Depression Mental and Behavioural Disorders
Conditions
Interventions
Twenty-four clinics will be randomised in a 1:1 ratio to either of two arms: i) intervention and ii) control. The method of randomising clinics (clusters) either to the intervention or control group i
Sponsors
University of York
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Attending primary care clinics 2. Aged 18 years or above 3. Score on PHQ-9 =10
Exclusion criteria
Exclusion criteria: 1. Participants already receiving any kind of psychological therapy 2. Participants lacking the capacity to provide informed consent, or not willing to consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effectiveness: Depression severity (mean change) will be measured using Patient Health Questionnaire-9 (PHQ-9) at the 6-month timepoint. 2. Implementation: Reach of depression treatment (RT) using RT= st/ne, where "st" represents the number of individuals who participated in the treatment for depression and "ne" represents the number of people eligible for such treatment at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcomes related to clinical effectiveness will be measured at the participant level during follow-ups at 3, 6, and 12 months, unless otherwise specified below: 1. Body mass index (BMI) calculated using the formula: BMI = weight (kg) / height (m²), where height is measured in meters and weight is measured in kilograms 2. Blood pressure measured using an automated blood pressure instrument 3. Waist circumference measured in centimetres 4. Depression severity measured using PHQ-9 at 3 and 12 months 5. Depression caseness measured using PHQ-9 6. Anxiety caseness and severity measured using Generalised Anxiety Disorder Questionnaire (GAD-7) 7. Quality of life measured using Euroqol's instrument EQ-5D-5L at 6 and 12 months 8. Functional impairment measured using the WHO Disability Assessment Schedule (WHODAS 2.0) at 6 and 12 months 9. Healthcare resource measured using modified Client Service Receipt Inventory (CSRI) at 6 and 12 months 10. Adverse events measured using a modified adverse event The following clinic-level aggregated secondary outcomes related to implementation effectiveness will be calculated at 3, 6, and 12 months follow-up timepoints, unless otherwise specified below: 11. Reach of screening (RS) calculated using the formula RS = sd/nc, where "sd" represents the number of individuals screened for depression and "nc" denotes the total number of individuals attending the clinics 12. Reach of depression treatment (RT) calculated using RT = st/ ne, where “st” represents the number of individuals who participated in the treatment for depression and “ne” represents the number of people eligible for such treatment at 3 and 12 months 13. Adoption (AD) calculated using AD = r/ nr, where “r” denotes the number of people referred for the treatment of depression and “nr” denotes the number of people eligible for referrals at 6, and 12 months 14. Treatment enrolment (TE) calculated using TE = te/ ne, where “te” represents the number of people | — |
Countries
Pakistan
Contacts
Public ContactMujeeb Bhatti
Outcome results
None listed