Obsessive-Compulsive DisorderNCT02329587

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

A study testing ERP plus tDCS in people with Obsessive-Compulsive Disorder, run by Butler Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obsessive-Compulsive Disorder
What is being tested?: ERP plus tDCS
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 13 participants
Where: 1 siteUnited States
Study dates: Jan 2015to Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Butler Hospital
Providence, Rhode Island, 02908

Other trials in United States

About this study

Official title: tDCS for Inhibitory Control Deficits: A Test in OCD

Conditions: Obsessive-Compulsive Disorder
Being tested: ERP plus tDCS, ERP plus sham tDCS
Medical subject headings: Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ERP plus tDCSOther
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 tDCSOther
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.

Study groups in NCT02329587
Study group	Role	What they receive
ERP plus tDCS	Experimental	ERP plus anodal tDCS of right inferior frontal gyrus Receives: Other: ERP plus tDCS
ERP plus sham tDCS	Active comparator	ERP plus sham tDCS of right inferior frontal gyrus Receives: Other: ERP plus sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Post-treatment (approximately 6.5 weeks post-baseline)
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.
Measured: Post-treatment (approximately 6.5 weeks post-baseline)
Rates of Session Completion
Average number of intervention sessions completed
Measured: Approximately 6.5 weeks post-baseline

Secondary outcomes (3)

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.
Measured: 1-month follow up (Approximately 11 weeks after baseline assessment)
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.
Measured: 1-month follow up (Approximately 11 weeks after baseline assessment)
Rates of Retention in Intervention
Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.
Measured: Approximately 6.5 weeks post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Feb 2017

First posted31 Dec 2014 (estimated)
Study startJan 2015
Primary completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02329587
Sponsor's protocol ID: 1405-003
Other IDs: 1R21MH104728-01
Status last verified: Apr 2018
First submitted: 29 Dec 2014
Last updated: 15 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Not yet recruiting
tDCS and Symptom Provocation in Treatment-Resistant OCD
Obsessive - Compulsive Disorder
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder

All Obsessive-Compulsive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: tDCS for Inhibitory Control Deficits: A Test in OCD
ClinicalTrials.gov ID: NCT02329587
Acronym / sponsor ID: 1405-003
Conditions: Obsessive-Compulsive Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Butler HospitalUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: Jan 2015
Primary completion: Feb 2017 (actual)
First posted: 31 Dec 2014 (estimated)
Results: Posted 15 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ERP plus tDCS	Experimental	Other: ERP plus tDCSERP plus anodal tDCS of right inferior frontal gyrus
ERP plus sham tDCS	Active comparator	Other: ERP plus sham tDCSERP plus sham tDCS of right inferior frontal gyrus

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ERP plus tDCSParticipants 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.	Other	ERP plus tDCS
ERP plus sham tDCSParticipants 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.	Other	ERP plus sham tDCS

Primary outcome

Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score
Time frame: Post-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 Score
Time frame: Post-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 Completion
Time frame: Approximately 6.5 weeks post-baseline
Average number of intervention sessions completed

3 secondary outcomes

Yale-Brown Obsessive-Compulsive Scale: Total Score
Time frame: 1-month follow up (Approximately 11 weeks after baseline assessment)
Client Satisfaction Questionnaire-8: Total Score
Time frame: 1-month follow up (Approximately 11 weeks after baseline assessment)
Rates of Retention in Intervention
Time frame: Approximately 6.5 weeks post-baseline

Results and safety

Results posted to the registry on 15 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ERP Plus tDCS	5	4
ERP Plus Sham tDCS	7	6

Primary outcome: Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score

Time frame: Post-treatment (approximately 6.5 weeks post-baseline). Mean (Standard Deviation). Unit: units on a scale

Measure	ERP Plus tDCS n = 4	ERP Plus Sham tDCS n = 6
Value	15.5 (8.50)	16.33 (3.78)

ERP Plus tDCS vs ERP Plus Sham tDCS: Between-group effect size (Hedge's g): 0.138

Population analysed: All participants with available data at the outcome timepoint

Primary outcome: Client Satisfaction Questionnaire-8: Total Score

Time frame: Post-treatment (approximately 6.5 weeks post-baseline). Mean (Standard Deviation). Unit: units on a scale

Measure	ERP Plus tDCS n = 4	ERP Plus Sham tDCS n = 5
Value	29.04 (2.76)	29.60 (2.51)

ERP Plus tDCS vs ERP Plus Sham tDCS: Between-group effect size (Hedge's g): -0.214

Population analysed: All participants with available data on outcome measure

Primary outcome: Rates of Session Completion

Time frame: Approximately 6.5 weeks post-baseline. Mean (Full Range). Unit: Sessions

Measure	ERP Plus tDCS n = 5	ERP Plus Sham tDCS n = 7
Value	8.40 (1 to 11)	8.43 (1 to 11)

ERP Plus tDCS vs ERP Plus Sham tDCS: Between-groups effect size (Hedge's g): -0.007

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ERP Plus tDCS	0 of 5 (0%)	4 of 5 (80%)	0 of 5
ERP Plus Sham tDCS	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obsessive-Compulsive Disorder

Not yet recruiting
Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)
Recruiting
tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder
Obsessive-Compulsive Disorder
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Not yet recruiting
tDCS and Symptom Provocation in Treatment-Resistant OCD
Obsessive - Compulsive Disorder
RecruitingPhase 2
SONATA Dose Duration LIFU for OCD
Obsessive - Compulsive Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Benjamin Greenberg, MD, PhD principal investigator

Butler Hospital

Sarah Garnaat, PhD principal investigator

Butler Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ERP plus tDCS in people with Obsessive-Compulsive Disorder, run by Butler Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score (time frame: Post-treatment (approximately 6.5 weeks post-baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02329587.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.