Clinical trial NCT05767840: Integrated Mental Healthcare Plan for Management of Depression and Self-harm in Pakistan
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Self Harm
Keywords: treatment gap
mental health
primary care
task shifting
mhGap
Pakistan
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aims:

1. To describe the process of developing a feasible district mental healthcare plan (MHCP) for depression, self-harm and suicide prevention, and
2. 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)

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.

Primary outcomes:
measure: Piloting log to record number of patients with depression and or self-harm episode, treatment initiated and patients referred
timeFrame: Recruitment From First month of study to the end of thirst month of the study start date.
Secondary outcomes:
measure: Patient Health Questionnaire
timeFrame: Change in scores from baseline to 3rd-month follow-up on PHQ-9
measure: Generalised Anxiety Disorder scale
timeFrame: Change in scores from baseline to 3rd-month follow-up on GAD-7
measure: Deliberate Self-Harm Inventory
timeFrame: Repetition of a self-harm episode from baseline to end of 3rd month post-baseline
measure: Oslo - 3 items social support scale
timeFrame: Change in scores from baseline to 3rd-month follow-up on social support
measure: Life Events Checklist
timeFrame: Number of stressful events identified by each participant as present in last 12 months
measure: EuroQoL-5 Dimensions
timeFrame: Change in scores from baseline to 3rd-month follow-up on EQ-5D
measure: Client Services Receipt Inventory
timeFrame: Change in health service utilization from baseline to 3 month follow-up recorded through CSRI
Other outcomes:
Locations:
city: Thatta
country: Pakistan
facility: District health facility
state: Sindh
Study officials:
References:
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.