CClinicalTrials.gg
Active, not recruitingNCT07092826Updated Aug 11, 2025

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

An observational study in Obsessive-Compulsive Disorder (OCD) and Schizophrenia and Schizophrenia Spectrum Psychosis, sponsored by Matteo Tonna. Active, not recruiting at 2 sites in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Matteo Tonna · Observational

From the registry’s dates

  • Primary completion was expected by Feb 2026, 8 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
300
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Obsessive-Compulsive Disorder (OCD)
  • Schizophrenia and Schizophrenia Spectrum Psychosis
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In context

Obsessive-Compulsive Disorder

606 studies on the registry are indexed under Obsessive-Compulsive Disorder; 160 are open to participants now.

This study's planned enrollment of 300 is above the median of 143 across 84 observational studies indexed under Obsessive-Compulsive Disorder.

Browse Obsessive-Compulsive Disorder studies →

Lead sponsor

This is the only study on the registry with Matteo Tonna as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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)

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

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).
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
300 participants (estimated)
Patient registry
No

Interventions

  • OtherPsychopathological assessment and non-invasive multisensory stimulation

    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.

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What researchers measure

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

    Time frame: Baseline (single evaluation session)

Secondary outcomes

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

    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

    Time frame: Baseline (single evaluation session)

  2. Simultaneity Judgement Task (SJ) Performance

    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

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

  3. Simultaneity Judgement Training (SJT) Performance

    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

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

Other outcomes

  1. Structural Analysis of Rituals

    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.

    Time frame: Baseline (single evaluation session)

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Study locations

2 sites
  • University of Parma
    Parma, Emilia-Romagna 43121, Italy
  • Università degli Studi di Parma - Dipartimento di Medicina e Chirurgia
    Parma, 43124, Italy
08

References and documents

Publications

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  • Innamorati M, Erbuto D, Venturini P, Fagioli F, Ricci F, Lester D, Amore M, Girardi P, Pompili M. Factorial validity of the Childhood Trauma Questionnaire in Italian psychiatric patients. Psychiatry Res. 2016 Nov 30;245:297-302. doi: 10.1016/j.psychres.2016.08.044. Epub 2016 Aug 16. PubMed 27567192 ↗
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  • Hemmings SM, Lochner C, van der Merwe L, Cath DC, Seedat S, Stein DJ. BDNF Val66Met modifies the risk of childhood trauma on obsessive-compulsive disorder. J Psychiatr Res. 2013 Dec;47(12):1857-63. doi: 10.1016/j.jpsychires.2013.08.012. Epub 2013 Sep 2. PubMed 24050777 ↗
  • Heins M, Simons C, Lataster T, Pfeifer S, Versmissen D, Lardinois M, Marcelis M, Delespaul P, Krabbendam L, van Os J, Myin-Germeys I. Childhood trauma and psychosis: a case-control and case-sibling comparison across different levels of genetic liability, psychopathology, and type of trauma. Am J Psychiatry. 2011 Dec;168(12):1286-94. doi: 10.1176/appi.ajp.2011.10101531. Epub 2011 Sep 28. PubMed 21955935 ↗
  • Hagen K, Solem S, Opstad HB, Hansen B, Hagen R. The role of metacognition and obsessive-compulsive symptoms in psychosis: an analogue study. BMC Psychiatry. 2017 Jun 29;17(1):233. doi: 10.1186/s12888-017-1392-1. PubMed 28662637 ↗
  • Gothelf D, Aharonovsky O, Horesh N, Carty T, Apter A. Life events and personality factors in children and adolescents with obsessive-compulsive disorder and other anxiety disorders. Compr Psychiatry. 2004 May-Jun;45(3):192-8. doi: 10.1016/j.comppsych.2004.02.010. PubMed 15124149 ↗
  • Goodman WK, Price LH, Rasmussen SA, Mazure C, Delgado P, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. II. Validity. Arch Gen Psychiatry. 1989 Nov;46(11):1012-6. doi: 10.1001/archpsyc.1989.01810110054008. PubMed 2510699 ↗
  • Goodman WK, Price LH, Rasmussen SA, Mazure C, Fleischmann RL, Hill CL, Heninger GR, Charney DS. The Yale-Brown Obsessive Compulsive Scale. I. Development, use, and reliability. Arch Gen Psychiatry. 1989 Nov;46(11):1006-11. doi: 10.1001/archpsyc.1989.01810110048007. PubMed 2684084 ↗
  • Goldman HH, Skodol AE, Lave TR. Revising axis V for DSM-IV: a review of measures of social functioning. Am J Psychiatry. 1992 Sep;149(9):1148-56. doi: 10.1176/ajp.149.9.1148. PubMed 1386964 ↗
  • Garcia-Perez MA, Alcala-Quintana R. Response errors explain the failure of independent-channels models of perception of temporal order. Front Psychol. 2012 Apr 4;3:94. doi: 10.3389/fpsyg.2012.00094. eCollection 2012. PubMed 22493586 ↗
  • Fujisaki W, Nishida S. Audio-tactile superiority over visuo-tactile and audio-visual combinations in the temporal resolution of synchrony perception. Exp Brain Res. 2009 Sep;198(2-3):245-59. doi: 10.1007/s00221-009-1870-x. Epub 2009 Jun 5. PubMed 19499212 ↗
  • Fontenelle JM, Harrison BJ, Santana L, Conceicao do Rosario M, Versiani M, Fontenelle LF. Correlates of insight into different symptom dimensions in obsessive-compulsive disorder. Ann Clin Psychiatry. 2013 Feb;25(1):11-6. PubMed 23376865 ↗
  • Fontenelle IS, Fontenelle LF, Borges MC, Prazeres AM, Range BP, Mendlowicz MV, Versiani M. Quality of life and symptom dimensions of patients with obsessive-compulsive disorder. Psychiatry Res. 2010 Sep 30;179(2):198-203. doi: 10.1016/j.psychres.2009.04.005. Epub 2010 May 18. PubMed 20483484 ↗
  • Foa EB, Kozak MJ, Goodman WK, Hollander E, Jenike MA, Rasmussen SA. DSM-IV field trial: obsessive-compulsive disorder. Am J Psychiatry. 1995 Jan;152(1):90-6. doi: 10.1176/ajp.152.1.90. PubMed 7802127 ↗
  • Ettelt S, Grabe HJ, Ruhrmann S, Buhtz F, Hochrein A, Kraft S, Pukrop R, Klosterkotter J, Falkai P, Maier W, John U, Freyberger HJ, Wagner M. Harm avoidance in subjects with obsessive-compulsive disorder and their families. J Affect Disord. 2008 Apr;107(1-3):265-9. doi: 10.1016/j.jad.2007.08.017. Epub 2007 Sep 12. PubMed 17854908 ↗
  • Erzegovesi S, Cavallini MC, Cavedini P, Diaferia G, Locatelli M, Bellodi L. Clinical predictors of drug response in obsessive-compulsive disorder. J Clin Psychopharmacol. 2001 Oct;21(5):488-92. doi: 10.1097/00004714-200110000-00006. PubMed 11593074 ↗
  • Endicott J, Spitzer RL, Fleiss JL, Cohen J. The global assessment scale. A procedure for measuring overall severity of psychiatric disturbance. Arch Gen Psychiatry. 1976 Jun;33(6):766-71. doi: 10.1001/archpsyc.1976.01770060086012. PubMed 938196 ↗
  • Eisen JL, Mancebo MA, Pinto A, Coles ME, Pagano ME, Stout R, Rasmussen SA. Impact of obsessive-compulsive disorder on quality of life. Compr Psychiatry. 2006 Jul-Aug;47(4):270-5. doi: 10.1016/j.comppsych.2005.11.006. Epub 2006 Apr 19. PubMed 16769301 ↗
  • Eisen JL, Phillips KA, Coles ME, Rasmussen SA. Insight in obsessive compulsive disorder and body dysmorphic disorder. Compr Psychiatry. 2004 Jan-Feb;45(1):10-5. doi: 10.1016/j.comppsych.2003.09.010. PubMed 14671731 ↗
  • Eisen JL, Rasmussen SA, Phillips KA, Price LH, Davidson J, Lydiard RB, Ninan P, Piggott T. Insight and treatment outcome in obsessive-compulsive disorder. Compr Psychiatry. 2001 Nov-Dec;42(6):494-7. doi: 10.1053/comp.2001.27898. PubMed 11704942 ↗
  • Eisen JL, Rasmussen SA. Obsessive compulsive disorder with psychotic features. J Clin Psychiatry. 1993 Oct;54(10):373-9. PubMed 8262879 ↗
  • Eilam D. From an animal model to human patients: An example of a translational study on obsessive compulsive disorder (OCD). Neurosci Biobehav Rev. 2017 May;76(Pt A):67-76. doi: 10.1016/j.neubiorev.2016.12.034. PubMed 28434589 ↗
  • Dettore D, Pozza A, Coradeschi D. Does time-intensive ERP attenuate the negative impact of comorbid personality disorders on the outcome of treatment-resistant OCD? J Behav Ther Exp Psychiatry. 2013 Dec;44(4):411-7. doi: 10.1016/j.jbtep.2013.04.002. Epub 2013 May 15. PubMed 23770674 ↗
  • de Silva P, Marks M. The role of traumatic experiences in the genesis of obsessive-compulsive disorder. Behav Res Ther. 1999 Oct;37(10):941-51. doi: 10.1016/S0005-7967(98)00185-5. PubMed 10472711 ↗
  • De Berardis D, Campanella D, Gambi F, Sepede G, Salini G, Carano A, La Rovere R, Pelusi L, Penna L, Cicconetti A, Cotellessa C, Salerno RM, Ferro FM. Insight and alexithymia in adult outpatients with obsessive-compulsive disorder. Eur Arch Psychiatry Clin Neurosci. 2005 Oct;255(5):350-8. doi: 10.1007/s00406-005-0573-y. Epub 2005 Feb 21. PubMed 15711867 ↗
  • Cromer KR, Schmidt NB, Murphy DL. An investigation of traumatic life events and obsessive-compulsive disorder. Behav Res Ther. 2007 Jul;45(7):1683-91. doi: 10.1016/j.brat.2006.08.018. Epub 2006 Oct 25. PubMed 17067548 ↗
  • Conroy E, Degenhardt L, Mattick RP, Nelson EC. Child maltreatment as a risk factor for opioid dependence: Comparison of family characteristics and type and severity of child maltreatment with a matched control group. Child Abuse Negl. 2009 Jun;33(6):343-52. doi: 10.1016/j.chiabu.2008.09.009. Epub 2009 May 23. PubMed 19477004 ↗
  • Cheng YF, Chen VC, Yang YH, Chen KJ, Lee YC, Lu ML. Risk of schizophrenia among people with obsessive-compulsive disorder: A nationwide population-based cohort study. Schizophr Res. 2019 Jul;209:58-63. doi: 10.1016/j.schres.2019.05.024. Epub 2019 May 24. PubMed 31133461 ↗
  • Cederlof M, Lichtenstein P, Larsson H, Boman M, Ruck C, Landen M, Mataix-Cols D. Obsessive-Compulsive Disorder, Psychosis, and Bipolarity: A Longitudinal Cohort and Multigenerational Family Study. Schizophr Bull. 2015 Sep;41(5):1076-83. doi: 10.1093/schbul/sbu169. Epub 2014 Dec 15. PubMed 25512596 ↗
  • Catapano F, Perris F, Fabrazzo M, Cioffi V, Giacco D, De Santis V, Maj M. Obsessive-compulsive disorder with poor insight: a three-year prospective study. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Mar 17;34(2):323-30. doi: 10.1016/j.pnpbp.2009.12.007. Epub 2009 Dec 16. PubMed 20015461 ↗
  • Catapano F, Sperandeo R, Perris F, Lanzaro M, Maj M. Insight and resistance in patients with obsessive-compulsive disorder. Psychopathology. 2001 Mar-Apr;34(2):62-8. doi: 10.1159/000049282. PubMed 11244376 ↗
  • Bulli F, Melli G, Cavalletti V, Stopani E, Carraresi C. Comorbid Personality Disorders in Obsessive-Compulsive Disorder and Its Symptom Dimensions. Psychiatr Q. 2016 Jun;87(2):365-76. doi: 10.1007/s11126-015-9393-z. PubMed 26442944 ↗
  • Briggs ES, Price IR. The relationship between adverse childhood experience and obsessive-compulsive symptoms and beliefs: the role of anxiety, depression, and experiential avoidance. J Anxiety Disord. 2009 Dec;23(8):1037-46. doi: 10.1016/j.janxdis.2009.07.004. Epub 2009 Jul 8. PubMed 19635653 ↗
  • Boyer P, Lienard P. Why ritualized behavior? Precaution Systems and action parsing in developmental, pathological and cultural rituals. Behav Brain Sci. 2006 Dec;29(6):595-613; discussion 613-50. doi: 10.1017/s0140525x06009332. PubMed 17918647 ↗
  • Black DW, Noyes R Jr, Pfohl B, Goldstein RB, Blum N. Personality disorder in obsessive-compulsive volunteers, well comparison subjects, and their first-degree relatives. Am J Psychiatry. 1993 Aug;150(8):1226-32. doi: 10.1176/ajp.150.8.1226. PubMed 8328568 ↗
  • Bernstein DP, Ahluvalia T, Pogge D, Handelsman L. Validity of the Childhood Trauma Questionnaire in an adolescent psychiatric population. J Am Acad Child Adolesc Psychiatry. 1997 Mar;36(3):340-8. doi: 10.1097/00004583-199703000-00012. PubMed 9055514 ↗
  • Bey K, Lennertz L, Riesel A, Klawohn J, Kaufmann C, Heinzel S, Grutzmann R, Kathmann N, Wagner M. Harm avoidance and childhood adversities in patients with obsessive-compulsive disorder and their unaffected first-degree relatives. Acta Psychiatr Scand. 2017 Apr;135(4):328-338. doi: 10.1111/acps.12707. Epub 2017 Feb 3. PubMed 28160276 ↗
  • Baer L, Jenike MA. Personality disorders in obsessive compulsive disorder. Psychiatr Clin North Am. 1992 Dec;15(4):803-12. PubMed 1461797 ↗
  • Alonso P, Lopez-Sola C, Real E, Segalas C, Menchon JM. Animal models of obsessive-compulsive disorder: utility and limitations. Neuropsychiatr Dis Treat. 2015 Aug 4;11:1939-55. doi: 10.2147/NDT.S62785. eCollection 2015. PubMed 26346234 ↗
  • Alonso P, Menchon JM, Segalas C, Jaurrieta N, Jimenez-Murcia S, Cardoner N, Labad J, Real E, Pertusa A, Vallejo J. Clinical implications of insight assessment in obsessive-compulsive disorder. Compr Psychiatry. 2008 May-Jun;49(3):305-12. doi: 10.1016/j.comppsych.2007.09.005. Epub 2007 Dec 21. PubMed 18396191 ↗
  • Afifi TO, Mather A, Boman J, Fleisher W, Enns MW, Macmillan H, Sareen J. Childhood adversity and personality disorders: results from a nationally representative population-based study. J Psychiatr Res. 2011 Jun;45(6):814-22. doi: 10.1016/j.jpsychires.2010.11.008. Epub 2010 Dec 10. PubMed 21146190 ↗
  • Adam Y, Meinlschmidt G, Gloster AT, Lieb R. Obsessive-compulsive disorder in the community: 12-month prevalence, comorbidity and impairment. Soc Psychiatry Psychiatr Epidemiol. 2012 Mar;47(3):339-49. doi: 10.1007/s00127-010-0337-5. Epub 2011 Feb 2. PubMed 21287144 ↗

Study documents

  • Study protocol · May 17, 2025
  • Informed consent form · May 17, 2025
  • Informed consent form · Jan 28, 2023

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07092826
Lead sponsor
Matteo Tonna
Collaborators
San Raffaele University Hospital, Italy
Responsible party
Matteo Tonna (Associate Professor of Psychiatry, University of Parma, Azienda Ospedaliero-Universitaria di Parma) — Sponsor-investigator
First posted
Jul 30, 2025
Start date
Feb 1, 2023
Primary completion
Feb 1, 2026 (estimated)
Completion
Feb 1, 2026 (estimated)
Last update
Aug 11, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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