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SchizophreniaNCT03820362

The Role of Personal Identity in Psychotic Symptoms: a Study With the Repertory Grid Technique

An observational study of Schizophrenia and Psychotic Disorders, run by University of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Personal identity is being recently recognized as a core element for mental health disorders, with relevant clinical implications. However, scarcity of data exists on its role in schizophrenia and related disorders. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia, Psychotic Disorders, Self
How many people
85 participants
Where
1 siteSpain
Study dates
Feb 2016to Nov 2018
Phase
Observational
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients recruited from the community, suffering schizophrenia and related disorder

Who may be able to join

  • diagnosis of schizophrenia, psychotic disorder not otherwise specified, delusional disorder, schizoaffective disorder, brief psychotic disorder, or schizophreniform disorder
  • age between 18 and 60 years.
  • patients from outpatient mental health units

Who cannot join

  • traumatic brain injury, dementia, or intellectual disability (pre-morbid IQ <70)
  • current substance dependence

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Parc Sanitary Sant Joan de Déu

    Sant Boi de Llobregat, Barcelona

Other trials in Spain

About this study

Official title: Personal Identity, Cognitive Factors and Psychotic Symptoms in Schizophrenia and Related Disorders: A Cross-sectional Study With the Repertory Grid Technique

Personal identity is being recently recognized as a core element for mental health disorders, with relevant clinical implications. However, scarcity of data exists on its role in schizophrenia and related disorders. The repertory grid (RGT), a technique derived from personal construct theory, has been used in different clinical and non-clinical contexts for the study of the construction perception of self and others, to appreciate aspects of interpersonal construing such as polarization and differentiation (unidimensional thinking) or self-construction.and Our study aims to explore the potential influence of the structure of personal identity and of other relevant cognitive factors (social cognition, metacognition, neurocognition) in positive and negative symptoms in people suffering schizophrenia and related disorders.

Read the detailed description

Over recent years, the importance of the sense of self and personal identity in psychopathology and its treatment has been highlighted. Several studies inspired in the Personal Construct Psychology framework have found a variety of identity characteristics in clinical conditions such as depression or eating disorders, but the evidence in schizophrenia and other psychotic related disorders is scarce.

In addition, current psychological models of positive and negative symptoms highlight the influence of neurocognition, social cognition and self-concepts in the development and maintenance of psychotic experiences. Despite the recognized need of person-centered approaches to understand psychopathology processes in psychosis, psychological models for explaining psychotic symptoms have not explored sufficiently the role of this kind of person-centered measures.

Aim

  1. To examine the influence of the structure of personal identity and other relevant cognitive factors in positive and negative symptoms

Hypotheses

  1. Positive symptoms will be influenced by dichotomous thinking style and construction of self as measured with the RGT.
  2. Negative symptoms will be affected by the richness of the construct system as measured with the RGT.
Keywords
personal identity, personal constructs
Medical subject headings
Schizophrenia, Psychotic Disorders

What is being measured

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

  1. Self-ideal discrepancy, RGT

    Self-esteem. Possible range: 0-0,60. Higher values represent a worse outcome

    Measured: 2 hours

  2. Self-others discrepancy, RGT

    Perceived social isolation. Possible range: 0-0,60. Higher values represent a worse outcome

    Measured: 2 hours

  3. Interpersonal construct differentiation, RGT

    Percentage of Variance Accounted for the First Factor. Possible range: 0-100. Higher values represent a worse outcome

    Measured: 2 hours

  4. Polarization, RGT

    Dichotomous thinking style in the interpersonal context. Possible range: 0-100. Higher values represent a worse outcome

    Measured: 2 hours

  5. Number of elicited constructs, RGT

    Quantity of constructs that the person is able to express to describe self and others. Possible range: 10-50. Higher values represent a better outcome

    Measured: 2 hours

  6. Psychotic symptoms (PANSS, Kay et al. 1987; Peralta & Cuesta, 1994).

    Positive and negative symptoms of psychosis. Range: 7-112. Higher values represent a worse outcome.

    Measured: 40 minutes

  7. Metacognition: BCIS (Beck et al. 2004; Gutiérrez-Zotes et al. 2012); Garety et al, 1991; Dudley et al, 1997)

    Cognitive insight. Range: 0-45. Higher values represent a better outcome

    Measured: 15 minutes

  8. Theory of mind: the Hinting Task (Corcoran et al., 1995; Gil-Sanz et al., 2012)

    Possible range: 0-12. Higher values represent a better outcome

    Measured: 5 minutes

  9. General intellectual functioning (WAIS)

    vocabulary subscale. Range: 70-140. Higher values represent a better outcome

    Measured: 20 minutes

  10. Executive functioning: WSCT (Bergs et al., 1948)

    Wisconsin Card Sorting Test. Categories completed and perseverative errors. Higher values represent a better outcome

    Measured: 15 minutes

Secondary outcomes (7)

  1. Sociodemographical data

    Gender, chronicity, antipsychotic dosage, diagnosis, age, marital status, education level, employment situation

    Measured: 10 minutes

  2. Depressive symptoms

    Beck Depression Inventory (Beck et al. 1996; Sanz, Perdigón \& Vázquez, 2003). Range_ 0-63. High values represent a worse outcome.

    Measured: 10 minutes

  3. General functioning

    Global Assessment of Functioning (Endicot et al., 1976). Range: 0-100. Higher values represent a better outcome.

    Measured: 5 minutes

  4. Self-esteem

    Rosenberg self-esteem scale (Martín Albó et al., 2007). Range: 0-40. Higher values represent a better outcome

    Measured: 5 minutes

  5. Social functioning

    Social Functioning Scale (Birchwood et al., 1990; Torres \& Olivares, 2000). Range: Range: 45-195

    Measured: 20 minutes

  6. Psychological distress

    CORE-OM (Evans et al., 2002; Trujillo et al., 2016). Range: 0-4. Higher values represent a worse outcome

    Measured: 10 minutes

  7. Jumping to Conclusions

    The beads task (Garety et al., 1991; Dudley et al, 1997). Dichotomous: yes/no. A "yes" represents a worse outcome

    Measured: 15 minutes

Timeline

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

  1. First posted29 Jan 2019
  2. Study startFeb 2016
  3. Primary completionNov 2018
  4. Study completionNov 2018

Resources

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
Case only
Time perspective
Cross-sectional
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03820362
Sponsor's protocol ID
FPU15/01721
Status last verified
Jan 2019
First submitted
22 Jan 2019
Last updated
29 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia and Psychotic Disorders, run by University of Barcelona at 1 site in Spain.

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 2 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: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Self-ideal discrepancy, RGT (time frame: 2 hours). The study lists 10 primary outcomes in all. 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 NCT03820362.

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 29 Jan 2019.

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