NCT03820362

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

2.8 years

First QC Date

January 22, 2019

Last Update Submit

January 25, 2019

Conditions

SchizophreniaPsychotic DisordersSelf

Keywords

personal identitypersonal constructs

Outcome Measures

Primary Outcomes (10)

  • Self-ideal discrepancy, RGT

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

    2 hours

  • Self-others discrepancy, RGT

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

    2 hours

  • Interpersonal construct differentiation, RGT

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

    2 hours

  • Polarization, RGT

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

    2 hours

  • 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

    2 hours

  • 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.

    40 minutes

  • 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

    15 minutes

  • 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

    5 minutes

  • General intellectual functioning (WAIS)

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

    20 minutes

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

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

    15 minutes

Secondary Outcomes (7)

  • Sociodemographical data

    10 minutes

  • Depressive symptoms

    10 minutes

  • General functioning

    5 minutes

  • Self-esteem

    5 minutes

  • Social functioning

    20 minutes

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients recruited from the community, suffering schizophrenia and related disorder

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parc Sanitary Sant Joan de Déu

Sant Boi de Llobregat, Barcelona, Spain

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Helena García-Mieres, MsC

    Universitat de Barcelona & Parc Sanitari Sant Joan de Déu

    PRINCIPAL INVESTIGATOR

  • Susana Ochoa, PhD

    Parc Sanitari Sant Joan de Déu

    STUDY DIRECTOR

  • Guillem Feixas, PhD

    University of Barcelona

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc., Ph.D. Cand.

Study Record Dates

First Submitted

January 22, 2019

First Posted

January 29, 2019

Study Start

February 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

ES(1)