Pittsburgh, Pennsylvania 15213


Purpose:

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.


Study summary:

Intrusive negative cognitions are key transdiagnostic 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.


Criteria:

Inclusion Criteria for all participants: - Signed study consent document - Native English speakers (learned English before age 5) - Right handed - 20/30 vision or better - Free from benzodiazepines and betablockers within 8 hours of evaluations Subject specific Inclusion Criteria - Endorsement of chronic and intrusive negative thinking - Highscores on rumination; Response Style Questionnaire (RSQ >= 44) - Automatic Negative Thoughts Questionnaire (ATQ >= 48) - Dysphoria; Quick Inventory of Depressive Symptomatology (QIDS-SR >= 8) - Must be in current treatment (either Intensive Outpatient Therapy, regular therapy sessions with a licensed provider, or close care by a psychiatrist). This is to ensure the research team is not the patient's only care provider, as this intervention is intended to be adjunct with therapy. Exclusion Criteria: - Refusal or inability to provide informed consent - Current alcohol or substance dependence - Psychotic disorders or psychosis - Neurological disorders (stroke, Alzheimer's, Parkinson's, epilepsy, etc.) - Inability to complete questionnaires in English. The justification is that many of the primary analyses involve assessment of change in self-reported symptoms using measures normed in English. Participants must thus be able to read those measures to give valid indications of the extent to which they have responded to the intervention. - Current use of any psychotropic drugs thought to affect learning, including antipsychotics, anticonvulsants, stimulants, and anti-Parkinsonian drugs. Current is defined as within 2 weeks of testing, 4 weeks for fluoxetine. - Chronic pain that could be exacerbated by TENS unit electrical stimulation - Having any eye problems or difficulties in corrected vision or hearing - Having a North American Adult Reading Test (NAART) equivalent Full Scale Intelligence Quotient < 85 - Being pregnant. Determined by self-report at the interview and by a pregnancy test - Severe or poorly controlled concurrent medical disorders that may cause thinking disruptions or require medication that could cause negative thinking - Current use of medications that could cause affect thinking symptoms. That is, participants need to be able to think clearly to complete the proposed information processing tasks. And they need to be able to learn to be able to make use of the intervention. Medications which compromise clear thinking or which block learning will thus be considered exclusion criteria. - Any implanted electrical device (pacemaker, vagus nerve stimulator implant, etc.) or prior treatment with a vagus nerve stimulator - History of a convulsive disorder - Underwent electroconvulsive therapy (ECT) < 9 months prior to study entry. - Presence of a neurologic disorder or medication therapy known to alter seizure threshold (e.g., brain injury, frequent/severe headaches). - People who have foreign objects in their body that are not cleared for safety at 3T scanning, such as aneurysm clips or pacemakers, will be excluded from the fMRI portion of the study. - Participants deemed "not a good fit" for the study for other reasons (such as, but not limited to, continually arriving late or rescheduling, not being a trustworthy historian or accurate reporter of symptoms, being belligerent with study staff, or presenting an active suicide risk) can also be excluded. - Any heart condition - Any metal implant or subcutaneous metal in the arm


NCT ID:

NCT02394704


Primary Contact:

Principal Investigator
Greg J Siegle, Ph.D.
University of Pittsburgh

Marlee Pyzewski, B.A.
Phone: 412-864-3515
Email: pyzewskiml@upmc.edu


Backup Contact:

Email: caot2@upmc.edu
Tony Cao, B.S.
Phone: 412-864-3517


Location Contact:

Pittsburgh, Pennsylvania 15213
United States

Marlee L Pyzewski, B.A.
Phone: 412-864-3515
Email: pyzewskiml@upmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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