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

Not Applicable
Completed
Conditions
Obsessive-Compulsive Disorder
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
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

Butler Hospital
🇺🇸Providence, Rhode Island, United States

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