
December 29, 2014
First Posted (Estimate)
December 31, 2014
Study Record Updates
Last Update Posted (Actual)
May 15, 2018
Last Update Submitted That Met QC Criteria
April 16, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1405-003
- 1R21MH104728-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive-Compulsive Disorder
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Anne Katrine PagsbergCopenhagen Trial Unit, Center for Clinical Intervention Research; Danish Research...Active, not recruitingObsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceDenmark
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Baylor College of MedicineRecruitingObsessive-Compulsive Disorder | Cognitive Behavioral Therapy | Obsessive-Compulsive Disorder in Children | Obsessive-Compulsive Disorder in AdolescenceUnited States
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Stanford UniversityCompletedObsessive Compulsive DisorderUnited States
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NYU Langone HealthCompletedObsessive Compulsive DisorderUnited States
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Massachusetts General HospitalActive, not recruitingObsessive Compulsive DisorderUnited States
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Boston University Charles River CampusCompletedObsessive Compulsive DisorderUnited States
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Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive DisorderUnited States
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Karolinska InstitutetCompletedObsessive Compulsive DisorderSweden
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Roseli ShavittCompleted
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University of South FloridaMassachusetts General HospitalCompletedObsessive-compulsive DisorderUnited States
Clinical Trials on ERP plus tDCS
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Shanghai Mental Health CenterRecruitingObsessive-Compulsive DisorderChina
-
Utah State UniversityUniversity of North Carolina, Chapel Hill; International OCD FoundationCompletedObsessive-Compulsive DisorderUnited States
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First Affiliated Hospital of Zhejiang UniversityRecruiting
-
National Yang Ming UniversityUnknown
-
Kenneth M Peters, MDTerminatedPelvic Pain | Cystitis, InterstitialUnited States
-
Butler HospitalNational Institute of Mental Health (NIMH)CompletedObsessive Compulsive Disorder
-
Auxilium Vitae VolterraCompleted
-
Charite University, Berlin, GermanyCompletedSchizophrenia | Auditory Verbal HallucinationsGermany
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MetroHealth Medical CenterRecruitingStroke | Hemiplegia | Upper Extremity ParesisUnited States
-
Johns Hopkins UniversityWithdrawn