Obsessive-Compulsive Disorder
Conditions
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.
Interventions
OTHERERP 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.
OTHERERP 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.
Sponsors
National Institute of Mental Health (NIMH)
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score | 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 | 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 | Approximately 6.5 weeks post-baseline | Average number of intervention sessions completed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Yale-Brown Obsessive-Compulsive Scale: Total Score | 1-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 Score | 1-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 Intervention | Approximately 6.5 weeks post-baseline | Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions. |
Countries
United States
Participant flow
Pre-assignment details
A baseline assessment was completed between participant enrollment and randomization. Withdrawal during the baseline assessment could result in enrolled participants not being assigned to a treatment group.
Participants by arm
| Arm | Count |
|---|---|
| ERP Plus tDCS ERP plus anodal tDCS of right inferior frontal gyrus
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. | 5 |
| ERP Plus Sham tDCS ERP plus sham tDCS of right inferior frontal gyrus
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. | 7 |
| Total | 12 |
Baseline characteristics
| Characteristic | ERP Plus tDCS | Total | ERP Plus Sham tDCS |
|---|---|---|---|
| Age, Continuous | 38.00 years STANDARD_DEVIATION 17.42 | 39.08 years STANDARD_DEVIATION 13.47 | 39.86 years STANDARD_DEVIATION 11.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
| Yale-Brown Obsessive-Compulsive Scale (Y-BOCS): Total Score | 24.80 units on a scale STANDARD_DEVIATION 6.5 | 25.08 units on a scale STANDARD_DEVIATION 5.04 | 25.29 units on a scale STANDARD_DEVIATION 4.27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 7 |
| other Total, other adverse events | 4 / 5 | 5 / 7 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 |
Outcome results
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.
Time frame: Post-treatment (approximately 6.5 weeks post-baseline)
Population: All participants with available data on outcome measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERP Plus tDCS | Client Satisfaction Questionnaire-8: Total Score | 29.04 units on a scale | Standard Deviation 2.76 |
| ERP Plus Sham tDCS | Client Satisfaction Questionnaire-8: Total Score | 29.60 units on a scale | Standard Deviation 2.51 |
Primary
Rates of Session Completion
Average number of intervention sessions completed
Time frame: Approximately 6.5 weeks post-baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ERP Plus tDCS | Rates of Session Completion | 8.40 Sessions |
| ERP Plus Sham tDCS | Rates of Session Completion | 8.43 Sessions |
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.
Time frame: Post-treatment (approximately 6.5 weeks post-baseline)
Population: All participants with available data at the outcome timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERP Plus tDCS | Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score | 15.5 units on a scale | Standard Deviation 8.5 |
| ERP Plus Sham tDCS | Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Total Score | 16.33 units on a scale | Standard Deviation 3.78 |
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.
Time frame: 1-month follow up (Approximately 11 weeks after baseline assessment)
Population: All available data for participants who completed the 1-month follow-up assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERP Plus tDCS | Client Satisfaction Questionnaire-8: Total Score | 30.75 units on a scale | Standard Deviation 1.26 |
| ERP Plus Sham tDCS | Client Satisfaction Questionnaire-8: Total Score | 28.00 units on a scale | Standard Deviation 5.05 |
Secondary
Rates of Retention in Intervention
Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions.
Time frame: Approximately 6.5 weeks post-baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ERP Plus tDCS | Rates of Retention in Intervention | 3 Participants |
| ERP Plus Sham tDCS | Rates of Retention in Intervention | 4 Participants |
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.
Time frame: 1-month follow up (Approximately 11 weeks after baseline assessment)
Population: All available data for participants who completed the 1-month follow-up assesment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ERP Plus tDCS | Yale-Brown Obsessive-Compulsive Scale: Total Score | 17.25 units on a scale | Standard Deviation 8.18 |
| ERP Plus Sham tDCS | Yale-Brown Obsessive-Compulsive Scale: Total Score | 16.20 units on a scale | Standard Deviation 5.89 |