Obsessive-Compulsive Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALneurofeedback
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.
BEHAVIORALcontrol feedback
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.
Sponsors
National Institute of Mental Health (NIMH)
Yale University
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
* Primary Diagnosis of Current OCD, based on Diagnostic and Statistical Manual (DSM-IV) criteria, a Y-BOCS (Yale-Brown Obsessive-Compulsive Scale) score \>=16 * Principle OCD symptoms- Primary symptoms must be either Cleaning/Contamination or Checking; other symptoms okay * Unmedicated (or medications stable for 8 weeks). * Research group must be able to identify a target region in the orbitofrontal cortex that is related to symptoms
Exclusion criteria
* Active Psychosis; Pervasive Developmental Disorder ; epilepsy or other major neurological disorder * History of major head trauma or psychosurgery * Active Substance Abuse within 6 months * Seizure disorder or other significant neurological disorder * Active Suicidality * Pregnancy * severe claustrophobia, ferromagnetic metal in the body, a pacemaker or defibrillator, or any other condition that would make MRI scanning unsafe or inappropriate * any psychotropic medication other than a selective serotonin reuptake inhibitor (SSRI) antidepressant, anafranil, or a low-dose hypnotic or anxiolytic taken on an as-needed basis * active cognitive/behavioral therapy initiated within the last 3 months (continuation of established maintenance therapy that has been going on for longer than 3 months will not be grounds for exclusion)
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Control over target brain area | Approximately 4 days pre-intervention | 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. |
| Control over the target brain area. | Approximately 4 days post-intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional connectivity patterns in the brain | Approximately 4 days pre-intervention | Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data. |
| Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety. | Approximately 4 days post-intervention | 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. |
| 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 | — |
| Average self-report of washing/checking anxiety to provocative images during a session in which they are instructed to control anxiety | Approximately 4 days pre-intervention | 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. |
Countries
United States
Outcome results
None listed