Character-Strengths Based Coaching For Work-Stress Reduction For Health Workers

NCT ID: NCT06013488

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-21

Study Completion Date

2025-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Work Related Stress Burnout, Psychological Mental Health Issue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Arm

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).

Group Type EXPERIMENTAL

Character Strengths Based Coaching Support

Intervention Type BEHAVIORAL

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

Routine Supervision

Intervention Type BEHAVIORAL

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

Control Arm

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).

Group Type ACTIVE_COMPARATOR

Routine Supervision

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Character Strengths Based Coaching Support

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

Intervention Type BEHAVIORAL

Routine Supervision

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Templeton World Charity Foundation

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anant Bhan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anant Bhan

Role: PRINCIPAL_INVESTIGATOR

Site Head, Sangath Bhopal Hub

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sangath Bhopal Hub

Bhopal, Madhya Pradesh, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ameya Bondre

Role: CONTACT

00918874041444

Deepak Tugnawat

Role: CONTACT

00918523843957

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Anant Bhan

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TWCF0635

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.