NCT05406518

Brief Summary

Applied research carried out in the context of the Community Rehabilitation Service "Dr. Pi i Molist". The objective is to improve the psychosocial intervention carried out with the families of the patients treated (Severe Mental Disorder). It is proposed to carry out a qualitative needs analysis with relatives, patients and professionals, with the intention of detecting possibilities for improvement. With the results obtained, together with the bibliographic recommendations, a new intervention proposal is made and the new results obtained are evaluated. The hypothesis is that a form of intervention more adjusted to the real needs of the population and more effective for the engagement of families and the improvement of the quality of life of patients and their families can be found.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

March 25, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1 month

First QC Date

June 2, 2022

Last Update Submit

June 2, 2022

Conditions

Keywords

familypsychosocialrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Patients' family needs

    Intervention needs in family members of users with severe mental disorders

    6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Arm of intervention

Other: Psychosocial intervention

Interventions

Psychosocial intervention based on the model of family therapy.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Be of legal age (18 years).
  • Have a family member cared for in the SRC with a minimum relationship of 3 months.
  • Have had previous contact with the SRC, having been presented as a family member of reference.
  • Understand, accept and voluntarily sign the informed consent.
  • Properly understand the reasons of the group and the project.
  • Present severe communication or cognitive problems that prevent the understanding of the questions or the possibility of participating in group communication.
  • It is assessed that, due to age or health situation, participation in the group may pose some clinical risk.
  • Be of legal age (18 years).
  • Minimum linkage in the SRC (more than 3 months).
  • Have previously presented a family member to the service as a reference relative.
  • Understand, accept and sign the informed consent.
  • Properly understand the reasons of the group and the project.
  • Present severe communication or cognitive problems that prevent the understanding of the questions or the possibility of participating in group communication.
  • It is assessed that, due to age or health situation, participation in the group may pose some clinical risk.
  • Perform tasks of assistance to users and / or relatives in the SRC.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundació de Gestió Sanitària de l'Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Psychosocial Intervention

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 6, 2022

Study Start

March 25, 2022

Primary Completion

April 26, 2022

Study Completion

June 30, 2023

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations