Neural Correlates of Social Touch and Interoceptive Perception As Potential Biomarker for Impaired Social Functioning

NCT04968223 | Completed

• 1 other identifier: SPIRIT
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies have shown that certain biomarkers of schizophrenia could help to better assess the individual course of the disease and thus, contribute to more personalized treatment options. The aim of the SPIRIT study is to identify potential biomarkers for the prediction of disease-associated outcomes by investigating the neurobiological mechanisms of underlying schizophrenia-related dysfunctions.

Conditions

Schizophrenia

Keywords

Biomarker-based prediction; Precision Psychiatry; Schizophrenia; Social functioning; Social Touch; Interoception; fMRI

Outcome Measures

Primary Outcomes (8)

• Neural responses in a social touch task

  Participants will be measured with functional magnetic resonance imaging (fMRI) while they perceive different types of social and non-social touch

  One-time baseline assessment

• Behavioral responses in a social touch fMRI task

  Measured as behavioral ratings during the social touch fMRI task. During the social touch fMRI task, participants rate the comfort of the tactile stimuli on a visual analogue scale.

  One-time baseline assessment

• Neural responses in an interoception fMRI task

  Participants will be measured with functional magnetic resonance imaging (fMRI) while they perform an interoception task

  One-time baseline assessment

• Behavioral responses in an interoception fMRI task

  Measured by performance on the interoception task. During the interoception fMRI task, participants rate how intensely they perceived their heartbeat or their stomach on a visual analogue scale.

  One-time baseline assessment

• Changes in clinician-rated symptom severity between baseline and follow-ups

  Measured by half-structured interviews (e.g. Positive and Negative Syndrome Scale (PANSS); range: 30-210; higher scores indicating more severe symptoms) for disease-related symptoms

  Baseline, 3 and 6 months follow- up after initial baseline assessment

• Changes in self-reported symptom severity between baseline and follow-ups

  Measured by self-evaluation questionnaires (e.g. Self-assessment of Negative Symptoms (SNS); range 1-20; higher scores indicating more severe symptoms) for disease-related symptoms

  Baseline, 3 and 6 months follow- up after initial baseline assessment

• Changes in clinician-rated social-role functioning between baseline and follow-ups

  Measured by the clinician-rated the social-role functioning scale (range: 1-10; higher scores indicating higher functioning)

  Baseline, 3 and 6 months follow- up after initial baseline assessment

• Changes in self-reported social-role functioning levels between baseline and follow-ups

  Measured by the self-evaluation questionnaires for social-role functioning (e.g. Social Network Index (SNI); range 1-12; higher scores indicating higher functioning)

  Baseline, 3 and 6 months follow-up after initial baseline assessment

Secondary Outcomes (8)

• Bodily maps of social touch

  One-time baseline assessment

• Attitude towards social touch

  One-time baseline assessment

• Interoceptive accuracy

  One-time baseline assessment

• Interoceptive awareness

  One-time baseline assessment

• Blood parameter

  One-time baseline assessment

Study Arms (2)

Patient Group

Patients with Schizophrenia

Control Group

Healthy subjects without family history of psychotic illness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In- and outpatients of the Department of Psychiatry, University of Oldenburg. Patients meeting the criteria for schizophrenia or schizoaffective disorder according to DSM-V will be included in the study. The patients' diagnosis will be verified via the structured clinical interview for DSM-V. Healthy subjects without family history of psychotic illness (control group). Control group will be matched to the patient sample.

You may qualify if:

• Participant is able to provide consent.
• Diagnosis of schizophrenia or schizoaffective disorder according to DSM-V
• Control group: No psychiatric or neurological illness.
• Fluent in German.

You may not qualify if:

• The participant does not fulfill requirements for MRI measurements according to safety guidelines.
• Acute suicidality.
• Current substance dependence.
• A history of head trauma or neurological illness.

Sponsors & Collaborators

• University of Oldenburg: lead
• Danilo Postin, M.Sc.: collaborator

Study Sites (1)

Department of Psychiatry, University of Oldenburg

Bad Zwischenahn, 26160, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples without DNA analysis, Urine samples without DNA analysis

MeSH Terms

Conditions

Schizophrenia; Social Adjustment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Study Officials

• René Hurlemann, Prof.

  Department of Psychiatry, University of Oldenburg

  PRINCIPAL INVESTIGATOR

• Dirk Scheele, Dr.

  Department of Psychiatry, University of Oldenburg

  PRINCIPAL INVESTIGATOR

• Danilo Postin, M.Sc.

  Department of Psychiatry, University of Oldenburg

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Lab Head

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 20, 2021
• Study Start: August 16, 2021
• Primary Completion: May 15, 2024
• Study Completion: November 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Locations

DE (1)