Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000488808
Ethics application status
Approved
Date submitted
16/09/2020
Date registered
27/04/2021
Date last updated
30/11/2023
Date data sharing statement initially provided
27/04/2021
Date results provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An app-based intervention for stress management among Chinese adolescents in school settings: A cluster randomized controlled trial
Scientific title
An app-based intervention for stress management among Chinese adolescents in school settings: A cluster randomized controlled trial investigating effect on perceived stress levels
Secondary ID [1] 301946 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perceived stress level 318496 0
Condition category
Condition code
Mental Health 316499 316499 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention will be a app-based program for stress management. This web-based program will be based on Stress Inoculation Training (SIT). SIT is a stress and anxiety management intervention developed by Mechanbaum. It comprises of relaxation training skills, cognitive reconstructing skills, problem-solving skills etc. This web-based intervention can be implemented via computer and mobile devices that have access to internet. The web-based program will be accessed via a URL link. The intervention will be administered by the first author: a PhD student with a background of school psychology and mental health (XZ). XZ is a registered counsellor in China, who has experience of doing group counselling and individual counselling with clients who have anxiety symptoms and depression symptoms. XZ also have experience with group and individual counselling with Chinese high school students. The intervention will be conducted in computer rooms, where participants can log in to the program via computers provided by the schools.

The intervention will comprise of 11 weekly sessions that will be completed in 3 months. Each session will take 30-35 minutes to complete. The web-based intervention will comprise of three phases: (i) conceptualization phase (session 1-3); (ii) skills acquisition and rehearsal phase (session 4-9); (iii) application and follow-through phase (session 10-11). Details of each session is described below:

The first session will focus on introduction and assessment. The following activities will be completed: (1) introduction about the web-based program and relevant ethical considerations; (2) implement of assessments (PSS-10; DASS-21; ORS-4; CISS-SFC); (3) psychoeducation about the transactional nature of stress.
In the second phase, the web-based program will work together with participants to analyse current problem (i.e., the nature of the participant's stress and coping strategies).
In the third session, the web-based program will work together with the participant to offer a conceptual model of the participant's stress reactions.

The fourth session will train relaxation skills with the participant by following four steps: (1) introduce stress-tension cycle; (2) tap the participant's previous experience with, concern with, and expectations concerning relaxation; (3) teach the participant relaxation skills through guided relaxation and deep breathing; (4) encourage the client to apply the relaxation skills into daily life.

In the fifth session, the chatbot will focus on coping strategies-cognitive restructuring by completing following activities: (1) help the client become aware of automatic thoughts; (2) introduce common "thought distortions"; (3) work with the client to recognize that their thoughts are not usually the facts, but the hypotheses worthy of testing; (4) encourage clients to do personal experiments about their thoughts.
In the sixth and seventh sessions, the web-based program will involve problem-solving training with the participant. Seven activities will be conducted in these two sessions: (1) problem-identification; (2) goal selection; (3) generation of alternatives; (4) change of position; (5) evaluation of pros and cons of each proposed solution; (6) strategy rehearsal; (7) encourage the participant to overcome failures and reward themselves for having tried.
In the eighth session, the web-based program will focus on self-instructional training. Two activities will be conducted, (1) review with the participant the various stages of their stress experience; (2) work with the participant to generate adaptive self-statements for their stages of stress experience.

In the ninth session, the program will focus on the role of "denial" on stress coping. Two activities will be conducted: (1) The chatbot will acknowledge that "denial" can be an adaptive strategy when there is no possibility to exert control; (2) encourage clients to focus on things important for them and that are consistent with their values.

The tenth session will focus on imagery rehearsal. Four activities will be conducted: (1) The chatbot and the participant collaboratively generate a hierarchy of scenes, from least to most stressful. The length lasts in 1-5 minutes; (2) The client is encouraged to use any personally generated self-statements and images that would facilitate coping. (3) If the client experience difficulty in reducing stress for any one scene, the participants will have options to either (i) go back to a less intensely stressful scene from the hierarchy or (ii) identify his/her “catastrophizing” self-statement when the participants become overwhelmed; (4) Throughout the imagery rehearsal procedure, the web-based program will always check with the participants about his/her reactions to the imagery process, discussing the users’ ability to visualize and when they can use coping techniques in vivo.

In the eleventh session, the web-based program will focus on behavioral rehearsal, role play and modelling. Two activities will be conducted: (1) The web-based program will role play with the client to practice coping skills (communication skills, mobilizing social support, and anger control); (2) The program will show the participant short videos of others coping with stressful events, and discuss with the users’ about other people’s coping efforts.

In the last session, the web-based program will focus on relapse prevention and follow-through. Six activities will be conducted: (1) The web-based program will encourage clients to anticipate failures and setbacks; (2) The program will work with the client to rehearse how they will respond to such lapses; (3) the web-based program will help the user to normalize setbacks, and educate the client that our aim is not to eliminate stress, but use the stress constructively; (4) The web-based program will convey to the users that the “door is always open”, and encourage the client to seek additional help if needed; (5) the web-based program will provide the users with additional help resources the client can seek when needed.
Intervention code [1] 318235 0
Behaviour
Comparator / control treatment
The control group in this trial will be wait list control, which means that the participants will not have access to the intervention program until the termination of the study (i.e., 16 weeks after the start of the intervention).
Control group
Active

Outcomes
Primary outcome [1] 324642 0
Change in scores on PSS-10 (perceived stress score-10 items)
Timepoint [1] 324642 0
Measures will be implemented at three timepoints: (1) pre-intervention (i.e., baseline); (2) right after completing the intervention (i.e., 12 weeks after starting the intervention, primary endpoint); (3) 4 weeks post-completion of intervention (i.e., follow-up assessment).
Secondary outcome [1] 385314 0
Depression and anxiety will be assessed by DASS-21, as a composite secondary outcome.
Timepoint [1] 385314 0
Measures will be implemented at three timepoints: (1) pre-intervention (i.e., baseline); (2) right after completing the intervention (i.e., 12 weeks after starting the intervention, primary endpoint); (3) 4 weeks post-completion of intervention (i.e., follow-up assessment).
Secondary outcome [2] 385315 0
Change in daily function will be assessed by Outcome Rating Scale (ORS-4). ORS-4 is a validate and reliable therapeutic instrument assessing key areas of life functioning in previous week.
Timepoint [2] 385315 0
Measures will be implemented at three timepoints: (1) pre-intervention (i.e., baseline); (2) right after completing the intervention (i.e., 12 weeks after starting the intervention, primary endpoint); (3) 4 weeks post-completion of intervention (i.e., follow-up assessment).
Secondary outcome [3] 385316 0
Stress coping behaviors will be measured using the short form of Coping Inventory for Stressful Situations (CISS-SFC). The CISS-SFC is a 21-item scale which measures three dimensions of coping-task-oriented coping, emotion-oriented coping, and avoidance-oriented coping.
Timepoint [3] 385316 0
Measures will be implemented at three timepoints: (1) pre-intervention (i.e., baseline); (2) right after completing the intervention (i.e., 12 weeks after starting the intervention, primary endpoint); (3) 4 weeks post-completion of intervention (i.e., follow-up assessment).

Eligibility
Key inclusion criteria
Chinese adolescents who (i) attend high schools, aged between 14-19; (ii) have access to mobile phones that are connected to the internet and were allowed by their parents to use mobile phones during intervention; and (iii) self-identified as feeling stressed.
Minimum age
14 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students who are suicidal; or/and have intellectual disabilities; or/and are diagnosed with mental illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The participants will be allocated randomly by clusters (e.g., classes). That would be more practical in school settings after communicating with two schools.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses will be performed using R*64 3.5.1. We will present descriptive data in a table: categorical variables (e.g., gender, grade, home location etc.) will be presented as counts and percentages. Continuous variables (e.g., age, PSS-10, DASS-21, ORS-4 etc.) will be presented as mean and standard deviation (SD).

To determine whether any significant differences exist between intervention group and control group at baseline, independent t test will be conducted on continuous baseline variables (e.g., age, PSS-10, DASS-21, ORS-4, CISS-SFC), and chi-square analyses will be conducted on categorical or nominal variables (e.g., gender, home location, guardian etc.).

To determine whether the intervention is effective, intention-to-treat (ITT) analyses will be conducted separately. The ITT analysis will include the data from the whole randomized sample. A repeated measure of linear mixed model (LMM) will be used to investigate the effects of time and groups on the primary outcome variables. The LMM will be performed with group, time, and group × time as fixed effects. Subjects and schools will be selected as random effects in order to take into consideration both within-subject and within-school correlations. Cohen d effect sizes will be calculated to examine the magnitude of between-group differences. Similar analyses will be conducted for exploring effects on secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2021
Actual
17/09/2021
Date of last participant enrolment
Anticipated
8/09/2021
Actual
8/10/2021
Date of last data collection
Anticipated
15/01/2022
Actual
14/02/2022
Sample size
Target
300
Accrual to date
Final
580
Recruitment outside Australia
Country [1] 22811 0
China
State/province [1] 22811 0
Sichuan Province

Funding & Sponsors
Funding source category [1] 306362 0
University
Name [1] 306362 0
The University of Queensland Research Training Scholarship
Country [1] 306362 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
280-284 Sir Fred Schonell Dr, St Lucia QLD 4067, Australia
Country
Australia
Secondary sponsor category [1] 306874 0
Other
Name [1] 306874 0
Centre for Online Health
Address [1] 306874 0
Building 33, Princess Alexandra Hospital 199 Ipswich Road Woolloongabba QLD 4102, Australia
Country [1] 306874 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306570 0
The University of Queensland, Human Research Ethics Office
Ethics committee address [1] 306570 0
Ethics committee country [1] 306570 0
Australia
Date submitted for ethics approval [1] 306570 0
10/04/2021
Approval date [1] 306570 0
14/09/2021
Ethics approval number [1] 306570 0
Ethics committee name [2] 306571 0
Tianjin Normal University, Research Ethics Committee
Ethics committee address [2] 306571 0
Ethics committee country [2] 306571 0
China
Date submitted for ethics approval [2] 306571 0
01/09/2020
Approval date [2] 306571 0
Ethics approval number [2] 306571 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104322 0
Ms Xiaoyun Zhou
Address 104322 0
Building 33, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102, Australia
Country 104322 0
Australia
Phone 104322 0
+61 04 13389757
Fax 104322 0
Email 104322 0
[email protected]
Contact person for public queries
Name 104323 0
Xiaoyun Zhou
Address 104323 0
Building 33, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102, Australia
Country 104323 0
Australia
Phone 104323 0
+61 0435776660
Fax 104323 0
Email 104323 0
[email protected]
Contact person for scientific queries
Name 104324 0
Xiaoyun Zhou
Address 104324 0
Building 33, Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102, Australia
Country 104324 0
Australia
Phone 104324 0
+61 0435776662
Fax 104324 0
Email 104324 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.