Clinical trial NCT02329587: Transcranial Direct Current Stimulation Augmented Exposure and Response Prevention for Obsessive-Compulsive Disorder
Official title: tDCS for Inhibitory Control Deficits: A Test in OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-12-31
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score
timeFrame: Post-treatment (approximately 6.5 weeks post-baseline)
measure: Client Satisfaction Questionnaire-8: Total Score
timeFrame: Post-treatment (approximately 6.5 weeks post-baseline)
measure: Rates of Session Completion
timeFrame: Approximately 6.5 weeks post-baseline
Secondary outcomes:
measure: Yale-Brown Obsessive-Compulsive Scale: Total Score
timeFrame: 1-month follow up (Approximately 11 weeks after baseline assessment)
measure: Client Satisfaction Questionnaire-8: Total Score
timeFrame: 1-month follow up (Approximately 11 weeks after baseline assessment)
measure: Rates of Retention in Intervention
timeFrame: Approximately 6.5 weeks post-baseline
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Benjamin Greenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Butler Hospital
name: Sarah Garnaat, PhD
role: PRINCIPAL_INVESTIGATOR
References: