NCT06013488

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

August 22, 2023

Last Update Submit

November 18, 2024

Conditions

Keywords

character strengthscommunity health workerswork stressIndiarandomized controlled trialpositive psychology

Outcome Measures

Primary Outcomes (1)

  • Mean score on the Authentic Happiness Inventory (AHI)

    Authentic Happiness Inventory (AHI) is a subjective measure for the assessment of happiness. We have used the term 'wellbeing' in the protocol to represent this specific measure of happiness. AHI includes 24 sets of five statements \[e.g., ranging from 1 ("I feel like a failure") to 5 ("I feel I am extraordinarily successful")\] from which, the respondent chooses the statement that best describes her feelings in the past one week. AHI has been designed for monitoring upward changes in happiness and has often been used in positive psychology intervention studies. Internal consistency at pre-test has been reported to be high (Cronbach's α = 0.94). AHI will be administered at baseline, and at 3 and 6 months thereafter. The primary outcome analysis will involve a comparison of mean AHI scores between arms at 3-month follow-up.

    Baseline, 3-month and 6-month follow-up

Secondary Outcomes (5)

  • Mean score on the Positive and Negative Affect Schedule (PANAS)

    Baseline, 1-month and 3-month follow-up

  • Mean score on Flourish Index (FI) and Secure Flourish Index (SFI)

    Baseline, 1-month and 3-month follow-up

  • Mean score on Occupational Self-Efficacy Scale (OSES)

    Baseline, 1-month and 3-month follow-up

  • Mean score on the Emotional exhaustion sub-scale of the Maslach Burnout Inventory-Human Service Survey (MBI-HSS)

    Baseline, 3-month and 6-month follow-up

  • Mean score on the motivation scale for Indian frontline workers

    Baseline, 3-month and 6-month follow-up

Other Outcomes (6)

  • Service delivery indicators

    Baseline, 1-month, 3-month and 6-month follow-up

  • Healthy Activity Program (HAP) session quality

    3-month and 6-month follow-up

  • Patient satisfaction with HAP

    3-month follow-up of the patient receiving HAP by ASHA

  • +3 more other outcomes

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants (health workers) allocated to this arm continue to receive the traditional weekly supervision delivered by their supervisor, assigned by the health system, in a face-to-face mode in groups of 1:20 (1 supervisor for a group of \~20 health workers). In addition, participants receive a 5-day residential coaching workshop involving character-strengths based strategies to reduce work-stress, followed by supplemental 8- to 10-week remote telephonic coaching support, after the workshop when they resume work (and experience stressors). The weekly coaching support calls typically last for 30-45 minutes and are delivered by an assigned intervention coach (by the study team) to the health worker (1:1).

Behavioral: Character Strengths Based Coaching SupportBehavioral: Routine Supervision

Control Arm

ACTIVE COMPARATOR

Participants (health workers) allocated to this arm receive the traditional weekly supervision delivered by their supervisor, assigned by the health system, in a face-to-face mode in groups of 1:20 (1 supervisor for a group of \~20 health workers).

Behavioral: Routine Supervision

Interventions

Residential (five day) workshop and remote (weekly) telephonic support for 8 to 10 weeks

Intervention Arm

Weekly face-to-face supervision by supervisor in groups of \~20 (1 supervisor for \~20 health workers)

Control ArmIntervention Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sangath Bhopal Hub

Bhopal, Madhya Pradesh, 462042, India

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Occupational StressBurnout, Psychological

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Anant Bhan

    Site Head, Sangath Bhopal Hub

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
In this trial, the Outcome Assessors administering study assessments at baseline and at 1-, 3- and 6-month follow-up will be masked to the intervention arm that participants are allocated to receive. Masking outcome assessors will minimize potential bias due to knowledge of which arm the participant is allocated to, and can ensure unbiased ascertainment of study outcomes. For allocation concealment, the intervention allocation for each participant will not be revealed to the participant until they have been enrolled into the trial, to avoid selection bias.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

August 21, 2023

Primary Completion

July 30, 2025

Study Completion

September 30, 2025

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations