N/A
N=12
Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder
Obsessive-Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02329587 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score — 15.5; 16.33 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ERP plus tDCS (Other); ERP plus sham tDCS (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Butler Hospital
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score |
15.5; 16.33 | — |
| PRIMARY Client Satisfaction Questionnaire-8: Total Score |
30.75; 28.00 | — |
| PRIMARY Rates of Session Completion |
8.40; 8.43 | — |
| SECONDARY Yale-Brown Obsessive-Compulsive Scale: Total Score |
17.25; 16.20 | — |
| SECONDARY Client Satisfaction Questionnaire-8: Total Score |
30.75; 28.00 | — |
| SECONDARY Rates of Retention in Intervention |
3; 4 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02329587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.