Obsessive-Compulsive Disorder: Insight, Trauma, and Links to Schizophrenia Spectrum Disorders

NCT07092826 | Active Not Recruiting

• 1 other identifier: UNIPR-OCD-INSIGHT-290525-V1
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to better understand Obsessive-Compulsive Disorder (OCD) by examining the types and patterns of OCD symptom presentation. The investigators seek to determine how these symptoms impact overall daily functioning. The study will also explore factors contributing to loss of insight in individuals with OCD, focusing on the potential roles of trauma, personality traits, and disorder severity. This may assist in identifying subgroups of patients who respond more favorably to treatment. Additionally, the study will investigate how individuals with OCD and schizophrenia spectrum symptoms respond to combined sensory stimuli (e.g., auditory and tactile). The goal is to determine whether these responses are associated with specific brain processing patterns, trauma history, or characteristics of compulsive behavior. Insights from this research may help clarify why certain individuals develop repetitive behaviors such as checking and rituals. Participants will be adults aged 18 to 65 diagnosed with OCD or schizophrenia spectrum disorders. Recruitment will occur through psychiatric clinics in Parma. Participation requires signed informed consent.

Conditions

Obsessive-Compulsive Disorder (OCD); Schizophrenia and Schizophrenia Spectrum Psychosis

Outcome Measures

Primary Outcomes (1)

• Yellbrown (Y-BOCS) Score

  Assessment of obsessive-compulsive symptom severity using the Yellow-Brown Obsessive-Compulsive Scale (Y-BOCS). The total score ranges from 0 to 40, with higher scores indicating more severe symptoms. This scale is a clinician-administered questionnaire evaluating obsessions and compulsions

  Baseline (single evaluation session)

Secondary Outcomes (3)

• Childhood Trauma Questionnaire-Short Form (CTQ-SF) Total Score

  Baseline (single evaluation session)

• Simultaneity Judgement Task (SJ) Performance

  Approximately 15 minutes during the pre-training session

• Simultaneity Judgement Training (SJT) Performance

  Approximately 30-45 minutes during the training session

Other Outcomes (1)

• Structural Analysis of Rituals

  Baseline (single evaluation session)

Interventions

Psychopathological assessment and non-invasive multisensory stimulation OTHER

This intervention consists of a non-invasive, cross-sectional assessment involving standardized psychopathological interviews and multisensory stimulation tasks (auditory, tactile, and combined). It is designed to explore formal and content-related features of obsessive-compulsive symptoms, insight levels, and trauma-related correlates in patients with OCD and schizophrenia spectrum disorders. No pharmacological treatment or experimental therapy is administered as part of this study.

Eligibility Criteria

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

Study Population

The patients are affiliated with the facilities of the Integrated Department of Mental Health and Pathological Addictions (DAI-SMDP) of the Parma Local Health Authority (AUSL Parma)

You may qualify if:

• Diagnosis of Obsessive-Compulsive Disorder (OCD) and/or Schizophrenia Spectrum Disorder according to DSM-5 criteria (APA, 2013), as determined by a structured clinical interview (SCID-5-CV) (First et al., 2016).
• Age between 18 and 65 years.
• Participant agreement to take part in the study (informed consent).

You may not qualify if:

• General medical condition that may be related to the psychiatric disorder.
• Alcohol or substance dependence or abuse.
• Cognitive impairment (score below 25 on the Mini Mental State Examination).

Sponsors & Collaborators

• Matteo Tonna: lead
• San Raffaele University Hospital, Italy: collaborator

Study Sites (2)

University of Parma

Parma, Emilia-Romagna, 43121, Italy

Location

Università degli Studi di Parma - Dipartimento di Medicina e Chirurgia

Parma, 43124, Italy

Location

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MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Schizophrenia

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Psychiatry, University of Parma

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: July 30, 2025
• Study Start: February 1, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

IT (2)