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
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
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
NCT ID
NCT05767840
First Posted
February 28, 2023
Last Updated
August 25, 2023
Sponsor
Pakistan Institute of Living and Learning
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
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