Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000996460
Ethics application status
Approved
Date submitted
26/07/2016
Date registered
28/07/2016
Date last updated
25/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Stress-Less Mobile App: An app-intervention to reduce stress in adult carers
Scientific title
An evaluation of a smartphone-based program to reduce stress in adult carers
Secondary ID [1] 289764 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 299628 0
Subjective Wellbeing 299629 0
Condition category
Condition code
Mental Health 299586 299586 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a smartphone app-based intervention called the 'Stress-Less Mobile App' to reduce stress and improve personal wellbeing. This group is prompted (via app) to monitor responses to stress up to 4 times per day (randomly twice in the a.m. and twice in the p.m.) for a period of 5 weeks. Participants set (via the app) earliest and latest times to receive the first and last prompt of each day. At each prompt, participants respond to a one-minute survey that will evaluate participants' experiences of stressful events (i.e., Have you experienced a stressful event in the last 30 mins?), types of strategies employed to cope with stress (i.e., I talked to someone about it), their perceptions about how they coped with the stressor (i.e., At the time, how confident did you feel dealing with the stressful situation), and stress levels (i.e., How stressed do you feel right now?). They will receive tailored feedback (via graphical displays in the app) about how they respond to stress, and thus will be able self monitor progress throughout the days and weeks. In addition this group is given access to intervention materials (via app), with the instructions to complete each of the 5 x 30 minute modules in sequence. It is emphasised that the modules are designed to be paced at one per week. The treatment material consists of 5 modules based on 3rd Wave Cognitive and Behavioural approaches to treat stress and negative moods, and to improve resilience and subjective wellbeing: (1) acceptance and commitment therapy (ACT) to identify personal values (2) mindfulness based stress reduction to diffuse stress, tension, and negative thoughts and feelings (3) wellbeing maintenance to promote healthy levels of self-esteem, optimism, and to savour acts of gratitude and kindness, (4) Behavioural Activation to increase social support seeking, exposure to positive situations, and act in accordance with values (5) Troubleshooting for relapse prevention. In addition to self-guided use of intervention materials, (i.e., complete one module per week for 5 weeks), this group will also be invited to undertake brief, additional content (top-up activities) at times of greatest need (i.e., when their stress scores are elevated they may be recommended to complete a brief relaxation task). These top-up activities are additional to, rather than substitutes for, the 5 weeks of module content, and participants are encouraged to continue to progress through the 5 modules regardless of how many times they may engage in to-up activities. Adherence and usage is monitored by the app for both intervention and control groups. The treatment group will receive weekly check-ins from the research team (via text and phone and email) to promote cohort engagement
Intervention code [1] 295414 0
Treatment: Other
Intervention code [2] 295432 0
Treatment: Devices
Comparator / control treatment
Control condition:
This group downloads an app that monitors responses to stress throughout the duration (5 weeks) of the intervention phase, but does not link to intervention content. This is a more suitable control condition than simply taking baseline and post-intervention measures of stress because the act of filling out ratings of stress responsiveness throughout the intervention phase may, in itself, be a low-level form of intervention, by enhancing awareness of stress symptoms. To mirror the number of assessments given to the intervention conditions, this control group will complete assessments of stress responsiveness via the app up to 4 times per day for the duration of the intervention phase (5 weeks).
Control group
Active

Outcomes
Primary outcome [1] 299060 0
Stress severity as measured by the stress subscale of the depression, anxiety, and stress scale (DASS-21)
Timepoint [1] 299060 0
DASS-21 Stress subscale scores will be obtained at baseline, 6 weeks (post-intervention point), and 3 months follow-up (3 months after post-intervention point).
Primary outcome [2] 299061 0
Subjective Wellbeing as assessed by the Personal Wellbeing Index
Timepoint [2] 299061 0
Personal Wellbeing scores will be obtained at baseline, 6 weeks (post-intervention point), and 3 month follow-up (3 months after post-intervention point).
Secondary outcome [1] 326048 0
Retention rates as assessed by those who provide DASS-21 data and Personal Wellbeing data at all time points (T1-T3) versus those who do not.
Timepoint [1] 326048 0
At 6-weeks post-intervention and 3 month follow-up.

Eligibility
Key inclusion criteria
(1) Aged 18 years and over
(2) Helping to support a friend or relative with a physical or mental condition/disability
(3) Access to a smartphone for the duration of testing to access and use our app
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) Not fluent in English
(2) Younger than 18 years
(3) Doesn't have access to a smartphone with internet access for duration of the study
(4) Participated in eHealth intervention within the previous 6 months.

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)
After completing the online consent process, participants click through to the online baseline survey. This online survey randomly allocates them to the control or intervention arms of the study. As such, the randomization process is unbiased by researchers selecting participants to one or other of the conditions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization created by online survey powered by Qualtrics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2016
Actual
22/09/2016
Date of last participant enrolment
Anticipated
28/04/2017
Actual
15/04/2017
Date of last data collection
Anticipated
2/06/2017
Actual
29/11/2017
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 294145 0
Commercial sector/Industry
Name [1] 294145 0
Australian Unity Health Insurance Agency
Country [1] 294145 0
Australia
Primary sponsor type
University
Name
Centre for Social and Early Emotional Development, School of Psychology, Faculty of Health, Deakin University
Address
Deakin University
221 Burwood Highway
Burwood
VIC 3125
Country
Australia
Secondary sponsor category [1] 292975 0
None
Name [1] 292975 0
Address [1] 292975 0
Country [1] 292975 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295556 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 295556 0
Ethics committee country [1] 295556 0
Australia
Date submitted for ethics approval [1] 295556 0
02/05/2016
Approval date [1] 295556 0
07/07/2016
Ethics approval number [1] 295556 0
2016-151

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

Contacts
Principal investigator
Name 67738 0
A/Prof Matthew Fuller-Tyszkiewcz
Address 67738 0
Level 5, BC Building
School of Psychology
Deakin University
221 Burwood Highway, Burwood
VIC 3125
Country 67738 0
Australia
Phone 67738 0
+61 3 9251 7344
Fax 67738 0
+61 3 9244 6858
Email 67738 0
[email protected]
Contact person for public queries
Name 67739 0
Ben Richardson
Address 67739 0
The Cairnmillar Institute: Camberwell Campus, 993 Burke Road Camberwell VIC 3124
Country 67739 0
Australia
Phone 67739 0
+61 3 9813 3400
Fax 67739 0
+61 3 9882 9764
Email 67739 0
[email protected]
Contact person for scientific queries
Name 67740 0
Matthew Fuller-Tyszkiewicz
Address 67740 0
BC 4.112, BC Building
School of Psychology
Deakin University
221 Burwood Highway, Burwood
VIC 3125
Country 67740 0
Australia
Phone 67740 0
+61 3 9251 7344
Fax 67740 0
+61 3 9244 6858
Email 67740 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of a smartphone app intervention for reducing caregiver stress: Randomized controlled trial.2020https://dx.doi.org/10.2196/17541
N.B. These documents automatically identified may not have been verified by the study sponsor.