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| Name | Class |
|---|---|
| Liberos LLC | INDUSTRY |
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Intrusive negative thinking styles such as rumination are typical of many psychiatric disorders, are difficult to treat, and predict poor treatment outcome. The investigators propose to evaluate a new intervention for negative thinking that capitalizes and builds on the preserved ability to attend to physical sensation. The investigators will examine changes in physiological mechanisms and symptoms.
Intrusive negative cognitions are key features of many psychiatric disorders, are difficult to treat, and predict poor outcomes in conventional and neurobehavioral interventions. Here, we evaluate the extent to which a novel intervention capitalizing on a preserved neurocircuitry for attending to evolutionarily salient somatosensory stimuli can be used to train attentional mechanisms to override otherwise pre-potent negative cognitions. The initial period will involve open-label intervention refinement and mechanistic evaluation of mechanism; N=35 individuals with high levels of intrusive negative cognitions and dysphoria will be assessed pre/post intervention in the graded sensory training condition. Success will suggest a new intervention pathway for a traditionally treatment-resistant dimension of psychopathology. The second phase will be a randomized trial of 70 participants equally allocated to graded and non-graded training conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Graded sensory attention training | Experimental | Sensory stimuli will begin at a maximal tolerable intensity and decrease in intensity throughout the training, to shift from involuntary to voluntary attentional focus. |
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| Non-graded sensory attention training | Active Comparator | Sensory stimuli will begin and be maintained at a minimal detectable intensity to maximize voluntary attentional training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sensory attention training | Other | Participants will be instructed to attend to sensory stimuli and to press a button as quickly and accurately as possible while ruminating. Stimuli will consist of vibration via a wearable subwoofer or non-painful electrical muscle stimulation (10Hz biphasic current with a pulse width of 200us with rectangular 2" electrodes placed on the back near the shoulders) or vibratory stimulation with a vibroacoustic element placed on the back near the shoulders. Up to four sessions will be approximately 45 minutes, over the course of two weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained attention composite (computer based tasks and physiological measures) | Sustained attention is operationalized by performance on computer-based tasks (sensitivity, reaction times) and associated physiological measures (pupil dilation, eye movements, heart rate, EEG) and central measures (fMRI derived reactivity in affect, somatosensory, and attention networks). These metrics will be interpreted together as a meta-analytic composite by counting the number of component measures with significant change in association with the intervention in comparison to a permutation-test derived critical number of indices change under the null hypothesis given the autocorrelation of the administered measures. | two weeks (five intervention days) |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive severity (patient self-report) | Clinical variables determined by patient self-report. | two weeks (five intervention days) |
| Rumination (patient self-report) | Clinical variables determined by patient self-report. |
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Inclusion Criteria for all participants:
Subject specific Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg J Siegle, Ph.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Building | Pittsburgh | Pennsylvania | 15213 | United States |
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| ID | Term |
|---|---|
| D000079562 | Rumination Syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| two weeks (five intervention days) |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |