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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

tDCS for Inhibitory Control Deficits: A Test in OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02329587
• Other study ID #: 1405-003
• Secondary ID: 1R21MH104728-01
• Status: Completed
• Phase: N/A
• Start date: January 2015

Study information

• Verified date: April 2018
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Other:
• ERP plus tDCS
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
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.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score	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.	Post-treatment (approximately 6.5 weeks post-baseline)
Primary	Client Satisfaction Questionnaire-8: Total Score	The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.	Post-treatment (approximately 6.5 weeks post-baseline)
Primary	Rates of Session Completion	Average number of intervention sessions completed	Approximately 6.5 weeks post-baseline
Secondary	Yale-Brown Obsessive-Compulsive Scale: Total Score	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.	1-month follow up (Approximately 11 weeks after baseline assessment)
Secondary	Client Satisfaction Questionnaire-8: Total Score	The Client Satisfaction Questionnaire-8 is measure of client satisfaction. Scores can range from 8-32, with higher scores corresponding to greater satisfaction.	1-month follow up (Approximately 11 weeks after baseline assessment)
Secondary	Rates of Retention in Intervention	Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.	Approximately 6.5 weeks post-baseline