Intervention for Intrusive Negative Thinking

Sponsor

University of Pittsburgh (Other)

Overall Status

Completed

CT.gov ID

NCT02394704

Collaborator

Liberos LLC (Industry)

194

Enrollment

Location

Arms

69.5

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intrusive Negative Thinking	Other: Sensory attention training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

194 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Graduated Sensory Salience as an Intervention for Intrusive Negative Thinking

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Jun 9, 2021

Actual Study Completion Date :

Aug 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Graded sensory attention training Sensory stimuli will begin at a maximal tolerable intensity and decrease in intensity throughout the training, to shift from involuntary to voluntary attentional focus.	Other: Sensory attention training 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.
Active Comparator: Non-graded sensory attention training Sensory stimuli will begin and be maintained at a minimal detectable intensity to maximize voluntary attentional training.	Other: Sensory attention training 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.

Arm

Intervention/Treatment

Experimental: Graded sensory attention training

Sensory stimuli will begin at a maximal tolerable intensity and decrease in intensity throughout the training, to shift from involuntary to voluntary attentional focus.

Other: Sensory attention training

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.

Active Comparator: Non-graded sensory attention training

Sensory stimuli will begin and be maintained at a minimal detectable intensity to maximize voluntary attentional training.

Other: Sensory attention training

Outcome Measures

Primary Outcome Measures

Sustained attention composite (computer based tasks and physiological measures) [two weeks (five intervention days)]
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.

Secondary Outcome Measures

Depressive severity (patient self-report) [two weeks (five intervention days)]
Clinical variables determined by patient self-report.
Rumination (patient self-report) [two weeks (five intervention days)]
Clinical variables determined by patient self-report.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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