Depression Clinical Trial
— PRIME-PKOfficial 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
Verified date | May 2024 |
Source | Pakistan Institute of Living and Learning |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | September 30, 2024 |
Est. primary completion date | April 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. |
Country | Name | City | State |
---|---|---|---|
Pakistan | District health facility | Thatta | Sindh |
Lead Sponsor | Collaborator |
---|---|
Pakistan Institute of Living and Learning |
Pakistan,
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
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 |
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