Skip to main content
OpenTrials
Completed

NCT Number: NCT02329587

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

  2. 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.

  3. Rates of Session Completion

    Time frame: Approximately 6.5 weeks post-baseline

    Average number of intervention sessions completed

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

tDCS for Inhibitory Control Deficits: A Test in OCD

Important dates

Study start
2015
Primary completion
2017
First posted
Dec 31, 2014
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.