Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT02394704
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02394704
Study Brief:
Protocol Section:
NCT02394704