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

Not Applicable
Completed
Conditions
Obsessive-Compulsive Disorder
Interventions
Other: ERP plus tDCS
Other: ERP plus sham tDCS
Registration Number
NCT02329587
Lead Sponsor
Butler Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
13
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ERP plus tDCSERP plus tDCSERP plus anodal tDCS of right inferior frontal gyrus
ERP plus sham tDCSERP plus sham tDCSERP plus sham tDCS of right inferior frontal gyrus
Primary Outcome Measures
NameTimeMethod
Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total ScorePost-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.

Client Satisfaction Questionnaire-8: Total ScorePost-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.

Rates of Session CompletionApproximately 6.5 weeks post-baseline

Average number of intervention sessions completed

Secondary Outcome Measures
NameTimeMethod
Yale-Brown Obsessive-Compulsive Scale: Total Score1-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.

Client Satisfaction Questionnaire-8: Total Score1-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.

Rates of Retention in InterventionApproximately 6.5 weeks post-baseline

Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.

Trial Locations

Locations (1)

Butler Hospital

🇺🇸

Providence, Rhode Island, United States

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