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

NCT ID: NCT07092826

Last Updated: 2025-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2026-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Psychopathological 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

San Raffaele University Hospital, Italy

OTHER

Sponsor Role collaborator

Matteo Tonna

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matteo Tonna

Associate Professor of Psychiatry, University of Parma

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Parma

Parma, Emilia-Romagna, Italy

Site Status

Università degli Studi di Parma - Dipartimento di Medicina e Chirurgia

Parma, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

References

Explore related publications, articles, or registry entries linked to this study.

Insel TR, Akiskal HS. Obsessive-compulsive disorder with psychotic features: a phenomenologic analysis. Am J Psychiatry. 1986 Dec;143(12):1527-33. doi: 10.1176/ajp.143.12.1527.

Reference Type BACKGROUND
PMID: 3789205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27567192 (View on PubMed)

Huber G, Gross G. The concept of basic symptoms in schizophrenic and schizoaffective psychoses. Recenti Prog Med. 1989 Dec;80(12):646-52.

Reference Type BACKGROUND
PMID: 2697899 (View on PubMed)

Henderson JG Jr, Pollard CA. Three types of obsessive compulsive disorder in a community sample. J Clin Psychol. 1988 Sep;44(5):747-52. doi: 10.1002/1097-4679(198809)44:53.0.co;2-2.

Reference Type BACKGROUND
PMID: 3263989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24050777 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21955935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28662637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15124149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2510699 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2684084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1386964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22493586 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19499212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23376865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20483484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7802127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17854908 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11593074 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 938196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16769301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14671731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11704942 (View on PubMed)

Eisen JL, Rasmussen SA. Obsessive compulsive disorder with psychotic features. J Clin Psychiatry. 1993 Oct;54(10):373-9.

Reference Type BACKGROUND
PMID: 8262879 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28434589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23770674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10472711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15711867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17067548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19477004 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31133461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25512596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20015461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11244376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26442944 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19635653 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17918647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8328568 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9055514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28160276 (View on PubMed)

Baer L, Jenike MA. Personality disorders in obsessive compulsive disorder. Psychiatr Clin North Am. 1992 Dec;15(4):803-12.

Reference Type BACKGROUND
PMID: 1461797 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26346234 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18396191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21146190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21287144 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form: Informative Document

View Document

Document Type: Informed Consent Form: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UNIPR-OCD-INSIGHT-290525-V1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Source-monitoring & Psychosis
NCT04236531 UNKNOWN NA