Clinical trial NCT02394704: Intervention for Intrusive Negative Thinking
Official title: Graduated Sensory Salience as an Intervention for Intrusive Negative Thinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrusive Negative Thinking
Keywords: Rumination
Sensory processing
Non-pharmacological intervention
Depression
Anxiety
PTSD
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Liberos LLC
First posted: 2015-03-20
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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
* 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

Primary outcomes:
measure: Sustained attention composite (computer based tasks and physiological measures)
timeFrame: two weeks (five intervention days)
Secondary outcomes:
measure: Depressive severity (patient self-report)
timeFrame: two weeks (five intervention days)
measure: Rumination (patient self-report)
timeFrame: two weeks (five intervention days)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Oxford Building
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Greg J Siegle, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: