NCT04304417

Brief Summary

This study analyzes which variables enhance or hinder community integration among people with severe mental disorder. Participants will complete a questionnaire to test our hypotheses:

  • Hypothesis 1: group identification predicts less self-dehumanization and self-stigma, and more empowerment, these in turn predict more community integration.
  • Hypothesis 2: the relationship between group identification and self-dehumanization and self-stigma is moderated by group value.
  • Hypothesis 3: when group identification is low, group identification predicts higher community integration, but this relationship is mediated by diagnosis concealment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2020

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 27, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

March 6, 2020

Last Update Submit

May 23, 2022

Conditions

Keywords

Severe Mental DisorderCommunity IntegrationGroup IdentityStigmaDehumanization

Outcome Measures

Primary Outcomes (3)

  • Physical integration

    Self-reported frequency of activities realized outdoors, measured with the subscale 'Leisure and community' from the 'Independent living skills survey'. Each item is scored from 1 (never) to 5 (always).

    1 day. Measured the day of the study.

  • Social integration

    Self-reported frequency of support available, measured with the Medical Outcome Study Social Support Survey (MOS-SSS). Each item is scored from 1 (never) to 5 (always).

    1 day. Measured the day of the study.

  • Psychological integration

    Self-reported feeling of belonging to the general community and to the community of people with mental disorder. It is measured with the subscale 'Belonging' from the 'Community Integration Measure'. Each item is scored from 1 (I totally disagree) to 5 (I totally agree).

    1 day. Measured the day of the study.

Secondary Outcomes (5)

  • Self-dehumanization

    1 day. Measured the day of the study.

  • Self-stigma

    1 day. Measured the day of the study.

  • Empowerment

    1 day. Measured the day of the study.

  • Group identity

    1 day. Measured the day of the study.

  • Group value

    1 day. Measured the day of the study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population of the study are adult people with a diagnosis of severe mental disorder (SMD), who are users of the public centers of social care for people with SMD of the State of Madrid in Spain.

You may qualify if:

  • Having a diagnosis of severe mental disorder.
  • Having disorder consciousness.

You may not qualify if:

  • Being underage.
  • Being legally incapacitated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grupo 5

Madrid, State of Madrid, Spain

Location

MeSH Terms

Conditions

Bipolar DisorderPersonality DisordersPsychotic DisordersMental DisordersSocial StigmaDehumanization

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersSchizophrenia Spectrum and Other Psychotic DisordersSocial BehaviorBehavior

Study Officials

  • Carolina Ugidos

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 11, 2020

Study Start

February 17, 2020

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

May 27, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations