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
; 30: 100579, 2022 Dec.
Article
en En
| MEDLINE
| ID: mdl-36217366
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.
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
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Tipo de estudio:
Clinical_trials
/
Guideline
/
Qualitative_research
Idioma:
En
Revista:
Internet Interv
Año:
2022
Tipo del documento:
Article
Pais de publicación:
Países Bajos