Clinical trial NCT06013488: Character-Strengths Based Coaching For Work-Stress Reduction For Health Workers
Official title: A Character-Strengths Based Coaching Program for Rural Community Health Workers to Address Their Work Stress in India: Protocol for a Two-arm Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Work Related Stress
Burnout, Psychological
Mental Health Issue
Keywords: character strengths
community health workers
work stress
India
randomized controlled trial
positive psychology
Lead sponsor: Templeton World Charity Foundation
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employs a 2-arm parallel randomized controlled trial design. Participants will be randomly allocated to 1) a character-strengths based coaching intervention consisting of a five-day residential workshop and supplemental 8- to 10-week remote telephonic coaching support in addition to 'routine (health system) supervision' (face-to-face by a supervisor in groups of 1 supervisor for \~20 health workers), or 2) 'routine supervision' alone.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this two-arm, parallel group individual randomized controlled trial is to evaluate the effectiveness of a character-strengths based coaching intervention consisting of a five-day residential workshop focusing on the use of character-strengths to address work-stress in routine situations supplemented by 8- to 10-week remote telephonic weekly coaching sessions to support rural health workers, as they face stressful situations and apply the strategies learnt in the workshop. The arms are: the character-strengths based intervention added to routine health worker supervision (weekly, by the supervisor) and routine supervision alone (control arm). The target sample comprises 330 government contracted 'ASHAs' (rural resident women, lay health workers) in the Sehore district of Madhya Pradesh, one of the most populous and poorest of the states in India. Scores on the 'Authentic Happiness Inventory (AHI)' will serve as the primary outcome for self-reported wellbeing and will be compared between arms at 3-month follow-up. Secondary ASHA-level outcomes will include assessment of self-reported affect, self-efficacy, flourishing, burnout, and motivation. We will also collect exploratory outcomes, including routine service delivery indicators to assess any effect of changes in well-being on ASHA's regular work performance, and resulting patient-level outcomes like satisfaction with services, and depression severity levels after receiving community-based depression care delivered by the ASHAs. We will also evaluate the costs of delivering the intervention and those incurred by ASHAs due to their participation in the intervention. Assessors blind to participant allocation will collect outcomes at baseline, 1-month and 3-month follow-up, as well as at 6-month follow-up, to ascertain differences in outcomes between arms. In addition, scores of ASHAs' self-perceived character strengths will be collected at baseline and 3-month follow-up as exploratory variables.

Detailed description: Character strengths-based interventions are found to be effective in improving well-being and reducing burnout amongst healthcare workers. But there is scarce knowledge on the use of structured positive psychology interventions for reduced work-stress and improving mental wellbeing of Accredited Social Health Activists (ASHAs). ASHAs are village level community lay health care workers who provide the bulk of the health care services in rural India. ASHAs are overworked and underpaid and subjected to considerable stress for both professional and domestic reasons (being married, rural, traditional women). This study will test the effectiveness of a 'character-strengths' based coaching intervention on ASHAs' self-reported wellbeing.

This study will evaluate the effectiveness of the aforementioned coaching intervention compared with routine supervision (delivered by one ASHA supervisor, weekly, face-to-face, typically in groups of \~20 ASHAs) on self-reported wellbeing score at 3-month follow-up. In this trial, a total of 330 ASHAs will be recruited in Sehore District of Madhya Pradesh, a large and predominantly rural state situated in central India.

The development of the coaching intervention (published elsewhere, Khan A et al., 2023) involved: (1) formative work, (2) blueprint development, (3) content development, (4) content-testing, and focus groups discussions to evaluate the feasibility and acceptability of the intervention, specifically the coaching workshop. This was followed by thematic qualitative analysis of ASHA perspectives/feedback to inform further modifications to the workshop. Intervention development occurred over 11 months, and the final coaching material consisted of a 'content manual' (for ASHAs) with four modules including character-strengths based 'strategies' to address challenges/stressors arising at health facilities, village communities and homes. Coaching material also included a workshop 'facilitator's manual' having session-wise detailed instructions, a list of 'energizers' and plans for the coaching workshop; and a protocol for remote telephonic coaching support to provide follow-on weekly support to ASHAs (typically 30-45 minute phone-calls) as they resume work (and experience stressors) and reinforce the learnings of the workshop.

This trial will determine whether character-strengths based coaching is an effective and scalable approach for reducing work-stress and improving mental wellbeing of rural ASHAs in low-resource settings. The findings from this trial will inform broader efforts to develop similar stress-reduction interventions, which are necessary for related cadres (e.g., nurse midwives, rural doctors) in low-resource settings in India and other low- and middle-income countries.

Eligibility criteria: Inclusion Criteria:

* All rural ASHAs residing and working in Sehore district, Madhya Pradesh (verified in the health system records) and who have been trained by the study team on delivering community-based depression care

Exclusion Criteria:

* ASHAs who plan to migrate within six months of recruitment
* ASHAs who do not plan to continue working, or those who have resigned or planning to change jobs within six months of recruitment
* ASHAs with urban catchment areas
* ASHA supervisors will not be included owing to hierarchical differences in these two cadres and their potential effects on absorption of intervention content, and thereby on their wellbeing (primary outcome of interest)
* ASHAs who have difficulties in using a smartphone

Primary outcomes:
measure: Mean score on the Authentic Happiness Inventory (AHI)
timeFrame: Baseline, 3-month and 6-month follow-up
Secondary outcomes:
measure: Mean score on the Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline, 1-month and 3-month follow-up
measure: Mean score on Flourish Index (FI) and Secure Flourish Index (SFI)
timeFrame: Baseline, 1-month and 3-month follow-up
measure: Mean score on Occupational Self-Efficacy Scale (OSES)
timeFrame: Baseline, 1-month and 3-month follow-up
measure: Mean score on the Emotional exhaustion sub-scale of the Maslach Burnout Inventory-Human Service Survey (MBI-HSS)
timeFrame: Baseline, 3-month and 6-month follow-up
measure: Mean score on the motivation scale for Indian frontline workers
timeFrame: Baseline, 3-month and 6-month follow-up
Other outcomes:
measure: Service delivery indicators
timeFrame: Baseline, 1-month, 3-month and 6-month follow-up
measure: Healthy Activity Program (HAP) session quality
timeFrame: 3-month and 6-month follow-up
measure: Patient satisfaction with HAP
timeFrame: 3-month follow-up of the patient receiving HAP by ASHA
measure: Remission on nine-item Patient Health Questionnaire (PHQ-9)
timeFrame: 3-month follow-up of the patient receiving HAP by ASHA
measure: Cost assessment of the character-strengths based coaching intervention
timeFrame: Day-5 of residential workshop and 2nd, 4th, 6th and 8th coaching support call (only for intervention arm ASHAs)
measure: Self-perceived strengths assessment
timeFrame: Baseline and 3-month follow-up
Locations:
city: Bhopal
country: India
facility: Sangath Bhopal Hub
state: Madhya Pradesh
Study officials:
affiliation: Site Head, Sangath Bhopal Hub
name: Anant Bhan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khan, A., Sharma, L., Agrawal, S. et al. Development of a character-strengths based coaching program for rural community health workers to address their work stress in Madhya Pradesh, India. Curr Psychol (2023). https://doi.org/10.1007/s12144-023-04673-3