search
Back to results

Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan (PRIME-PK)

Primary Purpose

Depression, Self Harm

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
psychological interventions
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring treatment gap, mental health, primary care, task shifting, mhGap, Pakistan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients aged 18 and above presenting to recruiting health facilities will be assessed by the research team for depression (positive) and/or history of self-harm (positive Exclusion Criteria: Patients below 18 years of age, Patients taking medication for/ having a diagnosis of substance abuse, severe mental/physical disability/ comorbidity, whereby they are unable to participate in the interview.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    mgGap-IG

    Arm Description

    MhGap-IG intervention to be delivered to depression and self-harm cohorts

    Outcomes

    Primary Outcome Measures

    Piloting log to record number of patients with depression and or self-harm episode, treatment initiated and patients referred
    Culturally Adapted Manual Assisted Problem Solving Intervention (CMAP) - This intervention is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of CBT

    Secondary Outcome Measures

    Patient Health Questionnaire
    This is a10 item questionnaire with a total score ranging from 1-4 indicates minimal depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. A cut-off score of 10 and above indicate high likelihood of presence of depression.
    Generalised Anxiety Disorder scale
    This is a 7-item scale. GAD-7 total score for the seven items ranges from 0 to 21.0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety. A cut-off score of 10 and above indicate high likelihood of presence of anxiety.
    Deliberate Self-Harm Inventory
    DSHI will be used to collect information about episode of self-harm. is a 17-item self-report questionnaire developed to assess deliberate self-harm. It is behaviorally based and assesses aspects of deliberate self-harm such as frequency, severity, duration, and type of self-harming behavior
    Oslo - 3 items social support scale
    Oslo-3 social support scale is a short three item rating scale. This scale assesses relationship with friends, family and neighbors. Each item is scored on a 5-point rating scale, and the total score ranges from 3 to 15, with high scores indicating greater level of support.
    Life Events Checklist
    The domains that accounted for most of the life events and difficulties will be included and rated categorically as present or not in the previous 12 months.
    EuroQoL-5 Dimensions
    This is a standardized instrument to measure health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression)
    Client Services Receipt Inventory
    Participants will be asked to give a detailed description of the use of health services (including the informal sector faith healers/Imams) in last 3 months.

    Full Information

    First Posted
    February 28, 2023
    Last Updated
    August 25, 2023
    Sponsor
    Pakistan Institute of Living and Learning
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05767840
    Brief Title
    Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan
    Acronym
    PRIME-PK
    Official Title
    Development and Pilot Testing of an Integrated Mental Healthcare Plan for Management of Depression and Self-harm in a Rural District (Thatta) in Pakistan
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Pakistan Institute of Living and Learning

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aims: To describe the process of developing a feasible district mental healthcare plan (MHCP) for depression, self-harm and suicide prevention, and To describe its enabling intervention packages and components to be delivered at the Basic Health Units in Thatta district. The proposed study will be a pilot implementation with nested qualitative component. The study will also involve situational analysis for proposed study site and Theory of Change workshops with key stakeholders. This study is a replication of the methods used in the development of a district mental healthcare plan in Uganda (Kigozi et al., 2016).
    Detailed Description
    Mental neurological and substance use (MNS) disorders contribute significantly to global burden of disease. The WHO Mental Health Action Programme (MhGAP) taking a life course approach has developed an intervention guide to scale up services in low and middle income countries (LMICs) focusing on priority mental health conditions in adults and older adults. The gap between the individuals in need of mental health interventions and those who actually receive such care remains very large. To reduce the treatment gap, the WHO Mental Health Action Plan (WHO, 2017) strongly recommended assessment, diagnosis and treatment of MNS in community settings and primary healthcare (PHC). Central to this agenda is the WHO Mental Health Gap Action Programme (mhGAP) and intervention guide (IG) (WHO, 2010) which is an evidence based tool. The proposed project aims to integrate the adapted WHO-mhGap-IG for depression, self-harm and suicide prevention into the community and primary settings in Thatta (situated in the province of Sindh, Pakistan). Depression and self-harm are selected priority conditions for the proposed study. In order to collect information and detailed cross-sectional data on health and factors that can influence health of Thatta district, a situational analysis tool will be used. Both one to one in-depth interviews as well as focus groups will be conducted with stakeholders to explore possible barriers and facilitators of testing the feasibility of adapted mhGap-IG for depression and self-harm in Thatta. Pilot study will be conducted using the mhGAP-Intervention Guide (mhGAP-IG) (two modules: Depression, self harm and suicide prevention)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression, Self Harm
    Keywords
    treatment gap, mental health, primary care, task shifting, mhGap, Pakistan

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    mgGap-IG
    Arm Type
    Experimental
    Arm Description
    MhGap-IG intervention to be delivered to depression and self-harm cohorts
    Intervention Type
    Other
    Intervention Name(s)
    psychological interventions
    Other Intervention Name(s)
    mhGap-IG
    Intervention Description
    mhGap-IG Depression and self-harm module. For participants identified as has having depression, following interventions will be offered depending on nature of the participants. Khushi Aur Khatoon - for the treatment of depression and anxiety Learning through Play Plus - 10-session group intervention that integrates parental information about child development and Cognitive Behavior Therapy Problem management Plus (PM+) - PM+ is for adults suffering from symptoms of common mental health problems , as well as self-identified practical problems. Cohort identified as having a recent history of self-harm will receive; Culturally Adapted Manual Assisted Problem Solving Intervention (CMAP) - This intervention is a manual-assisted intervention, adapted from a self-help guide called Life After Self-Harm.
    Primary Outcome Measure Information:
    Title
    Piloting log to record number of patients with depression and or self-harm episode, treatment initiated and patients referred
    Description
    Culturally Adapted Manual Assisted Problem Solving Intervention (CMAP) - This intervention is a manual-assisted intervention which has been adapted from a self-help guide called Life After Self-Harm based on the principles of CBT
    Time Frame
    Recruitment From First month of study to the end of thirst month of the study start date.
    Secondary Outcome Measure Information:
    Title
    Patient Health Questionnaire
    Description
    This is a10 item questionnaire with a total score ranging from 1-4 indicates minimal depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, and 20-27 severe depression. A cut-off score of 10 and above indicate high likelihood of presence of depression.
    Time Frame
    Change in scores from baseline to 3rd-month follow-up on PHQ-9
    Title
    Generalised Anxiety Disorder scale
    Description
    This is a 7-item scale. GAD-7 total score for the seven items ranges from 0 to 21.0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety. A cut-off score of 10 and above indicate high likelihood of presence of anxiety.
    Time Frame
    Change in scores from baseline to 3rd-month follow-up on GAD-7
    Title
    Deliberate Self-Harm Inventory
    Description
    DSHI will be used to collect information about episode of self-harm. is a 17-item self-report questionnaire developed to assess deliberate self-harm. It is behaviorally based and assesses aspects of deliberate self-harm such as frequency, severity, duration, and type of self-harming behavior
    Time Frame
    Repetition of a self-harm episode from baseline to end of 3rd month post-baseline
    Title
    Oslo - 3 items social support scale
    Description
    Oslo-3 social support scale is a short three item rating scale. This scale assesses relationship with friends, family and neighbors. Each item is scored on a 5-point rating scale, and the total score ranges from 3 to 15, with high scores indicating greater level of support.
    Time Frame
    Change in scores from baseline to 3rd-month follow-up on social support
    Title
    Life Events Checklist
    Description
    The domains that accounted for most of the life events and difficulties will be included and rated categorically as present or not in the previous 12 months.
    Time Frame
    Number of stressful events identified by each participant as present in last 12 months
    Title
    EuroQoL-5 Dimensions
    Description
    This is a standardized instrument to measure health-related quality of life. It consists of a self-report questionnaire covering five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression)
    Time Frame
    Change in scores from baseline to 3rd-month follow-up on EQ-5D
    Title
    Client Services Receipt Inventory
    Description
    Participants will be asked to give a detailed description of the use of health services (including the informal sector faith healers/Imams) in last 3 months.
    Time Frame
    Change in health service utilization from baseline to 3 month follow-up recorded through CSRI

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patients aged 18 and above presenting to recruiting health facilities will be assessed by the research team for depression (positive) and/or history of self-harm (positive Exclusion Criteria: Patients below 18 years of age, Patients taking medication for/ having a diagnosis of substance abuse, severe mental/physical disability/ comorbidity, whereby they are unable to participate in the interview.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tayyeba Kiran
    Phone
    02135871845
    Email
    tayyaba.kiran@pill.org.pk

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Only anonymized data will be shared on request
    Citations:
    PubMed Identifier
    26447171
    Citation
    Kigozi FN, Kizza D, Nakku J, Ssebunnya J, Ndyanabangi S, Nakiganda B, Lund C, Patel V. Development of a district mental healthcare plan in Uganda. Br J Psychiatry. 2016 Jan;208 Suppl 56(Suppl 56):s40-6. doi: 10.1192/bjp.bp.114.153742. Epub 2015 Oct 7.
    Results Reference
    background

    Learn more about this trial

    Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan

    We'll reach out to this number within 24 hrs