Condition category
Mental and Behavioural Disorders
Date applied
02/10/2013
Date assigned
07/10/2013
Last edited
02/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression accounts for the highest burden of disease of any mental disorder. Most patients with depression seek healthcare through their GP surgeries. The WHO recommends the use of psychoeducation for mild depression and antidepressant drugs or psychological treatments (PT) for moderate to severe depression. Antidepressants are useful only for a third to half of patients with depression. People do not adhere to this treatment, it has high relapse rates, and is not routinely available in GP surgeries. A major hurdle to the implementation of PT in GP practices of developing countries is the lack of skilled human resources. The aim of this study is to find out the effectiveness and cost-effectiveness of the Healthy Activity Program (HAP).

Who can participate?
Adults with moderate/severe depression can participate in this study.

What does the study involve?
Participants with moderate to severe depression will be identified by screening. Eligible participants will be randomly allocated to receive either enhanced usual care (EUC) or EUC plus HAP. The EUC will comprise providing PHC doctors with the contextualised WHO guidelines and the results of the patient health questionnaire. Participants in the HAP group will receive, in addition to EUC, an eight-session PT delivered by trained and supervised lay counsellors, over a maximum period of 3 months. This PT has been systematically developed based on evidence and includes psychoeducation, problem-solving, behavioural activation (BA) and relaxation training.

What are the possible benefits and risks of participating?
Participants will receive the counselling sessions from a trained counsellor along with doctor’s treatment at no extra cost. If our study finds that adding counselling makes treatment more effective, this will help us work with the government to make counselling available in clinics across Goa and India. We do not expect any risks from taking part, apart from the fact that patients may find discussing their health and personal problems to be distressing. In our experience, most people do not experience such feelings. Patients are however assured that our counsellors and researchers have been trained to handle such situations and if required, services of other health experts will be made available.

Where is the study run from?
The study will be conducted in eight primary health centres (PHCs) in the North district of Goa, India

When is study starting and how long is it expected to run for?
October 2013 to October 2015

Who is funding the study?
The Wellcome Trust (UK)

Who is the main contact?
Prof. Vikram Patel
+91 (0)9822132038
vikram.patel@lshtm.ac.uk

Trial website

http://www.sangath.com/details.php?nav_id=123

Contact information

Type

Scientific

Primary contact

Prof Vikram Patel

ORCID ID

http://orcid.org/0000-0003-1066-8584

Contact details

Faculty of Epidemiology and Population Health
Department of Population Health
Keppel Street
London
WC1E 7HT
United Kingdom
+91 (0)9822132038
vikram.patel@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled trial of the effectiveness and cost-effectiveness of the Healthy Activity Program (HAP), a lay counsellor-delivered psychological treatment for moderate to severe depression in primary care in India

Acronym

PREMIUM

Study hypothesis

Primary hypotheses:
1. The HAP intervention in addition to enhanced usual care (EUC) will be superior to EUC alone in reducing the symptoms of depression.
2. The HAP intervention in addition to EUC will be superior to EUC alone in increasing remission rates, at 3 months post-enrolment.

Secondary hypotheses:
The HAP intervention in addition to EUC will be superior to EUC alone in the following respects:
1. Reducing depression scores and increasing remission rates at 12 months post enrolment
2. Reducing disability levels at 3 months and at 12 months post enrolment
3. Reducing costs of illness over 12 months (thus, being 'dominant' in economic terms)
4. Reducing suicidal behaviour over 12 months

The rationale for the 12-month review is to evaluate the longer-term impact of the intervention, in the context of the high relapse rates of depression, particularly in patients who receive only antidepressant medication.

Ethics approval

1. Interventions Research Ethics Committee - London School of Hygiene and Tropical Medicine (6507)
2. Sangath Institutional Review Board - Sangath, India

Study design

Parallel-arm individually randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

General adult depression

Intervention

Patients are randomised to receive either HAP or EUC.

The Health Activity Program (HAP):
The psychological treatment was named the Healthy Activity Program and consisted of up to eight sessions in three flexible phases delivered over 2-3 months with each session lasting between 30 and 45 minutes. Any patient receiving eight sessions of HAP or achieving a prior clinical recovery criteria will be considered to have completed the treatment. Patients who do not respond to HAP at the end of eight sessions will receive a referral to psychiatric services. Any patient missing two consecutive scheduled sessions will be considered as a treatment drop out. However, patients who re-engage at any point during the trial will be offered the opportunity to continue from the last session.

HAP will be delivered by lay counsellors who are members of the local community, are above 18 years of age, completed at least high school education and who do not have any professional mental health training, and have an expressed desire to help people with mental health problems. Trainee counsellors were recruited by placing advertisements in newspapers and through word of mouth. Trainees were selected based on their performance in a structured interview and role play. Post selection, the trainees underwent a three-week participatory workshop (which also covered the drinking problems treatment). Trainees who met competency standards (based on role play and multiple choice questions) progressed to the pilot study. Training was conducted by mental health professionals who were closely involved in the development of HAP. During the pilot study the trainee counsellors delivered HAP to eligible patients in PHCs. Supervision was carried out both in individual and weekly group format. Therapy quality was assessed mainly through rating of audio-taped sessions using a specially developed scale, the Quality of HAP (Q-HAP), adapted from the Counselling Skills Scale (CSS) and Quality of Behavioural Activation Scale (Q-BAS), which itself is modelled after the 'cognitive therapy scale' and modified to apply to the strategies used in BA. As the trainee counsellors gained experience in delivering the intervention the supervision format evolved from expert-led (i.e. local mental health professionals skilled in the delivery of HAP) to peer-led group supervision. Only trainees who achieved competence, as assessed by standardised role plays and therapy quality assessments, have been selected to deliver HAP in the trial. Each PHC will have one counsellor, with a pool of back-up counsellors in the event of attrition (for e.g. due to counsellors leaving for other opportunities).

Enhanced Usual Care:
Usual care for depressive disorders in India is, in effect, no care at all. This has been confirmed in the study setting during the pilot study. This is primarily because most cases are not diagnosed and, amongst those who are, most do not receive either antidepressants or psychological treatments. In PREMIUM, usual care is enhanced in the following ways:
1. Provision of the screening results for depression to the primary care physician
2. Provision of a contextualized version of the mhGAP guidelines for depression to the primary care physician, including explicit guidelines on when and where to refer patients for psychiatric care.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Mean difference in total score measured by the Beck's Depression Inventory (BDI-II), at 3 months , a 21-item questionnaire assessment of depressive symptoms; each item is scored on a Likert scale of f 0 to 3. It measures depression severity based on symptom scores.
2. Remission, defined as a score of <10 measured at 3 months by the Patient Health Questionnaire (PHQ-9), a nine-item questionnaire for the detection and diagnosis of depression based on DSM-IV criteria. It is scored on a scale of 0 to 3 based on frequency of symptoms.

Secondary outcome measures

1. Mean difference in total score measured by the Beck's Depression Inventory (BDI-II) at 12 months
2. Remission defined as a score of <10 on the Patient Health Questionnaire (PHQ-9) at 12 months
3. Mean difference in disability score measured by the World Health Organisation Disability Assessment Schedule (WHODAS) at 3 and 12 months, a 12-item questionnaire for measuring functional impairment over the previous 30 days. In addition, two items assess number of days the person was unable to work in the previous 30 days.
4. Costs of illness (direct and indirect) measured by the Client Service Receipt Inventory at 3 and 12 months, a questionnaire to collect data on the utilisation and costs of health care and lost productivity (including that of care-givers)
5. Suicidal thoughts or attempts: assessed with item 9 of the PHQ-9 and with an additional question on suicide attempts at 12 months, based on interviews used to assess suicidal behaviour in earlier studies in Goa
6. Experience of intimate partner violence at 3 and 12 months, based on questions used in an earlier study of women's mental health in Goa
7. Level of activation based on an adapted version of the Behavioural Activation for Depression Scale- short form (BADS-SF) assessed within the last week at 3 and 12 months
8. Other secondary outcomes: change in marital status, employment status, based on a sociodemographic questionnaire at 3 and 12 months

Overall trial start date

28/10/2013

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Must be above the age of 18 but below the age of 65
2. Must reside within the geographic area which is selected for the PHC
3. Must plan to stay at the same address for at least 12 months
4. Must be able to speak one of the following languages: Konkani/Hindi/Marathi/English
5. Must not have been screened in the previous 3 months

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

450

Participant exclusion criteria

1. Pregnant women
2. Patients with drinking problems (as the guidelines require such patients to be treated first for drinking problems and this will be handled in a companion trial)
3. Patients who need urgent medical attention (defined as needing emergency treatment and/or in-patient admission)
4. Patients unable to communicate clearly (for example due to a speech or hearing disability)
5. In receipt of PREMIUM counselling treatment

Added 26/05/2015:
6. Patient lives together in the same household with previously recruited patient or is in regular contact with previously recruited patient(s)

Recruitment start date

28/10/2013

Recruitment end date

31/07/2015

Locations

Countries of recruitment

India

Trial participating centre

8 primary healthcare clinics in north Goa
-
India

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7636 8636
michael.robinson@lshtm.ac.uk

Sponsor type

University/education

Website

http://www.lshtm.ac.uk

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) Grant Ref no: 091834/Z/10/Z

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

A multi-modal dissemination plan is envisaged. This will seek to share findings in different formats with a wide constituency of user communities. These strategies will mainly include scientific publications and policy briefs. The scientific publications will be in open-access format, and the main report of the trials is scheduled to be submitted six months after data collection is complete and the database is cleaned and locked. Dissemination strategies will also include compilation of treatment manuals which are already available and accessible on the website (see http://sangath.com/manuals.php), workshops with health officials/staff from the Primary Health Care clinics and Health Directorate of Goa, and community meetings.

IPD sharing plan:
The dataset contains redacted participant level records of adult male/female PHC attendees (one patient per row) recruited in the trials site between 28/10/2013 and 30/07/2015, and followed-up for outcome assessments till 01/09/2016. The datasets encompass: enrolment, treatment process (including therapy quality), and outcome data.

Repository name:
1. London School of Hygiene and Tropical Medicine (LSHTM) Data Compass
2. Sangath project data folder (intranet)

Persistent weblink: http://datacompass.lshtm.ac.uk

In compliance with the Wellcome Trust policy on data management and sharing, and the access options supported at the London School of Hygiene and Tropical Medicine, managed access at the level of ‘restricted’ will be used, backed by a licence based on ‘open data commons’ model. This means anyone can freely access, use, modify, and share for any purpose (subject, at most, to requirements that preserve provenance and openness), but requests for data access will have to be made through completing a formal request form to the principal investigator - Professor Vikram Patel (vikram.patel@lshtm.ac.uk).

The curated raw trial data, in addition to the variable codebook will be deposited in the named repository by 31/12/2017, and will remain available to the public for the next 10 years.

Informed consent was obtained from participants. Participants were made to understand that the data collected will be used for only research purposes and persons not directly involved in the study will not have access to the data in order to uphold confidentiality. Participants were also assured that all identifying information will be removed when publishing findings of the study.

Data will be redacted to ensure both direct and indirect identifiers are not shared.

Intention to publish date

30/09/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24690184
Statistical analysis plan: http://sangath.com/images/file/PREMIUM%20statistical%20analysis%20plan%20FINAL%20171215.pdf
Statistical analysis plan for 12-month outcomes:
http://www.sangath.com/images/file/PREMIUM%2012month%20statistical%20analysis%20plan%20FINAL%208%207%202016.pdf

Publication citations

  1. Protocol

    Patel V, Weobong B, Nadkarni A, Weiss HA, Anand A, Naik S, Bhat B, Pereira J, Araya R, Dimidjian S, Hollon SD, King M, McCambridge J, McDaid D, Murthy P, Velleman R, Fairburn CG, Kirkwood B, The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials., Trials, 2014, 15, 101, doi: 10.1186/1745-6215-15-101.

Additional files

Editorial Notes

02/11/2016: IPD sharing plan added. 03/10/2016: link to statistical analysis plan added. 26/05/2015 the following changes were made to the trial record: 1. The target number of participants was changed from 500 to 450. 2. The overall trial start date was changed from 14/10/2013 to 28/10/2013. 3. The overall trial end date was changed from 31/10/2015 to 30/09/2016.