xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007105</url>
    </required_header>
    <id_info>
      <org_study_id>28346</org_study_id>
      <secondary_id>EPPHZT74</secondary_id>
      <nct_id>NCT06007105</nct_id>
    </id_info>
    <brief_title>SUCCEED Africa: Support, Comprehensive Care and Empowerment of People With Psychosocial Disabilities</brief_title>
    <acronym>SUCCEED</acronym>
    <official_title>SUCCEED Africa: Protocol for a Multi-method Pilot Study of a Community-based Intervention for People With Psychosis in West and Southeast Africa</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>London School of Hygiene and Tropical Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Ibadan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Malawi</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Makeni</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Zimbabwe</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Zimbabwe National Association for Mental Health (ZIMNAMH)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mental Health Users and Carers Association (MeHUCA) Malawi</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Asido Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Mental Health Coalition Sierra Leone</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>London School of Hygiene and Tropical Medicine</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Although psychotic disorders typically affect less than 1% of the population, they are a&#xD;
        significant cause of disability worldwide. Psychotic symptoms such as hallucinations,&#xD;
        delusions and suicidal ideation can be profoundly disturbing, and negatively impact daily&#xD;
        living. However, the social consequences of psychosis are often even more troubling than the&#xD;
        symptoms. For example, people with psychosis have a high risk of experiencing violence,&#xD;
        poverty, homelessness, incarceration, and unemployment, among other adverse outcomes.&#xD;
  &#xD;
        There is a need for a range of accessible, appropriate interventions for people with&#xD;
        psychosis to be delivered to those in the most vulnerable situations, including in&#xD;
        low-resource settings in sub-Saharan Africa. A systematic review recently carried out as part&#xD;
        of the formative research for SUCCEED identified 10 studies evaluating the impact of&#xD;
        interventions for people with psychosis in Africa, most of which had a strongly clinical&#xD;
        focus. The review concluded that there was a need for further research involving people with&#xD;
        lived experience of psychosis in designing and evaluating holistic interventions that meet&#xD;
        their diverse needs, within and beyond the health sector.&#xD;
  &#xD;
        SUCCEED Africa is a six-year Health Research Programme Consortium (RPC) that has brought&#xD;
        together people with lived experience of psychosis and people with professional experience&#xD;
        (researchers, clinicians) from four African countries (Malawi, Nigeria, Sierra Leone,&#xD;
        Zimbabwe) to co-produce a community-based intervention for psychosis, using a Theory of&#xD;
        Change-driven approach. The SUCCEED intervention takes the World Health Organisation's&#xD;
        (WHO's) CBR Matrix as a point of departure to consider the multifaceted needs of people&#xD;
        living with psychosis and other psychosocial disabilities, and how best to meet these needs&#xD;
        by mobilising the resources of individuals and families affected, as well as their broader&#xD;
        communities.&#xD;
  &#xD;
        This protocol describes a pilot study in which the SUCCEED intervention will be delivered and&#xD;
        evaluated on a small scale, in preparation for a larger multi-country research evaluation&#xD;
        using more rigorous methods, including randomised controlled trials in Nigeria and Zimbabwe&#xD;
        and observational studies in Malawi and Sierra Leone, respectively. The main outcome of&#xD;
        interest is change in subjective quality of life among participants with lived experience of&#xD;
        psychosis who are offered the intervention over a four-month follow up period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Recognising the need for a framework for interventions to support people with psychosocial&#xD;
        disabilities in LMICs, the WHO's 2010 CBR Guidelines included a special supplement on mental&#xD;
        health, which drew mainly from expert opinion, evidence in community mental health, and basic&#xD;
        development principles, to make recommendations for best practice. However, a 2016 review&#xD;
        examining CBR for disabilities in LMICs identified only one example of CBR for psychosocial&#xD;
        disabilities in Sub-Saharan Africa. The authors concluded that there was a need for more&#xD;
        evidence from this region, in particular.&#xD;
  &#xD;
        As part of SUCCEED Africa's formative research, a systematic review of the grey literature on&#xD;
        CBR for psychosocial disabilities in LMICs was undertaken, in case there was in fact evidence&#xD;
        available that had been excluded as a result of the previous review's strict eligibility&#xD;
        criteria. The grey literature review identified 33 different CBR programmes, 11 of which were&#xD;
        based in sub-Saharan Africa, but the quality of the evidence was generally very poor and too&#xD;
        heterogeneous for any sort of meta-analysis. In contrast to previous reviews, the grey&#xD;
        literature review found that the majority of programmes were not focused primarily on health,&#xD;
        covering more domains of the CBR Matrix (e.g. livelihoods, empowerment, education, etc.).&#xD;
        This suggests a disconnect between how CBR programmes are designed and evaluated to optimise&#xD;
        clinical outcomes for research purposes, versus how they are designed to meet pragmatic needs&#xD;
        in real-world practice.&#xD;
  &#xD;
        The SUCCEED pilot will use a before-and-after study design looking at changes in subjective&#xD;
        quality of life (WHOQOL-BREF) among participants with lived experience of psychosis who are&#xD;
        offered the SUCCEED intervention over a four-month follow-up period. Key components of the&#xD;
        SUCCEED intervention are peer support, case management and livelihoods activities, which are&#xD;
        delivered by a gender-mixed team including one peer support worker and one community support&#xD;
        worker embedded in a local organisation for persons with disabilities (OPD) in each SUCCEED&#xD;
        country.&#xD;
  &#xD;
        Nested within this pilot are three other components, described further in the full research&#xD;
        protocol (available upon request) :&#xD;
  &#xD;
          -  A baseline assessment of the feasibility and acceptability of WHOQOL-BREF as a&#xD;
             measurement tool (time taken to administer, proportion of participants who complete the&#xD;
             tool, perspectives of data collectors assessed through interviews), face validity&#xD;
             (assessed through cognitive interviewing) of WHOQOL-BREF, and the validity of proxy&#xD;
             (completed by a close family member) versus self-completion.&#xD;
  &#xD;
          -  A qualitative study using a combination of focus groups (participants with psychosis,&#xD;
             family members) and interviews (peer support workers, community support workers,&#xD;
             supervisors, data collectors) to further examine the acceptability and feasibility of&#xD;
             the SUCCEED's research and M&amp;E tools (including WHOQOL-BREF) and processes.&#xD;
  &#xD;
          -  A process evaluation drawing on semi-structured observations and routine monitoring and&#xD;
             evaluation (M&amp;E) of intervention delivery, competency assessment of the two frontline&#xD;
             providers (peer support workers and community support workers, via ENACT) research&#xD;
             administrative data (adverse events, drop-outs), and end-line qualitative data (see&#xD;
             above) to assess key process indicators and implementation outcomes (e.g. acceptability,&#xD;
             appropriateness, feasibility, fidelity, safety, etc.).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 18, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>This is a four-country pilot using a before-and-after study design to measure change in quality of life using the 26-item WHOQOL-BREF in participants with lived experience of psychosis who are offered the SUCCEED intervention (including case management, peer support and livelihoods activities) over a four-month follow-up period.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in self-reported Quality of Life (World Health Organisation Quality of Life Questionnaire Brief Version)</measure>
      <time_frame>Baseline and at 4 months follow up (endpoint)</time_frame>
      <description>WHOQOL-BREF has 26 items assessing individual's perception of their well-being over previous 2 weeks, across four domains (physical, psychological, social relationships and environment). Response to each item is rated against a 5-point Likert scale (1=not at all and 5=large amount). Scores are linearly transformed to total out of 100 where higher scores indicate better quality of life.&#xD;
  WHOQOL-BREF may be administered by a data collector in an interview format or self-completed (with data collector available for any assistance needed). We will also invite a close family member to complete the WHOQOL-BREF independently at baseline to investigate reliability of self- versus proxy-reported quality of life. Both participants with lived experience of psychosis and family members will be asked to complete a cognitive interview checking understanding of the questionnaire following completion of the WHOQOL-BREF at baseline.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Schizophrenia</condition>
    <condition>Schizoaffective Disorder</condition>
    <condition>Schizotypal Disorder</condition>
    <condition>Acute and Transient Psychotic Disorder</condition>
    <condition>Delusional Disorder</condition>
    <condition>Other Specified or Unspecified Primary Psychotic Disorder</condition>
    <condition>Bipolar Type I Disorder With Psychotic Symptoms</condition>
    <condition>Bipolar Type II Disorder With Psychotic Symptoms</condition>
    <condition>Single Episode Depressive Disorder With Psychotic Symptoms</condition>
    <condition>Recurrent Depressive Disorder With Psychotic Symptoms</condition>
    <condition>Perinatal Mental or Behavioural Disorder With Psychotic Symptoms</condition>
    <arm_group>
      <arm_group_label>SUCCEED Community-Based Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The SUCCEED community-based intervention (offering a combination of peer support, case management and livelihoods activities) will be delivered to 10 participants with lived experience of psychosis at each of the 4 pilot sites.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SUCCEED Community-Based Intervention</intervention_name>
      <description>The main components of the intervention are peer support, case management and livelihoods activities, delivered by a peer support worker and a community support worker. The peer support worker has lived experience of psychosis and draws on a variety of manualised tools and techniques adapted from previous studies. The community support worker mobilises families and communities to activate resources in support of participants (e.g., education and employment, social and recreational activities), drawing on established models of mental health case management and community-based inclusive development. The peer support worker and community support worker also run self-help groups for people with lived experience and their family members, respectively. Self-help group meetings are also used as an opportunity for group livelihoods activities taking an &quot;ABCD&quot; (asset-based community development&quot; approach.</description>
      <arm_group_label>SUCCEED Community-Based Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria:&#xD;
  &#xD;
          Participants with lived experience of psychosis must:&#xD;
  &#xD;
            -  Be consenting/assenting adults (age 18+)&#xD;
  &#xD;
            -  Be able to speak one of the main study languages: English, Chichewa, Krio, Shona,&#xD;
               Yoruba&#xD;
  &#xD;
            -  Live within the pilot study area&#xD;
  &#xD;
            -  Have a current or past diagnosis of schizophrenia or other primary psychotic disorder,&#xD;
               bipolar or depressive disorder with psychotic symptoms, or a maternal mental health or&#xD;
               behavioural disorder with psychotic symptoms, as per the World Health Organisation's&#xD;
               International Classification of Diseases Version 11 (see full list of eligible&#xD;
               diagnoses, below).&#xD;
  &#xD;
          For participants recruited from within the health care system, diagnosis will be confirmed&#xD;
          from health records. For those identified in the community, a research worker will&#xD;
          administer the World Health Organisation's Composite International Diagnostic Interview&#xD;
          (WHO CIDI) screening tool for psychosis.&#xD;
  &#xD;
          The following diagnoses are eligible for inclusion:&#xD;
  &#xD;
            -  Schizophrenia (6A20)&#xD;
  &#xD;
            -  Schizoaffective disorder (6A21)&#xD;
  &#xD;
            -  Schizotypal disorder (6A22)&#xD;
  &#xD;
            -  Acute and transient psychotic disorder (6A23)&#xD;
  &#xD;
            -  Delusional disorder (6A24)&#xD;
  &#xD;
            -  Other specified (6A2Y) or unspecified (6A2Z) primary psychotic disorder&#xD;
  &#xD;
            -  Bipolar type I disorder with psychotic symptoms (6A60.1, 6A60.5, 6A60.7, 6A60.A)&#xD;
  &#xD;
            -  Bipolar type II disorder with psychotic symptoms (6A61.3, 6A61.5)&#xD;
  &#xD;
            -  Single episode depressive disorder with psychotic symptoms (6A70.2, 6A70.4)&#xD;
  &#xD;
            -  Recurrent depressive disorder with psychotic symptoms (6A71.2, 6A71.4)&#xD;
  &#xD;
            -  Mental or behavioural disorder associated with pregnancy, childbirth or the&#xD;
               puerperium, with psychotic symptoms (6E21)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People who are currently homeless, for logistical reasons; the SUCCEED intervention&#xD;
               relies on PSWs and CSWs being able to regularly contact participants, including for&#xD;
               home visits.&#xD;
  &#xD;
            -  People with secondary psychotic syndromes (6E61), as these are considered to be the&#xD;
               direct consequences of physical health conditions as opposed to mental health&#xD;
               conditions.&#xD;
  &#xD;
            -  People diagnosed with a substance-induced psychotic disorder (6C40.6-6C47.6), as&#xD;
               recovery from substance use conditions is a specialist area outside the scope of the&#xD;
               SUCCEED intervention under development.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Professor Thomas Shakespeare</last_name>
      <role>Principal Investigator</role>
      <affiliation>London School of Hygiene and Tropical Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Dr Julian Eaton</last_name>
      <phone>+44 77 11140365</phone>
      <email>julian.eaton@lshtm.ac.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Grace Ryan</last_name>
      <phone>+44 7943224203</phone>
      <email>grace.ryan@lshtm.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Kamuzu University of Health Sciences</name>
        <address>
          <city>Blantyre</city>
          <state>Southern</state>
          <zip>0000</zip>
          <country>Malawi</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Janet Mambulasa</last_name>
        <phone>+265888894836</phone>
        <email>jmambulasa@kuhes.ac.mw</email>
      </contact>
      <investigator>
        <last_name>Anthony Sefasi</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Ibadan</name>
        <address>
          <city>Ibadan</city>
          <state>Oyo State</state>
          <zip>0000</zip>
          <country>Nigeria</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Dr Rita Tamambang</last_name>
        <phone>+234 8036811452</phone>
        <email>ritzfri@yahoo.com</email>
      </contact>
      <investigator>
        <last_name>Prof Olayinka Omigbodun</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Makeni</name>
        <address>
          <city>Makeni</city>
          <state>Northen Province</state>
          <zip>0000</zip>
          <country>Sierra Leone</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Veronica Ramatu Kamara</last_name>
        <phone>+232 79020049</phone>
        <email>veroalpha001@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Dr Rebecca Esliker</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University of Zimbabwe</name>
        <address>
          <city>Harare</city>
          <state>North East</state>
          <zip>0000</zip>
          <country>Zimbabwe</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ephiphania Munetsi</last_name>
        <phone>+263 777028347</phone>
        <email>epimunetsi1@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Prof Dixon Chibanda</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Malawi</country>
      <country>Nigeria</country>
      <country>Sierra Leone</country>
      <country>Zimbabwe</country>
    </location_countries>
    <link>
      <url>https://www.lshtm.ac.uk/research/centres-projects-groups/succeed</url>
      <description>Study webpage</description>
    </link>
    <reference>
      <citation>Hunt X, Abdurahman H, Omobowale O, Afolayan A, Munetsi E, Dzapasi L, Mokaya N, Koroma A, Barrie I, Ogunmola O, Koroma A, Shakespeare T, Eaton J, Ryan G. Interventions for adolescents and adults with psychosis in Africa: a systematic review and narrative synthesis. Glob Ment Health (Camb). 2022 May 27;9:223-240. doi: 10.1017/gmh.2022.25. eCollection 2022.</citation>
      <PMID>36618745</PMID>
    </reference>
    <reference>
      <citation>Omigbodun OO, Ryan GK, Fasoranti B, Chibanda D, Esliker R, Sefasi A, Kakuma R, Shakespeare T, Eaton J. Reprioritising global mental health: psychoses in sub-Saharan Africa. Int J Ment Health Syst. 2023 Mar 28;17(1):6. doi: 10.1186/s13033-023-00574-x.</citation>
      <PMID>36978186</PMID>
    </reference>
    <reference>
      <citation>Bella-Awusah T, Abdurahman H, Omobowale O, Aturu O, Afolayan A, Ogunmola O, Fasoranti B, Olusanmi M, Tamambang R, Bamidele O, Ryan G, Shakespeare T, Eaton J, Omigbodun O. Lessons of Hope and Resilience: A Co-Produced Qualitative Study of the Experiences of Youth Living with Psychosis During the COVID-19 Pandemic in Nigeria. Community Ment Health J. 2023 Jun 12:1-13. doi: 10.1007/s10597-023-01128-8. Online ahead of print.</citation>
      <PMID>37306804</PMID>
    </reference>
    <reference>
      <citation>Lee YY, Buyanga M, Mehta A, Omowunmi OA, Ryan G, Sunkel C, Vasquez A, Jones N. Cracks that Let the Light in: Collective Reflections on Integrating Lived Experience of Psychosis in Research and Policy in the Context of a Global Commission. Community Ment Health J. 2023 Jul;59(5):819-825. doi: 10.1007/s10597-023-01118-w. Epub 2023 Mar 20.</citation>
      <PMID>36939989</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Sub-Saharan Africa</keyword>
    <keyword>Psychosis</keyword>
    <keyword>Co-Production</keyword>
    <keyword>Peer support</keyword>
    <keyword>Human rights</keyword>
    <keyword>Nigeria</keyword>
    <keyword>Malawi</keyword>
    <keyword>Zimbabwe</keyword>
    <keyword>Sierra Leone</keyword>
    <keyword>Pilot trial</keyword>
    <keyword>Schizophrenia</keyword>
    <keyword>Community-based rehabilitation</keyword>
    <keyword>Livelihoods</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Schizophrenia</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
      <mesh_term>Schizophrenia, Paranoid</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Only anonymised data will be uploaded for archiving and data sharing. SUCCEED Data Access and Publication Policy stipulates that data are jointly owned by all SUCCEED partners; thus all partners are free to access anonymised SUCCEED data. Access is facilitated by the Data Management Team, which is comprised of nominated researchers at each site.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>After an 18-month embargo period, data are prepared for upload to LSHTM Data Compass site, in line with FCDO UK guidance on data sharing.</ipd_time_frame>
      <ipd_access_criteria>Any individual internal or external to SUCCEED may submit an expression of interest using a standardised online form outlining their intention to access and/or publish SUCCEED data; expressions of interest are reviewed on a regular basis by SUCCEED's five-country leadership team for approval. This is the main avenue by which SUCCEED ensures the use of data is for valid research. Once approved, those accessing the project data are required to sign a data access/confidentiality form.</ipd_access_criteria>
      <ipd_url>https://datacompass.lshtm.ac.uk/information.html</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007105
  org study id: 28346
  secondary id: EPPHZT74
  nct id: NCT06007105
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Although psychotic disorders typically affect less than 1% of the population, they are a
        significant cause of disability worldwide. Psychotic symptoms such as hallucinations,
        delusions and suicidal ideation can be profoundly disturbing, and negatively impact daily
        living. However, the social consequences of psychosis are often even more troubling than the
        symptoms. For example, people with psychosis have a high risk of experiencing violence,
        poverty, homelessness, incarceration, and unemployment, among other adverse outcomes.
  
        There is a need for a range of accessible, appropriate interventions for people with
        psychosis to be delivered to those in the most vulnerable situations, including in
        low-resource settings in sub-Saharan Africa. A systematic review recently carried out as part
        of the formative research for SUCCEED identified 10 studies evaluating the impact of
        interventions for people with psychosis in Africa, most of which had a strongly clinical
        focus. The review concluded that there was a need for further research involving people with
        lived experience of psychosis in designing and evaluating holistic interventions that meet
        their diverse needs, within and beyond the health sector.
  
        SUCCEED Africa is a six-year Health Research Programme Consortium (RPC) that has brought
        together people with lived experience of psychosis and people with professional experience
        (researchers, clinicians) from four African countries (Malawi, Nigeria, Sierra Leone,
        Zimbabwe) to co-produce a community-based intervention for psychosis, using a Theory of
        Change-driven approach. The SUCCEED intervention takes the World Health Organisation's
        (WHO's) CBR Matrix as a point of departure to consider the multifaceted needs of people
        living with psychosis and other psychosocial disabilities, and how best to meet these needs
        by mobilising the resources of individuals and families affected, as well as their broader
        communities.
  
        This protocol describes a pilot study in which the SUCCEED intervention will be delivered and
        evaluated on a small scale, in preparation for a larger multi-country research evaluation
        using more rigorous methods, including randomised controlled trials in Nigeria and Zimbabwe
        and observational studies in Malawi and Sierra Leone, respectively. The main outcome of
        interest is change in subjective quality of life among participants with lived experience of
        psychosis who are offered the intervention over a four-month follow up period.
  Recognising the need for a framework for interventions to support people with psychosocial
        disabilities in LMICs, the WHO's 2010 CBR Guidelines included a special supplement on mental
        health, which drew mainly from expert opinion, evidence in community mental health, and basic
        development principles, to make recommendations for best practice. However, a 2016 review
        examining CBR for disabilities in LMICs identified only one example of CBR for psychosocial
        disabilities in Sub-Saharan Africa. The authors concluded that there was a need for more
        evidence from this region, in particular.
  
        As part of SUCCEED Africa's formative research, a systematic review of the grey literature on
        CBR for psychosocial disabilities in LMICs was undertaken, in case there was in fact evidence
        available that had been excluded as a result of the previous review's strict eligibility
        criteria. The grey literature review identified 33 different CBR programmes, 11 of which were
        based in sub-Saharan Africa, but the quality of the evidence was generally very poor and too
        heterogeneous for any sort of meta-analysis. In contrast to previous reviews, the grey
        literature review found that the majority of programmes were not focused primarily on health,
        covering more domains of the CBR Matrix (e.g. livelihoods, empowerment, education, etc.).
        This suggests a disconnect between how CBR programmes are designed and evaluated to optimise
        clinical outcomes for research purposes, versus how they are designed to meet pragmatic needs
        in real-world practice.
  
        The SUCCEED pilot will use a before-and-after study design looking at changes in subjective
        quality of life (WHOQOL-BREF) among participants with lived experience of psychosis who are
        offered the SUCCEED intervention over a four-month follow-up period. Key components of the
        SUCCEED intervention are peer support, case management and livelihoods activities, which are
        delivered by a gender-mixed team including one peer support worker and one community support
        worker embedded in a local organisation for persons with disabilities (OPD) in each SUCCEED
        country.
  
        Nested within this pilot are three other components, described further in the full research
        protocol (available upon request) :
  
          -  A baseline assessment of the feasibility and acceptability of WHOQOL-BREF as a
             measurement tool (time taken to administer, proportion of participants who complete the
             tool, perspectives of data collectors assessed through interviews), face validity
             (assessed through cognitive interviewing) of WHOQOL-BREF, and the validity of proxy
             (completed by a close family member) versus self-completion.
  
          -  A qualitative study using a combination of focus groups (participants with psychosis,
             family members) and interviews (peer support workers, community support workers,
             supervisors, data collectors) to further examine the acceptability and feasibility of
             the SUCCEED's research and M&E tools (including WHOQOL-BREF) and processes.
  
          -  A process evaluation drawing on semi-structured observations and routine monitoring and
             evaluation (M&E) of intervention delivery, competency assessment of the two frontline
             providers (peer support workers and community support workers, via ENACT) research
             administrative data (adverse events, drop-outs), and end-line qualitative data (see
             above) to assess key process indicators and implementation outcomes (e.g. acceptability,
             appropriateness, feasibility, fidelity, safety, etc.).
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: This is a four-country pilot using a before-and-after study design to measure change in quality of life using the 26-item WHOQOL-BREF in participants with lived experience of psychosis who are offered the SUCCEED intervention (including case management, peer support and livelihoods activities) over a four-month follow-up period.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change in self-reported Quality of Life (World Health Organisation Quality of Life Questionnaire Brief Version)
  time frame: Baseline and at 4 months follow up (endpoint)
  description: WHOQOL-BREF has 26 items assessing individual's perception of their well-being over previous 2 weeks, across four domains (physical, psychological, social relationships and environment). Response to each item is rated against a 5-point Likert scale (1=not at all and 5=large amount). Scores are linearly transformed to total out of 100 where higher scores indicate better quality of life.
  WHOQOL-BREF may be administered by a data collector in an interview format or self-completed (with data collector available for any assistance needed). We will also invite a close family member to complete the WHOQOL-BREF independently at baseline to investigate reliability of self- versus proxy-reported quality of life. Both participants with lived experience of psychosis and family members will be asked to complete a cognitive interview checking understanding of the questionnaire following completion of the WHOQOL-BREF at baseline.
  arm group label: SUCCEED Community-Based Intervention
  arm group type: Experimental
  description: The SUCCEED community-based intervention (offering a combination of peer support, case management and livelihoods activities) will be delivered to 10 participants with lived experience of psychosis at each of the 4 pilot sites.
  intervention type: Behavioral
  intervention name: SUCCEED Community-Based Intervention
  description: The main components of the intervention are peer support, case management and livelihoods activities, delivered by a peer support worker and a community support worker. The peer support worker has lived experience of psychosis and draws on a variety of manualised tools and techniques adapted from previous studies. The community support worker mobilises families and communities to activate resources in support of participants (e.g., education and employment, social and recreational activities), drawing on established models of mental health case management and community-based inclusive development. The peer support worker and community support worker also run self-help groups for people with lived experience and their family members, respectively. Self-help group meetings are also used as an opportunity for group livelihoods activities taking an "ABCD" (asset-based community development" approach.
  arm group label: SUCCEED Community-Based Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Professor Thomas Shakespeare
  role: Principal Investigator
  affiliation: London School of Hygiene and Tropical Medicine
  last name: Dr Julian Eaton
  phone: +44 77 11140365
  email: julian.eaton@lshtm.ac.uk
  last name: Grace Ryan
  phone: +44 7943224203
  email: grace.ryan@lshtm.ac.uk
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Not yet recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Malawi
  country: Nigeria
  country: Sierra Leone
  country: Zimbabwe
  url: https://www.lshtm.ac.uk/research/centres-projects-groups/succeed
  description: Study webpage
  citation: Hunt X, Abdurahman H, Omobowale O, Afolayan A, Munetsi E, Dzapasi L, Mokaya N, Koroma A, Barrie I, Ogunmola O, Koroma A, Shakespeare T, Eaton J, Ryan G. Interventions for adolescents and adults with psychosis in Africa: a systematic review and narrative synthesis. Glob Ment Health (Camb). 2022 May 27;9:223-240. doi: 10.1017/gmh.2022.25. eCollection 2022.
  PMID: 36618745
  citation: Omigbodun OO, Ryan GK, Fasoranti B, Chibanda D, Esliker R, Sefasi A, Kakuma R, Shakespeare T, Eaton J. Reprioritising global mental health: psychoses in sub-Saharan Africa. Int J Ment Health Syst. 2023 Mar 28;17(1):6. doi: 10.1186/s13033-023-00574-x.
  PMID: 36978186
  citation: Bella-Awusah T, Abdurahman H, Omobowale O, Aturu O, Afolayan A, Ogunmola O, Fasoranti B, Olusanmi M, Tamambang R, Bamidele O, Ryan G, Shakespeare T, Eaton J, Omigbodun O. Lessons of Hope and Resilience: A Co-Produced Qualitative Study of the Experiences of Youth Living with Psychosis During the COVID-19 Pandemic in Nigeria. Community Ment Health J. 2023 Jun 12:1-13. doi: 10.1007/s10597-023-01128-8. Online ahead of print.
  PMID: 37306804
  citation: Lee YY, Buyanga M, Mehta A, Omowunmi OA, Ryan G, Sunkel C, Vasquez A, Jones N. Cracks that Let the Light in: Collective Reflections on Integrating Lived Experience of Psychosis in Research and Policy in the Context of a Global Commission. Community Ment Health J. 2023 Jul;59(5):819-825. doi: 10.1007/s10597-023-01118-w. Epub 2023 Mar 20.
  PMID: 36939989
  responsible party type: Sponsor
  mesh term: Schizophrenia
  mesh term: Depressive Disorder
  mesh term: Depression
  mesh term: Mental Disorders
  mesh term: Psychotic Disorders
  mesh term: Schizophrenia, Paranoid
  sharing ipd: Yes
  ipd description: Only anonymised data will be uploaded for archiving and data sharing. SUCCEED Data Access and Publication Policy stipulates that data are jointly owned by all SUCCEED partners; thus all partners are free to access anonymised SUCCEED data. Access is facilitated by the Data Management Team, which is comprised of nominated researchers at each site.
  ipd info type: Study Protocol
  ipd time frame: After an 18-month embargo period, data are prepared for upload to LSHTM Data Compass site, in line with FCDO UK guidance on data sharing.
  ipd access criteria: Any individual internal or external to SUCCEED may submit an expression of interest using a standardised online form outlining their intention to access and/or publish SUCCEED data; expressions of interest are reviewed on a regular basis by SUCCEED's five-country leadership team for approval. This is the main avenue by which SUCCEED ensures the use of data is for valid research. Once approved, those accessing the project data are required to sign a data access/confidentiality form.
  ipd url: https://datacompass.lshtm.ac.uk/information.html