| 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
|
|
|
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 knownAims: 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.
|