Intervention for Intrusive Negative Thinking

NCT ID: NCT02394704

Last Updated: 2021-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2021-08-17

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.

Conditions

Intrusive Negative Thinking

Keywords

Rumination; Sensory processing; Non-pharmacological intervention; Depression; Anxiety; PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sensory attention training

Intervention Type: 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.

Non-graded sensory attention training

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

Group Type: ACTIVE_COMPARATOR

Sensory attention training

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liberos LLC

INDUSTRY

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Greg Siegle

Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Greg J Siegle, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Oxford Building

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO13040640

Identifier Type: -

Identifier Source: org_study_id