Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07092826

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Parma, Parma, Emilia-Romagna, Italy

Loading trial locations.

Who can participate

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

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. Yellbrown (Y-BOCS) Score

    Time frame: Baseline (single evaluation session)

    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

Secondary outcomes

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

    Time frame: Baseline (single evaluation session)

    Measurement of childhood trauma exposure using the Childhood Trauma Questionnaire-Short Form (CTQ-SF), a self-report questionnaire with scores ranging from 25 to 125. Higher scores indicate greater levels of reported childhood trauma

  2. Simultaneity Judgement Task (SJ) Performance

    Time frame: Approximately 15 minutes during the pre-training session

    Assessment of audio-tactile simultaneity perception using paired auditory and tactile stimuli presented with varying temporal delays. Participants are asked to judge whether the stimuli occur simultaneously. The task includes multiple trials with systematically varied stimulus onset asynchronies. Performance is defined as the proportion of correct simultaneity judgments, reflecting multisensory temporal integration abilities

  3. Simultaneity Judgement Training (SJT) Performance

    Time frame: Approximately 30-45 minutes during the training session

    Evaluation of training-induced improvements in multisensory temporal integration through a task where participants receive real-time feedback on their simultaneity judgments. A staircase procedure adjusts the delay between stimuli based on participant responses. Performance is measured as improvement in simultaneity judgment accuracy and reduced temporal thresholds from pre- to post-training sessions

Other outcomes

  1. Structural Analysis of Rituals

    Time frame: Baseline (single evaluation session)

    Behavioral analysis of ritual videos conducted with ethnographic software, which breaks down rituals into elementary behavioral units classified into three categories: functional, non-functional, and displaced. The measure quantifies the frequency of each behavioral unit category to assess the complexity and structure of rituals. Frequency counts of behavioral units per category (functional, non-functional, displaced). Baseline and follow-up video recordings.

Sponsors and collaborators

Lead sponsor

Matteo Tonna

Other

Collaborators

  • San Raffaele University Hospital, Italy

Registry information

Official study title

Obsessive-Compulsive Disorder: Formal and Content Modalities, Factors Involved in Loss of Insight, Role of Trauma, and Correlations With Schizophrenia Spectrum Disorders

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Aug 11, 2025

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.

Published trials that share one or more normalized conditions with this study.