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Clinical Trials/NCT03374631
NCT03374631
Completed
N/A

Stimulating the Social Brain

The University of Texas at Dallas1 site in 1 country40 target enrollmentDecember 1, 2017
ConditionsHealthy Adults

Overview

Phase
N/A
Intervention
Not specified
Conditions
Healthy Adults
Sponsor
The University of Texas at Dallas
Enrollment
40
Locations
1
Primary Endpoint
Change in General Paranoid Ideation for Active vs. Sham Simulation
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

This study investigates whether the way in which individuals process social stimuli can be altered, and specifically, whether feelings of paranoia and suspiciousness can be reduced by stimulating the brain's regulatory regions via transcranial Direct Current Stimulation (tDCS).

Detailed Description

Although paranoid ideation is typically associated with severe mental illnesses such as schizophrenia or bipolar disorder, 10-15% of individuals in the general population report experiencing paranoid thoughts on a regular basis. These individuals who are high in sub-clinical paranoia can show impaired work and social functioning as compared to individuals low in sub-clinical paranoia. The wide spread prevalence and negative functional impact of heightened paranoia reinforces the need to develop interventions that may help to reduce problematic patterns of paranoid thinking in both healthy individuals and those with mental illness. Transcranial Direct Current Stimulation (tDCS) is a form of noninvasive neurostimulation which has been proposed as a therapeutic procedure in numerous psychiatric conditions. TDCS therefore may be a promising therapeutic technique for reducing symptoms of psychosis, and specifically paranoia. This study will compare experiences of paranoid ideation in individuals who are high in sub-clinical paranoia across two conditions: active anodal tDCS and sham tDCS.

Registry
clinicaltrials.gov
Start Date
December 1, 2017
End Date
October 1, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amy Pinkham, PhD

Associate Professor

The University of Texas at Dallas

Eligibility Criteria

Inclusion Criteria

  • between the ages of 18 ad 35
  • previous classification as being high in sub-clinical paranoia

Exclusion Criteria

  • diagnosis of mental illness
  • use of psychotropic medication
  • Presence or history of medical, cardiac, or neurological disorders that may affect brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary disease, history of seizures or head trauma with unconsciousness for a period of 15 minutes or greater or CNS tumors)
  • Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with assessment
  • Not proficient in English
  • Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)

Outcomes

Primary Outcomes

Change in General Paranoid Ideation for Active vs. Sham Simulation

Time Frame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation

Level of paranoid ideation will be assessed with the self-report Paranoia Scale (PS; Fenigstein \& Vanable, 1992) both before and after tDCS to assess changes related to tDCS. The PS is a self-report measure designed to assess sub-clinical paranoid thought. Scores range from 20-100 with higher scores indicating higher levels of paranoia. The amount of pre-post change (i.e. PS score assessed before stimulation minus score after stimulation) is the primary value of interest and will be compared between active and sham stimulation. Improvements in paranoia will be indicated by positive values.

Change in Change in Social Paranoia for Active vs. Sham Simulation

Time Frame: Paranoid ideation will be assessed 30 minutes after completion of the active/sham stimulation

Level of paranoid ideation will be assessed with the persecution subscale of the State Social Paranoia Scale (SSPS: Freeman et al., 2007) both before and after tDCS to assess changes related to tDCS. The SSPS is a psychometrically sound 20-item self- report measure assessing current levels of paranoid, positive, and neutral thinking about others. Ten items comprise the persecution subscale, and scores on this subscale range from 10-50 with higher scores indicating greater paranoia. The amount of pre-post change (i.e.SSPS score before stimulation minus SSPS score after stimulation) will be compared between active and sham stimulation. Positive values indicate reductions in paranoia after stimulation.

Secondary Outcomes

  • Trustworthiness Task Score for Active vs. Sham Stimulation(assessed 30 minutes after completion of the active/sham stimulation)
  • Penn Emotion Recognition Test for Active vs. Sham Stimulation(assessed 30 minutes after completion of the active/sham stimulation)

Study Sites (1)

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