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

NCT02329587 | Completed Results DMC

• 2 other identifiers: 1405-0031R21MH104728-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-Compulsive Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  Post-treatment (approximately 6.5 weeks post-baseline)

• 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.

  Post-treatment (approximately 6.5 weeks post-baseline)

• Rates of Session Completion

  Average number of intervention sessions completed

  Approximately 6.5 weeks post-baseline

Secondary Outcomes (3)

• Yale-Brown Obsessive-Compulsive Scale: Total Score

  1-month follow up (Approximately 11 weeks after baseline assessment)

• Client Satisfaction Questionnaire-8: Total Score

  1-month follow up (Approximately 11 weeks after baseline assessment)

• Rates of Retention in Intervention

  Approximately 6.5 weeks post-baseline

Study Arms (2)

ERP plus tDCS

EXPERIMENTAL

ERP plus anodal tDCS of right inferior frontal gyrus

Other: ERP plus tDCS

ERP plus sham tDCS

ACTIVE COMPARATOR

ERP plus sham tDCS of right inferior frontal gyrus

Other: ERP plus sham tDCS

Interventions

ERP plus tDCS OTHER

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.

ERP plus tDCS

ERP plus sham tDCS OTHER

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.

ERP plus sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current primary OCD diagnosis and current Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) total score of ≥16
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02908, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Sarah Garnaat
• Organization: Butler Hospital

sgarnaat@butler.og

401-455-6659

Study Officials

• Benjamin Greenberg, MD, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

• Sarah Garnaat, PhD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: December 31, 2014
• Study Start: January 1, 2015
• Primary Completion: February 1, 2017
• Last Updated: May 15, 2018
• Results First Posted: May 15, 2018

Record last verified: 2018-04

Locations

US (1)