Mental Disorders Clinical Trial
Official title:
Psychosocial Intervention Targeting Homeless With Mental Disorders in the City of Maputo and Matola: a Study Protocol
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.
Even though the Mental Health Program in Mozambique have been providing and implementing
services to reduce the gap in the treatment of mental disorders, there are no specific
programs for homeless people. Additionally, in the country, there are no specific
interventions for the homeless mentally ill, combining hospital and community interventions.
Therefore we designed a pilot study to evaluate the profile of those individuals who live on
the streets with apparent mental illness, and the effectiveness of the intervention plan
considered for this purpose. Utilising an intervention study in community and hospital
settings, we aim to understand the mental health status of the homeless people and appraise
the effectiveness and acceptability of a multidisciplinary intervention in a low-income
country. Our main hypothesis is that the intervention designed to facilitate and maintain
the homeless people with mental health disorders in treatment through the implementation of
evidence-based intervention can increase the reintegration of homeless people in their
community, and that the familial reintegration would be the same among patients with
different mental disorders. The present study was waived of approval by the National
Bioethics Committee for Health, since it was realized on behalf of an activity held by the
Ministry of Health. The study will be conducted in Maputo and Matola cities both in the
southern region of Mozambique. These cities were chosen because of their accessibility and
due to the dimension of the homeless population, representing an urban and suburban area
respectively. The selection of the sample of homeless will be by convenience. After a period
of mapping (to study homeless` routines including usual pathways), potential participants
and their relatives will be approached. Members of the community such as the head of the
block and member of the neighborhood will be involved to facilitate the family contact that
after explanation about the goals of the program will be asked to give their consent; later
the potential participant will be approached on the street and informed about the objectives
of the program, the length of the study, any benefits or risk they might incur as
participants, who to contact in case they have questions or concerns and their right to
decline to participate without coercion. Then, they will be proposed referral to inpatient
unit where it will be done the psychological and medical treatment, rehabilitation and
family reintegration and will be asked to give their informed consent as well. Upon arrival
to the psychiatric hospital, a multidisciplinary assistance team will welcome the homeless
by initiating the intervention with the personal hygiene, including shave and haircut. The
diagnosis will be established by experienced psychiatrists, using a structured diagnostic
assessment instrument - Mini International Neuropsychiatric Interview (MINI) - and a
socio-demographic inventory (with data such as age, name, gender, marital status,
occupation, education, employment, religion and economic conditions). After psychiatric
evaluation, participants will initiate psychopharmacological treatment according to the
needs of each patient. Laboratorial analyses will be performed to exclude organic diseases,
and in positive cases an additional clinical examination will be requested. Once the
symptoms are controlled, the patients will be submitted to a psychological evaluation and
initiate group psychotherapy interventions. Group psychotherapy sessions included 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). In a subsequent phase,
for the family reintegration preparation process, group psychotherapy sessions and
psychoeducation will be held involving patients' relatives.
Furthermore social workers in coordination with the community leaders and the municipal
authorities will ask for permission to do home visits to the relatives of the participants
so as to create the appropriated environment to the family reintegration process. Throughout
these visits, the level of family involvement regarding the therapeutic process, the
patient's health status, and the search information of their family member's disease will be
assessed. Family reintegration refers to the process of return from an institution or
shelter to the original, extensive or adopted family. In our study, we consider family
reintegration as the return of the participant to family of origin after completing the
intervention at the hospital level.
After the family reintegration it will be made a follow up every 3 months during 12 months.
Participants will be registered and followed in clinic in nearby sanitary units of their
residence areas as usual procedure after discharge of patients of the psychiatric unity.
Data analysis will be performed using the Statistical Package for Social Sciences version
22, for the quantitative data analysis. All the collected information will be coded
including the identification of patients, relatives, health professionals and community
leaders involved in the study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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