A protocol for a type 1 effectiveness-implementation randomized controlled trial of the WHO digital mental health intervention Step-by-Step to address depression among Chinese young adults in Macao (SAR), China

Hao Fong Sit; Gen Li; Wen Chen; Elvo Kuai Long Sou; Mek Wong; Sebastian Burchert; Ieng Wai Hong; Ho Yi Sit; Agnes Iok Fong Lam; Brian J Hall

doi:10.1016/j.invent.2022.100579

A protocol for a type 1 effectiveness-implementation randomized controlled trial of the WHO digital mental health intervention Step-by-Step to address depression among Chinese young adults in Macao (SAR), China

Internet Interv. 2022 Sep 28:30:100579. doi: 10.1016/j.invent.2022.100579. eCollection 2022 Dec.

Authors

Hao Fong Sit¹, Gen Li², Wen Chen^{3

4}, Elvo Kuai Long Sou⁵, Mek Wong⁵, Sebastian Burchert⁶, Ieng Wai Hong⁷, Ho Yi Sit⁸, Agnes Iok Fong Lam⁹, Brian J Hall²

Affiliations

¹ Department of Psychology, The University of Hong Kong, Pokfulam, Hong Kong (SAR), People's Republic of China.
² Center for Global Health Equity, New York University (Shanghai), Shanghai, People's Republic of China.
³ Department of Medical Statistics, School of Public Health, Sun Yat-sen University, Zhongshan Road 2, Guangzhou, People's Republic of China.
⁴ Sun Yat-sen Centre for Migrant Health Policy, Sun Yat-sen University, Zhongshan Road 2, Guangzhou, People's Republic of China.
⁵ Student Affairs Office, University of Macau, Macao (SAR), People's Republic of China.
⁶ Department of Education and Psychology, Division of Clinical Psychological Intervention, Freie Universität Berlin (FUB), Germany.
⁷ Moon Chun Memorial College, University of Macau, Macao (SAR), People's Republic of China.
⁸ Shiu Pong College, University of Macau, Macao (SAR), People's Republic of China.
⁹ Centre for Macau Studies, University of Macau, Macao (SAR), People's Republic of China.

Abstract

Background: Among Chinese college students, the burden of depression is considerably high, affecting up to 30 % of the population. Despite this burden, few Chinese students seek mental health treatment. In addition, depression is highly comorbid with other mental health disorders, such as anxiety. Scalable, transdiagnostic, evidence-based interventions are needed for this population.

Objective: The study will evaluate the effectiveness of a World Health Organization transdiagnostic digital mental health intervention, Step-by-Step, to reduce depressive and anxiety symptoms and improve well-being compared with enhanced care as usual and its implementation in a Chinese university community.

Methods: A type 1 effectiveness-implementation two-arm, parallel, randomized controlled trial will be conducted. The two conditions are 1) the 5-session Step-by-Step program with minimal guidance by trained peer-helpers and 2) psychoeducational information on depression and anxiety and referrals to local community services. A total of 334 Chinese university students will be randomized with a 1:1 ratio to either of the two groups. Depression, anxiety, wellbeing, and client defined problems will be assessed at pre-intervention, post-intervention, and 3-month follow-up. Endline qualitative interviews and focus group discussions will be conducted to explore SbS implementation among service users, university staff, and stakeholders. Data will be analysed based on the intent-to-treat principle.

Discussion: Step-by-Step is an innovative approach to address common mental health problems in populations with sufficient digital literacy. It is a promising intervention that can be embedded to scale mental health services within a university setting. It is anticipated that after successful evaluation of the program and its implementation in the type 1 hybrid design RCT study, Step-by-Step can be scaled and maintained as a low-intensity treatment in universities, and potentially extended to other populations within the Chinese community.

Trial registration: ChiCTR2100050214.

Keywords: AE, adverse event; Behavioral activation; CONSORT, Consolidated Standards of Reporting Trials; CSQ, Client Satisfaction Questionnaire; College students; DASS-21, Depression, Anxiety, and Stress Scale – 21 items; Depression; Digital intervention; ECAU, enhanced care as usual; GAD-7, Generalized Anxiety Disorder; ITT, intention-to-treat; Implementation; PCC, Psychological Counselling Center; PCL, PTSD Checklist for DSM-5; PHQ, Patient Health Questionnaire; PSYCHLOPS, Psychological Outcomes Profile Instrument; RCT, randomized controlled trial; RE-AIM, Reach, Effectiveness, Adoption, Implementation, and Maintenance; Randomized controlled trial; SAE, serious adverse event; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; SbS, Step-by-Step; WHO, World Health Organization.