Intervention for Intrusive Negative Thinking

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.

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

- High scores on rumination; Response Style Questionnaire (RSQ >= 44)

- Automatic Negative Thoughts Questionnaire (ATQ >= 48)

- Dysphoria; Quick Inventory of Depressive Symptomatology (QIDS>= 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 transcutaneous 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

- Underwent electroconvulsive therapy (ECT) < 9 months prior to study entry.

- People who have foreign objects in their body that are not cleared for safety at 3
Tesla 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