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Completed

NCT Number: NCT03374631

Stimulating the Social Brain

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).

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Key information

Conditions

Healthy Adults

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Unversity of Texas at Dallas

Richardson, Texas, 75080, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Active anodal tDCS

Device

active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation

Sham tDCS

Device

sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation

Primary outcomes

  1. 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.

  2. 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

  1. Trustworthiness Task Score for Active vs. Sham Stimulation

    Time frame: assessed 30 minutes after completion of the active/sham stimulation

    Participants will complete the Trustworthiness Task (Adolphs, Tranel, & Damasio, 1998), which asks individuals to view 42 images of others and rate their level of trustworthiness on a scale from -3 to 3. Scores range from -126 to 126. Higher scores indicate greater perceptions of trustworthiness. Mean ratings following each stimulation type (active vs. sham) are calculated.

  2. Penn Emotion Recognition Test for Active vs. Sham Stimulation

    Time frame: assessed 30 minutes after completion of the active/sham stimulation

    The Emotion Recognition 40 (ER-40; Kohler, Turner, Bilker, Brinsinger, Siegel, Kanes... Gur, 2003) is a standardized, computer administered measure of facial affect recognition ability. It includes 40 color photographs of faces expressing 4 basic emotions (i.e. happiness, sadness, anger or fear) and neutral expressions. Participants view one face at a time and are asked to choose the correct emotion for each face. Scores range from 0-40 with higher scores indicating better accuracy. Mean performance following each stimulation type (active vs. sham) are calculated.

Sponsors and collaborators

Lead sponsor

The University of Texas at Dallas

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 15, 2017
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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