NCT02936141

Brief Summary

The aim of this project is to describe the mental health status of the homeless people in Maputo and Matola utilising standardised clinical and socio-demographic assessments. Simultaneously; the study aims to determine the influence of a psychosocial intervention in patients with apparent signs of mental illness, aiming at his/her family reintegration; This study is conducted hypothesizing that the familial reintegration after intervention would be the same across patients with different mental disorders.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

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

August 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

September 27, 2016

Last Update Submit

October 14, 2016

Conditions

Keywords

homeless, mental disorders, attendance

Outcome Measures

Primary Outcomes (1)

  • Familial reintegration

    The return of the participant to family of origin after completing the intervention at the hospital level. This outcome was based on the questionnaire: "inquiry homeless data collection", drawn for the study. It contains a dichotomized question: patient living with the relatives during the first visit (yes or no), second visit (yes or no) and third visit (yes or no) throughout follow-up visits. When the answer was yes in three consecutive visits, he/she was considered reintegrated in the family in the present study.

    Every three months after discharge during 12 months

Secondary Outcomes (1)

  • Social skills

    Every three months after discharge during 12 months

Study Arms (1)

Group psychotherapy

EXPERIMENTAL

Group psychotherapy sessions includes the following: training of social skills (such as communication, social interaction and assertive behaviors), cognitive stimulation and training of activities of daily living (such as personal hygiene, hygiene of spaces and standardized mealtimes)

Behavioral: Group psychotherapy

Interventions

Includes a group (up to 10 participants) weekly session with a duration of 90 minutes where it is stimulated communication, adaptative behaviour and social living

Also known as: Cognitive Therapy
Group psychotherapy

Eligibility Criteria

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

You may qualify if:

  • \- People with apparent signs of mental disorder, who had been living on the street for more than 30 days who agreed to sign or give a verbal consent (by herself/himself, family/relatives)

You may not qualify if:

  • Homeless persons without apparent signs of mental illness, with obvious physical illness, seemingly under the age of 18 and that were not able to give informed consent/those who it was not possible to contact their relatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Patel V, Simbine AP, Soares IC, Weiss HA, Wheeler E. Prevalence of severe mental and neurological disorders in Mozambique: a population-based survey. Lancet. 2007 Sep 22;370(9592):1055-60. doi: 10.1016/S0140-6736(07)61479-2.

    PMID: 17889244BACKGROUND
  • Patra S, Anand K. Homelessness: a hidden public health problem. Indian J Public Health. 2008 Jul-Sep;52(3):164-70.

  • Dennis DL, Buckner JC, Lipton FR, Levine IS. A decade of research and services for homeless mentally ill persons. Where do we stand? Am Psychol. 1991 Nov;46(11):1129-38. doi: 10.1037//0003-066x.46.11.1129.

  • Scott J. Homelessness and mental illness. Br J Psychiatry. 1993 Mar;162:314-24. doi: 10.1192/bjp.162.3.314.

  • Sullivan G, Burnam A, Koegel P. Pathways to homelessness among the mentally ill. Soc Psychiatry Psychiatr Epidemiol. 2000 Oct;35(10):444-50. doi: 10.1007/s001270050262.

  • Folsom DP, Hawthorne W, Lindamer L, Gilmer T, Bailey A, Golshan S, Garcia P, Unutzer J, Hough R, Jeste DV. Prevalence and risk factors for homelessness and utilization of mental health services among 10,340 patients with serious mental illness in a large public mental health system. Am J Psychiatry. 2005 Feb;162(2):370-6. doi: 10.1176/appi.ajp.162.2.370.

MeSH Terms

Conditions

Mental Disorders

Interventions

Psychotherapy, GroupCognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and ActivitiesBehavior Therapy

Study Officials

  • Lídia C. Gouveia, MD

    Mental Health Department of Ministry of Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 27, 2016

First Posted

October 18, 2016

Study Start

August 1, 2008

Primary Completion

July 1, 2009

Study Completion

December 1, 2010

Last Updated

October 18, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

There is a need of reformulating database so as to better protect participant's confidentiality