Mental DisordersNCT02936141
Psychosocial Intervention Designed to Familial Reintegration of Homeless With Mental Disorder in Maputo and Matola City
A study testing Group psychotherapy in people with Mental Disorders, run by Ministry of Health, Mozambique.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Group psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Aug 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
About this study
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.
Read the detailed description
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.
- Conditions
- Mental Disorders
- Being tested
- Group psychotherapy
- Keywords
- homeless, mental disorders, attendance
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group psychotherapyBehavioural
Also called Cognitive Therapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Group psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every three months after discharge during 12 months
Secondary outcomes (1)
Social skills
Components of social skills were accessed through adaptation of Social Skills Evaluation Scales (EEHS - Tremblay \& Bandeira, 1989) to the mozambican cultural context. The items considered included: verbal skills, conflict resolution and non-verbal skills. This evaluation was made in the beginning of treatment and during the follow-up home visits by trained social workers and psychologists.
Measured: Every three months after discharge during 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startAug 2008
- Primary completionJul 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Mozambique
- Sponsor type
- Other government
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Lídia C. Gouveia, MD, Principal investigator, Mental Health Department of Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936141
- Sponsor's protocol ID
- DSM-000-RS
- Status last verified
- Oct 2016
- First submitted
- 27 Sep 2016
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: There is a need of reformulating database so as to better protect participant's confidentiality
Publications
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.
PubMed 17889244Patra S, Anand K. Homelessness: a hidden public health problem. Indian J Public Health. 2008 Jul-Sep;52(3):164-70.
PubMed 19189843Dennis 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.
PubMed 1772150Scott J. Homelessness and mental illness. Br J Psychiatry. 1993 Mar;162:314-24. doi: 10.1192/bjp.162.3.314.
PubMed 8453425Sullivan 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.
PubMed 11127718Folsom 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.
PubMed 15677603
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial Intervention Targeting Homeless With Mental Disorders in the City of Maputo and Matola: a Study Protocol
- ClinicalTrials.gov ID
- NCT02936141
- Acronym / sponsor ID
- DSM-000-RS
- Conditions
- Mental Disorders
- Keywords
- homeless, mental disorders, attendance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Ministry of Health, MozambiqueOther government
- Collaborators
- Columbia University
- Study start
- Aug 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group psychotherapy | Experimental | Behavioral: Group psychotherapyGroup 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group psychotherapyAlso: Cognitive TherapyIncludes a group (up to 10 participants) weekly session with a duration of 90 minutes where it is stimulated communication, adaptative behaviour and social living | Behavioural | Group psychotherapy |
Primary outcome
Familial reintegration
Time frame: Every three months after discharge during 12 months
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.
1 secondary outcome
Social skills
Time frame: Every three months after discharge during 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Background: PubMed 17889244Patel 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.
- Results publication: PubMed 19189843Patra S, Anand K. Homelessness: a hidden public health problem. Indian J Public Health. 2008 Jul-Sep;52(3):164-70.
- Results publication: PubMed 1772150Dennis 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.
- Results publication: PubMed 8453425Scott J. Homelessness and mental illness. Br J Psychiatry. 1993 Mar;162:314-24. doi: 10.1192/bjp.162.3.314.
- Results publication: PubMed 11127718Sullivan 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.
- Results publication: PubMed 15677603Folsom 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.
- Individual participant dataSharing planned: Yes. There is a need of reformulating database so as to better protect participant's confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lídia C. Gouveia, MD principal investigator
Mental Health Department of Ministry of Health
Questions about this trial
What is this clinical trial studying?
A study testing Group psychotherapy in people with Mental Disorders, run by Ministry of Health, Mozambique.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Familial reintegration (time frame: Every three months after discharge during 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02936141, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.