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A type II hybrid implementation-effectiveness study of the BECOME intervention: integrating Behavioral Community-Based Approaches for Mental Health and Non-Communicable Diseases delivered by community health workers—study protocol for a stepped wedge cluster randomized controlled trial

Crossref DOI link: https://doi.org/10.1186/s13063-026-09457-1

Published Online: 2026-01-24

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Sigdel, Kripa

Nepal, Jyoti https://orcid.org/0000-0001-9911-6019
Shrestha, Archana

Rai, Bala

Yogi, Bhawani

Schillinger, Dean

Sharma, Dikshya

Prajapati, Dipanker

Heylen, Elsa

Niraula, Hira Kumari

Shrestha, Jene

Dhimal, Meghnath

Sah, Navin Kumar

Baral, Phanindra Prasad

Limbu, Pinki

Nepal, Prajwol

Paudel, Puskar

Nepali, Sajama

Poudel, Sanjay

Joshi, Saugat

Tiwari, Shristi

Shrestha, Srijana

Sapkota, Sabitri

Acharya, Bibhav
Funding

Funding for this research was provided by:

National Institute of Mental Health (R01MH133231)
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Text and Data Mining valid from 2026-01-24

Version of Record valid from 2026-02-17
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Article History

Received: 7 July 2025

Accepted: 12 January 2026

First Online: 24 January 2026

Declarations

:

: The ethical approval for the study is obtained from institutional review boards of both University of California, San Francisco (IRB #22–38288) on 04/06/2023 and Nepal Health Research Council (registration #256/2023) on 07/13/2023. The trained ROAs obtain written informed consent from all participants prior to enrollment, and verbal consent before follow-up assessments, including IDIs. Any amendments to the trial protocol are communicated to the relevant ethical/institutional review boards, participants, and members of the data safety and monitoring board.

: Not applicable. We will provide the model consent form upon request.

: The authors declare that they have no competing interests.

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