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

Depression Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05767840
• Other study ID #: PRIME-PK
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2023
• Source: Pakistan Institute of Living and Learning
• Contact: Tayyeba Kiran
• Phone: 02135871845
• Email: tayyaba.kiran[@]pill.org.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Self Harm
• Self-Injurious Behavior

Intervention

Other:
• psychological interventions
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recruitment From First month of study to the end of thirst month of the study start date.
Secondary	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.	Change in scores from baseline to 3rd-month follow-up on PHQ-9
Secondary	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.	Change in scores from baseline to 3rd-month follow-up on GAD-7
Secondary	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	Repetition of a self-harm episode from baseline to end of 3rd month post-baseline
Secondary	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.	Change in scores from baseline to 3rd-month follow-up on social support
Secondary	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.	Number of stressful events identified by each participant as present in last 12 months
Secondary	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)	Change in scores from baseline to 3rd-month follow-up on EQ-5D
Secondary	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.	Change in health service utilization from baseline to 3 month follow-up recorded through CSRI