Obsessive-Compulsive Disorder (OCD)NCT07092826

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

An observational study of Obsessive-Compulsive Disorder (OCD) and Schizophrenia and Schizophrenia Spectrum Psychosis, run by Matteo Tonna at 2 sites in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obsessive-Compulsive Disorder (OCD), Schizophrenia and Schizophrenia Spectrum Psychosis
What is being tested?: Psychopathological assessment and non-invasive multisensory stimulation
How many people: 300 participants
Where: 2 sitesItaly
Study dates: 1 Feb 2023to 1 Feb 2026
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Adult, Older adult

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)

Who may be able to join

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).

Who cannot join

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).

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

University of Parma
Parma, Emilia-Romagna, 43121
Università degli Studi di Parma - Dipartimento di Medicina e Chirurgia
Parma, 43124

Other trials in Italy

About this study

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

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
Being tested: Psychopathological assessment and non-invasive multisensory stimulation
Medical subject headings: Obsessive-Compulsive Disorder, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psychopathological assessment and non-invasive multisensory stimulationOther
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline (single evaluation session)

Secondary outcomes (3)

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
Measured: Baseline (single evaluation session)
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
Measured: Approximately 15 minutes during the pre-training session
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
Measured: Approximately 30-45 minutes during the training session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 20231 Feb 2026

First posted30 Jul 2025
Study start1 Feb 2023
Primary completion1 Feb 2026 (estimated)
Study completion1 Feb 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (44)Papers the sponsor has linked to this study.
Other trials for Obsessive-Compulsive Disorder (OCD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07092826
Sponsor's protocol ID: UNIPR-OCD-INSIGHT-290525-V1
Status last verified: Aug 2025
First submitted: 3 Jun 2025
Last updated: 11 Aug 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 3789205
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
Huber G, Gross G. The concept of basic symptoms in schizophrenic and schizoaffective psychoses. Recenti Prog Med. 1989 Dec;80(12):646-52.
PubMed 2697899
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.
PubMed 3263989
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obsessive-Compulsive Disorder (OCD) trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Obsessive-Compulsive Disorder: Formal and Content Modalities, Factors Involved in Loss of Insight, Role of Trauma, and Correlations With Schizophrenia Spectrum Disorders
ClinicalTrials.gov ID: NCT07092826
Acronym / sponsor ID: UNIPR-OCD-INSIGHT-290525-V1
Conditions: Obsessive-Compulsive Disorder (OCD), Schizophrenia and Schizophrenia Spectrum Psychosis
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: Matteo TonnaUniversity, hospital or other
Collaborators: San Raffaele University Hospital, Italy
Study start: 1 Feb 2023 (actual)
Primary completion: 1 Feb 2026 (estimated)
Study completion: 1 Feb 2026 (estimated)
First posted: 30 Jul 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Cross-sectional

Who may qualify

Ages: 18 to 65 years
Sex: All
Age groups: Adult, Older adult
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)

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (3 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psychopathological assessment and non-invasive multisensory stimulationThis 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.	Other	–

Primary outcome

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

3 secondary outcomes

Childhood Trauma Questionnaire-Short Form (CTQ-SF) Total Score
Time frame: Baseline (single evaluation session)
Simultaneity Judgement Task (SJ) Performance
Time frame: Approximately 15 minutes during the pre-training session
Simultaneity Judgement Training (SJT) Performance
Time frame: Approximately 30-45 minutes during the training session

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
Background: PubMed 3789205Insel 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.
Background: PubMed 27567192Innamorati 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.
Background: PubMed 2697899Huber G, Gross G. The concept of basic symptoms in schizophrenic and schizoaffective psychoses. Recenti Prog Med. 1989 Dec;80(12):646-52.
Background: PubMed 3263989Henderson 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.
Background: PubMed 24050777Hemmings 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.
Background: PubMed 21955935Heins 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.
Background: PubMed 28662637Hagen 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.
Background: PubMed 15124149Gothelf 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.
Background: PubMed 2510699Goodman 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.
Background: PubMed 2684084Goodman 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.
Background: PubMed 1386964Goldman 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.
Background: PubMed 22493586Garcia-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.

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Enrolling by invitation
Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
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Recruiting
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Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
Treatment-refractory Obsessive-compulsive Disorder (trOCD)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Obsessive-Compulsive Disorder (OCD) and Schizophrenia and Schizophrenia Spectrum Psychosis, run by Matteo Tonna at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Yellbrown (Y-BOCS) Score (time frame: Baseline (single evaluation session)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07092826, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.