Improving services for identifying and treating depression in primary healthcare clinics
ISRCTN | ISRCTN13462277 |
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DOI | https://doi.org/10.1186/ISRCTN13462277 |
Secondary identifying numbers | SPiRiT-D-NIHR203248 |
- Submission date
- 27/09/2024
- Registration date
- 07/10/2024
- Last edited
- 21/05/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
People attending primary or basic health facilities for any physical illnesses such as diabetes, hypertension, and heart disease are more likely to have depression. When people have both depression and physical illnesses, outcomes for both are worse, resulting in poorer health, quality of life, earlier deaths, and increased costs for individuals, families and healthcare services. Depression in people attending primary care, particularly in Pakistan, is usually not identified and treated. Collaborative care is a team approach in which healthcare workers in primary healthcare facilities (who are not mental health specialists) are trained to treat depression alongside physical illness. This study aims to implement collaborative care for depression in primary healthcare facilities in Karachi, Pakistan; and to test, in a trial, i) the effectiveness of collaborative care for treating depression, ii) the extent to which depression care is successfully implemented and iii) costs of collaborative care, compared to usual best practice. The study will also investigate the barriers and facilitators for implementing collaborative care, and how implementation can be improved.
Who can participate?
Participants aged 18 years or above, identified with depression, currently not taking any treatment for depression and attending SINA Health, Education and Welfare Trust primary care facilities in Karachi, Pakistan.
What does the study involve?
Twenty-four clinics will be randomly allocated to the intervention group (12 clinics) or the control group (12 clinics). Collaborative care will be implemented in the intervention clinics, while clinics in the control group will work according to best usual practice. Researchers will recruit about 30 patients per clinic; participants will be assessed at baseline and then 3, 6 and 12 months later to determine whether people in intervention clinics have better outcomes for depression, anxiety, physical health and quality of life, if collaborative care offers value for money, and how successfully it is implemented. Researchers will collect data from consenting participants on these variables, and will also use routinely collected data (including electronic patient records) from clinics.
What are the possible benefits and risks of participating?
The findings will benefit people with depression and physical illnesses, their caregivers, healthcare professionals, policymakers, and researchers. These results and recommendations will guide how to better identify and treat depression in primary care settings in Pakistan. This will enhance the management and treatment practices for individuals with depression who visit primary care facilities.
There are no significant additional risks involved in participating in the study. Those participants who will be taking antidepressants can experience adverse effects associated with using antidepressants. However, the physicians will use antidepressants which are already used in common practice, and their safety has been tested. Also, physicians will monitor any study participants on antidepressants, and experienced psychiatrists will supervise physicians. Participants may be asked about their experience of living with depression and physical illnesses, which may cause them to feel distressed, upset or uncomfortable.
Where is the study run from?
The study is led by the University of York (UK), The Aga Khan University (Pakistan), The Initiative, Islamabad (Pakistan), Institute of Psychiatry, Rawalpindi (Pakistan) and SINA Health, Education & Welfare Trust (Pakistan).
When is the study starting and how long is it expected to run for?
November 2022 to December 2026
Who is funding the study?
NIHR-Global Health Research Centre programme (UK)
Who is the main contact?
Prof. Najma Siddiqi, najma.siddiqi@york.ac.uk
Contact information
Principal Investigator
Department of Health Sciences
Room A/RRC/203b
ARRC Building
University of York
Heslington
York
YO10 5DD
United Kingdom
0000-0003-1794-2152 | |
Phone | +44 (0)1904 32 1681 |
najma.siddiqi@york.ac.uk |
Scientific
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
0000-0002-2725-572X | |
Phone | +44 (0)1904 32 2505 |
mehreen.faisal@york.ac.uk |
Public
Institute of Psychiatry
Murree Rd
Chah Sultan
Rawalpindi
46000
Pakistan
0000-0003-1061-6709 | |
Phone | +92 (0)317-1170359 |
mmb546@york.ac.uk |
Study information
Study design | Effectiveness-implementation hybrid type II cluster randomized controlled trial with an embedded economic and a mixed-methods process evaluation |
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Primary study design | Interventional |
Secondary study design | Cluster randomised trial |
Study setting(s) | Other |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | Strengthening primary care for recognising and treating depression (SPiRiT-D) |
Study acronym | SPiRiT-D |
Study objectives | Research Question 1: Is Collaborative Care effective for managing depression in primary care clinics? Research Question 2: How well is Collaborative Care successfully implemented? Research Question 3: Is the Collaborative Care model cost-effective for depression in primary care? Research Question 4: What are the contextual barriers and facilitators encountered in implementing the Collaborative Care model? Research Question 5: How do implementation strategies affect implementation outcomes? |
Ethics approval(s) |
1. Approved 24/05/2024, University of York Health Sciences Research Governance Committee (Department of Health Sciences, University of York, Heslington, York, YO10 5DD, United Kingdom; +44 (0)1904 323253/1; stephen.holland@york.ac.uk), ref: HSRGC/2024/626/H 2. Approved 23/09/2024, National Bioethics Committee, Pakistan (Health Research Institute, Shahrah-e-Jamhuriat, Off Constitution Avenue, Sector G-5/2, Islamabad, -, Pakistan; +92 (0)51 9224325, 9216793; nbcpakistan@nih.org.pk), ref: 4-87/NBC-1005/23/369 |
Health condition(s) or problem(s) studied | Depression |
Intervention | 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 is minimisation. In this method, clusters or individuals are randomly assigned to groups one at a time to achieve balance across different characteristics. In this trial, characteristics such as the availability of electronic health records (available/unavailable), mental health counsellor (available/unavailable), and clinic size (small/ medium/large) will be used for random clinic allocation using minimisation. Intervention: The intervention involves implementing a Collaborative Care model for depression in primary healthcare units. This model includes five key components: systematic identification of depression, provision and adjustment of evidence-based care (both antidepressants and brief behavioural treatment), tracking treatment outcomes, and weekly case review and supervision meetings. A Collaborative Care model for identifying and managing depression will be introduced in all intervention clinics using various implementation strategies. Control: Clinics randomised to the control group will follow optimised usual care. This includes information about depression, its management, and guidance on accessing local services. Participants will be assessed at baseline and then 3, 6 and 12 months later. |
Intervention type | Mixed |
Primary outcome measure | 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 outcome measures | 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 enrolled in the treatment of depression and “ne” represents the number of people eligible for such treatment 15. Treatment completion (TC) calculated using TC = tc/ te, where “tc” represents the number of people completed the depression treatment and “te” the number of people enrolled in such treatment 16. Treatment drop (TD) calculated using TD = td/ te, where “td” represents the number of people dropped out of the depression treatment and “te” the number of people enrolled in such treatment 17. Sustainability calculated using change in percentage from baseline to follow-up time-points in reach, adoption, treatment enrolment, completion, and dropout 18. Equity by comparing reach, adoption, treatment enrolment, completion, and dropout across different levels of socioeconomic status, gender, and ethnicity |
Overall study start date | 01/11/2022 |
Completion date | 31/12/2026 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 24 clinics (clusters), 30 participants per clinic and 720 overall |
Key inclusion criteria | 1. Attending primary care clinics 2. Aged 18 years or above 3. Score on PHQ-9 ≥10 |
Key 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 |
Date of first enrolment | 02/06/2025 |
Date of final enrolment | 31/10/2025 |
Locations
Countries of recruitment
- Pakistan
Study participating centres
Karachi
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Sponsor information
University/education
Research and Enterprise Directorate
Heslington
York
YO10 5DD
England
United Kingdom
Phone | +44 (0)1904 328693 |
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michael.barber@york.ac.uk | |
Website | https://www.york.ac.uk/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
Intention to publish date | 31/12/2027 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
Publication and dissemination plan | The research team has developed a comprehensive plan to publish their findings in high-impact, peer-reviewed journals. Additionally, the team plan to disseminate the findings in Pakistan through various means such as dissemination events, leaflets, infographics, posters, websites, and conference presentations. The Community Advisory Panel (CAP) will be regularly updated on the study's procedures and findings through scheduled meetings. |
IPD sharing plan | The chief investigator should be contacted for access to the datasets: Najma Siddiqi (najma.siddiqi@york.ac.uk). The type of data that will be shared is anonymised participant-level data (baseline [sociodemographic information] and follow-up [primary and secondary outcome] data). Data will be available after the publication of the main results and will be archived at the York Trials Unit indefinitely. Consent from participants would be obtained prior to enrollment in the study. All personally identifiable information will be removed from the database. There are no ethical or legal restrictions applicable. |
Editorial Notes
21/05/2025: The following changes were made to the study record:
1. The recruitment start date was changed from 19/05/2025 to 02/06/2025.
2. The recruitment end date was changed from 18/09/2025 to 31/10/2025.
23/04/2025: The following changes were made:
1. The recruitment start date was changed from 07/04/2025 to 19/05/2025.
2. The recruitment end date was changed from 06/08/2025 to 18/09/2025.
21/01/2025: The following changes were made:
1. The recruitment start date was changed from 01/01/2025 to 07/04/2025.
2. The recruitment end date was changed from 31/05/2025 to 06/08/2025.
3. The VPT Clinic, Hingora Goth Gadap Town Near New Sabzi Mandi in Karachi study participating centre was replaced with the Muhammad Jafar Ebrahim Center. The address of the VPT clinic at Govt Dispensary, Liyari 36 B, Khuda ki Basti Karachi was amended to Suhrab Goth Gadap Town.
27/09/2024: Study's existence confirmed by the University of York Health Sciences Research Governance Committee.