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CTRI Number  CTRI/2020/05/025048 [Registered on: 06/05/2020] Trial Registered Prospectively
Last Modified On: 10/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Behavioural Activation for Comorbid Depression in Non-communicable Disease (BEACON) study 
Scientific Title of Study   Behavioural activation for depression in people with non-communicable disease in low- and middle-income countries in South Asia: Protocol for intervention design and randomised controlled feasibility trial 
Trial Acronym  BEACON 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arun Kandasamy 
Designation  Additional professor  
Affiliation  NIMHANS 
Address  Dept of Psychiatry NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  08026995250  
Fax  08026564830  
Email  arunnimhans05@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arun Kandasamy 
Designation  Additional professor  
Affiliation  NIMHANS 
Address  Dept of Psychiatry NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  08026995250  
Fax  08026564830  
Email  arunnimhans05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Kandasamy 
Designation  Additional professor  
Affiliation  NIMHANS 
Address  Dept of Psychiatry NIMHANS

Bangalore
KARNATAKA
560029
India 
Phone  08026995250  
Fax  08026564830  
Email  arunnimhans05@gmail.com  
 
Source of Monetary or Material Support  
National Institute for Health Research, United Kingdom through the University of York, United Kingdom 
 
Primary Sponsor  
Name  Dr Arun Kandasamy 
Address  Additional Professor Dept of Psychiatry NIMHANS Bangalore KARNATAKA 560029 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Prof Pratima Murthy  Professor and Head of the Department Department of Psychiatry NIMHANS Hosur Road Bengaluru -29 
 
Countries of Recruitment     India
Pakistan
Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arun Kandasamy  Gownapall Community Health Center (CHC)  Room number - 05 Gownapalli Community health center (CHC)
Kolar
KARNATAKA 
08026995250

arunnimhans05@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee (Behavioural Sciences Division), NIMHANS, Bengaluru  Approved 
Ethics Committee (Behavioural Sciences Division), NIMHANS, Bengaluru  Approved 
Ethics Committee (Behavioural Sciences Division), NIMHANS, Bengaluru  Approved 
Ethics Committee (Behavioural Sciences Division), NIMHANS, Bengaluru   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E08-E13||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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BEACON intervention  Individual therapy, delivered by a trained health worker, supported by a treatment manual and workbooks, and supervision by a specialist 
Comparator Agent  Leaflet   The control group will receive a leaflet describing depression and its treatment, and signposting, including providing contact details (addresses and telephone numbers) to help access usual care for depression. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
A refined BA intervention, BEACON, including intervention manual, workbooks and training package, ready for trial intervention

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  
Outcome  TimePoints 
Anxiety (GAD-7)
Health related quality of life (EQ-5D-5L)
Physical health, using a measure of quality of life and function S(F-36)
NCD specific outcomes (HbA1c; Blood Pressure, respiratory quality of life) 
Baseline and 3 months
 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2020 
Date of Study Completion (India) 10/12/2021 
Date of First Enrollment (Global)  31/07/2020 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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.



 
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