Behavioural Activation for Comorbid Depression in Non-communicable Disease (BEACON) study

Completed

• Conditions: Diabetes mellitus, (2) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (3) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (4) ICD-10 Condition: F32||Major depressive disorder, singleepisode,

• Registration Number: CTRI/2020/05/025048
• Lead Sponsor: Dr Arun Kandasamy

Brief Summary

Background: The rising burden of depression and non-communicable disease multimorbidity is an increasing global challenge, largely neglected by healthcare services, particularly in low- and middle-income countries (LMIC). Coexistence of depression and chronic physical disease is common and worsens outcomes for both mental and physical disorder. Depression is amenable to treatment; effective interventions include a range of pharmacological and psychological therapies. Encouragingly for resource-constrained health systems, brief therapies, such as behavioural activation, have been shown to be as effective as more resource-intensive therapies for the treatment of depression in the general population. Several clinical guidelines recommend the use of these brief therapies, including for depression in people with physical health conditions. However, their feasibility and effectiveness for depression in patients with non-communicable diseases is not known**Aims:** We aim to adapt and test the feasibility of brief psychological therapy, behavioural activation, delivered by non-specialist health workers for people with depression in non-communicable diseases in LMIC in South Asia. Methods: Following the MRC framework for design and evaluation of complex interventions, we will first adopt the behavioural activation intervention to take account of contextual factors such as language and culture, resource constraints, infrastructure, staff capacity and training needs, scalability, and feasibility of integration within non-communicable disease services in Bangladesh, India and Pakistan.An expert panel will first identify how behavioural activation needs to be modified for delivery as part of current models of non-communicable disease care, informed by an assessment of the organisational capacity of healthcare services and focus groups and interviews with patients and healthcare providers. Co-design workshops and prototyping will then be used to iteratively adapt and refine the intervention content and materials 

Feasibility randomised controlled trial will be used to i) test acceptability, feasibility and implementation of the adapted intervention and refine our approach accordingly ii) test if an RCT can be delivered effectively and to estimate important parameters needed to design a randomised evaluation.  Findings will be used to refine procedures for a future definitive trial evaluation of effectiveness (and cost-effectiveness) of the adapted behavioural activation intervention compared with enhanced usual care for the treatment of depression in non-communicable diseases

**Community and public engagement:** Patients and the public will be involved throughout the study, including in the co-design workshops, design of the feasibility study and dissemination

**Dissemination**: We will engage end-users of our research, including policymakers and commissioners by holding knowledge transfer and dissemination events at key stages. We will prepare lay summaries and fact sheets of findings, distributed using social media, newspapers and a project website, alongside publications in academic journals to reach a range of audiences.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Study Completion: 2021-10-12
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

Aged 18 years or over Diagnosed with cardiovascular disease, chronic respiratory disease or diabetes (type 1 or 2) Current diagnosis of depression (confirmed with a clinician-administered PHQ-9 score of ≥ 10)48 Willing to participate and able to attend therapy sessions in person or by telephone Other mental or physical illness comorbidities will not be a reason to exclude unless the patient is judged to be too unwell to participate.

Exclusion Criteria

• Already receiving psychotherapy for depression.
• Being on antidepressant medication will not however be a reason to exclude.
• Lacking capacity to provide informed consent Unable to take part in therapy because of cognitive impairment, or severity of mental or physical illness.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A refined BA intervention, BEACON, including intervention manual, workbooks and training package, ready for trial intervention	Baseline and 3 months
An optimised protocol for evaluation of effectiveness and cost effectiveness of BEACON for depression in NCD in LMIC, including an intervention fidelity framework and protocols for process evaluation	Baseline and 3 months

Secondary Outcome Measures

Name	Time	Method
Anxiety (GAD-7)	Health related quality of life (EQ-5D-5L)

Trial Locations

Locations (1)

Gownapall Community Health Center (CHC); 🇮🇳 Kolar, KARNATAKA, India

Gownapall Community Health Center (CHC)

🇮🇳Kolar, KARNATAKA, India

Dr Arun Kandasamy

Principal investigator

08026995250

arunnimhans05@gmail.com