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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH100068 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The aim of this study is to train patients with obsessive-compulsive disorder to control a region of their brain that has been associated with their symptoms. Patients in the experimental group will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control activity in the region during these feedback sessions. A separate group of patients will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce OCD symptoms more than the control feedback.
Original study design recruiting controls who were matched to the experimental group was changed to a randomized design prior to enrollment of the first participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| neurofeedback | Experimental | Two imaging sessions of neurofeedback. |
|
| control feedback | Placebo Comparator | Two imaging sessions of feedback |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neurofeedback | Behavioral | Subject provided with feedback of activity in target brain area in the form of a line graph. Cued to try to make the line go up at certain times and down at other times. |
| Measure | Description | Time Frame |
|---|---|---|
| A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms | Immediately before intervention | |
| A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms | Approximately 4 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Control over target brain area | Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional connectivity patterns in the brain | Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data. | Approximately 4 days pre-intervention |
| Functional connectivity patterns in the brain |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Hampson, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37722238 | Derived | Rance M, Zhao Z, Zaboski B, Kichuk SA, Romaker E, Koller WN, Walsh C, Harris-Starling C, Wasylink S, Adams T Jr, Gruner P, Pittenger C, Hampson M. Neurofeedback for obsessive compulsive disorder: A randomized, double-blind trial. Psychiatry Res. 2023 Oct;328:115458. doi: 10.1016/j.psychres.2023.115458. Epub 2023 Sep 3. |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| control feedback | Behavioral | Subject provided with a control/placebo type of feedback in the form of a line graph. Cued to try to make the line go up at certain times and down at other times. |
|
| Approximately 4 days pre-intervention |
| Control over the target brain area. | Control task scans will be conducted in which subjects are cued to at times to increase activity in their target brain area and at other times to decrease activity in their target brain area. During both conditions they will be presented with symptom provoking images. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area. | Approximately 4 days post-intervention |
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
| Approximately 4 days post-intervention |
| A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms | Approximately 2 weeks post-intervention |
| A modified version of the Yale-Brown Obsessive-Compulsive Symptom scale (Y-BOCS) will be used, that queries subjects regarding symptoms | Approximately 4 weeks post-intervention |
| Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety | Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety. | Approximately 4 days pre-intervention |
| Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety. | Subject instructed to control anxiety, shown provocative pictures and self-reports the anxiety they experience for each image. Responses averaged over session for a single number representing level of anxiety experienced despite efforts to control that anxiety. | Approximately 4 days post-intervention |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |