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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MH104728-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERP plus tDCS | Experimental | ERP plus anodal tDCS of right inferior frontal gyrus |
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| ERP plus sham tDCS | Active Comparator | ERP plus sham tDCS of right inferior frontal gyrus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERP plus tDCS | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Rates of Session Completion | Average number of intervention sessions completed | Approximately 6.5 weeks post-baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Client Satisfaction Questionnaire-8: Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Greenberg, MD, PhD | Butler Hospital | Principal Investigator |
| Sarah Garnaat, PhD | Butler Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02908 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ERP Plus tDCS | Exposure and response prevention (ERP) plus anodal transcranial direct current stimulation (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. |
| FG001 | ERP Plus Sham tDCS | Exposure and response prevention (ERP) plus sham transcranial direct current stimulation (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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Thru Post-treatment Assessment |
| ||||||||||||||||
| 1-month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants with available data at the outcome timepoint | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (approximately 6.5 weeks post-baseline) |
|
Adverse event data were collected from baseline assessment through 1-month follow-up assessment (approximately 11 weeks post-baseline).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Trouble sleeping | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Garnaat | Butler Hospital | 401-455-6659 | sgarnaat@butler.og |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 16, 2018 | Apr 13, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| ERP plus sham tDCS | Other | 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. |
|
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) |
| 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 |
| NOT COMPLETED |
|
| BG001 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Yale-Brown Obsessive-Compulsive Scale (Y-BOCS): Total Score | The Y-BOCS is a well-known measure of obsessive-compulsive disorder (OCD) symptom severity. Total scores can range from 0-40, with higher scores corresponding to greater severity of symptoms. | Mean | Standard Deviation | units on a scale |
|
| 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. |
|
|
|
| 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. | All participants with available data on outcome measure | Posted | Mean | Standard Deviation | units on a scale | Post-treatment (approximately 6.5 weeks post-baseline) |
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| Primary | Rates of Session Completion | Average number of intervention sessions completed | Posted | Mean | Full Range | Sessions | Approximately 6.5 weeks post-baseline |
|
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|
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| 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. | All available data for participants who completed the 1-month follow-up assesment | Posted | Mean | Standard Deviation | units on a scale | 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. | All available data for participants who completed the 1-month follow-up assessment | Posted | Mean | Standard Deviation | units on a scale | 1-month follow up (Approximately 11 weeks after baseline assessment) |
|
|
|
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| Secondary | Rates of Retention in Intervention | Number of randomized participants who remained in the intervention phase of the study and completed all intervention sessions. | Posted | Count of Participants | Participants | Approximately 6.5 weeks post-baseline |
|
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|
| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| EG001 | 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. | 0 | 7 | 0 | 7 | 5 | 7 |
| Nightmares or other sleep disturbance | Nervous system disorders | Systematic Assessment |
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| Feeling drowsy or sleepy | Nervous system disorders | Systematic Assessment |
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| Feeling nervous or hyper | Nervous system disorders | Systematic Assessment |
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| Weakness or Fatigue | Nervous system disorders | Systematic Assessment |
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| Irritable | Nervous system disorders | Systematic Assessment |
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| Poor memory | Nervous system disorders | Systematic Assessment |
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| Trouble concentrating | Nervous system disorders | Systematic Assessment |
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| Feeling strange or unreal | Nervous system disorders | Systematic Assessment |
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| Numbness or tingling | Nervous system disorders | Systematic Assessment |
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| Dizziness or faintness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Blurred vision | Nervous system disorders | Systematic Assessment |
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| Ringing in ears or trouble hearing | Nervous system disorders | Systematic Assessment |
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| Stuffy nose | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dry mouth | Nervous system disorders | Systematic Assessment |
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| Muscle twitching or movements | Nervous system disorders | Systematic Assessment |
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| Trouble sitting still | Nervous system disorders | Systematic Assessment |
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| Tremor or shakiness | Nervous system disorders | Systematic Assessment |
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| Poor coordination or unsteadiness | Nervous system disorders | Systematic Assessment |
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| Heartbeat rapid or pounding | General disorders | Systematic Assessment |
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| Trouble catching breath or hyperventilation | General disorders | Systematic Assessment |
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| Nausea or vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Stomach or abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Loss of sexual interest | Nervous system disorders | Systematic Assessment |
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| Sweating excessively | Nervous system disorders | Systematic Assessment |
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| Fluid retention or swelling | General disorders | Systematic Assessment |
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| Appetite increased | Nervous system disorders | Systematic Assessment |
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| Weight gain | Metabolism and nutrition disorders | Systematic Assessment |
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| Skin rash or allergy | Immune system disorders | Systematic Assessment |
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| Diminished mental acuity/sharpness | Nervous system disorders | Systematic Assessment |
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| Difficulties finding words | Nervous system disorders | Systematic Assessment |
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| Apathy/emotional indifference | Nervous system disorders | Systematic Assessment |
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| Dizziness when you stand up | Vascular disorders | Systematic Assessment |
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| Bruising | Blood and lymphatic system disorders | Systematic Assessment |
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| Hot flashes | Endocrine disorders | Systematic Assessment |
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| Clenching of teeth at night | Nervous system disorders | Systematic Assessment |
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| Unable to sit still | Nervous system disorders | Systematic Assessment |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |