1. Trimbos Institue, Netherlands
ATMIYATA: Testing effectiveness of counselling delivered by community volunteers to people with common mental health issues in rural parts of Gujarat, India: Step Wedged Cluster Randomized Trial (SWCRT)
Dr Kaustubh Joag, Dr Soumitra Pathare, Dr Deepa Pandit, Ms Jasmine Kalha
Center for Mental health law and policy, Indian Law Society, Pune, India
Dr Laura Shield Zeeman
Trimbos Institue, Netherlands

2. Background Mental ill health is substantial public health burden
- 8% of Indian population have common mental health issues direct effect on once productivity and social participation
Poor access to mental health care or large treatment gap
- Stigma and discrimination
- lack of awareness
- lack of professional resources particularly in rural area

3. Setting Rural parts in a district of state Gujarat
600 villages; 1 million adult population
Agriculture and cattle rearing; caste division, politically active
Public health services are functional
District mental health programme is active

4. Atimiyata- Community based intervention
What Atmiyata does
- Select and train community volunteers (Champions) from each village
- Support, monitor and mentor them to build their capacity
What Champions do
- Identify and counsel / support people with common mental health issues
- refer people with severe mental health issues to public health system
- facilitate social benefits for people with mental disability
- raise community awareness by using films loaded on smart phones; films are based on social causes of mental health issues like domestic violence and unemployment.

5. Stepped Wedge Cluster Randomized Trial
Study population – People with common mental health issues receiving basic counseling from champions against people with common mental health issues not receiving the counseling and having usual care.
Objectives –
- To study reduction of symptoms
- To study reduction of disability
- To stud improvement in social participation

6. Study Design: sw-CRT Clusters Period 1 Period 2 Period 3 Period 4
Cluster 1 (14 Health Centers)
Intervention rolled out
Cluster 2 (14 Health Center)
Cluster 3 (14 Health Centers)
Cluster 4 (14 Health Centers)

7. Reason for choosing SW CRT
Logistically, rolling out a large scale public health intervention at one point is not possible
Community viewpoint- sw-CRT is more acceptable
Sometime politically it becomes mandatory to start the intervention from specified geographical area due to political pressure
sw-CRT allows implementation to get more refined at each step and learn as you go.
Prost et al, Logistic, ethical, and political dimensions of stepped wedge trials: critical review and case studies. Trials 2015 Aug 17;16:351. doi: /s
Gallo A, Weijer C, White A, Grimshaw JM, Boruch R, et al. (2012) What is the role and authority of gatekeepers in cluster randomized trials in health research? Trials 13: 116
as everyone will get an intervention at the end of trial.

8. Commentary

9. Gatekeeper permission
The district has 56 health centers; divided into 4 clusters ; Each cluster has 14 health centers
Each health center covers villages
Atmiyata intervention happens at village level and we have linkages with health center too.
Choice of gatekeeper’s - from each village - we chose village heads or community or religious leaders

10. Rule of randomization
In our case, we choose a cluster as first cluster to go for an intervention after a suggestion from an administrator and politician
We have a collaboration with Government
Suggestion came in one of the meeting before starting the project

11. Dilemma about clinical equipoise
Atmiyata intervention use basic counseling technique which is proven to be effective for people with common mental health issues.
In Atmiyata sw-CRT, we are testing effectiveness of the intervention at large scale and at community level
Roll out of an intervention is gradual which deprive last cluster of an effective intervention

12. Discussion

13. Who is gatekeeper?
Are we correct in choosing gatekeeper from each village? Who can be gatekeeper’s?
How to record gatekeeper permission- verbal or written?

14. Rule of randomization
Is it ethically correct to start an intervention with a cluster or cohort because it is administratively or politically feasible?

15. Dilemma about clinical equipoise
Is it an ethical to not to follow the principle of clinical equipoise?
Is delay in care consistent with clinical equipoise?