Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000410853
Ethics application status
Approved
Date submitted
12/02/2021
Date registered
15/04/2021
Date last updated
23/03/2022
Date data sharing statement initially provided
15/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Application of Text Messaging for Anxiety and Depression
Scientific title
Effect of a clinical text messaging intervention on symptoms in adults with anxiety and depression
Secondary ID [1] 303437 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 320741 0
Depression 320742 0
Condition category
Condition code
Mental Health 318579 318579 0 0
Anxiety
Mental Health 318580 318580 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clients of a psychology clinic with a diagnosis of anxiety or depression will receive daily text messages alongside weekly therapy for 8 weeks. Clients will receive one text message per day. Messages will not be personalised, as they are designed to be scalable, therefore everyone will receive identical texts. Text messages will be sent via an app (Nudge Learning) that is being developed specifically for this purpose. The app has the capacity to monitor the delivery of the messages and identify whether they have been opened.

Text messages will be based on Acceptance and Commitment Therapy and Self compassion and messages have been generated by researchers and clinicians in these fields. Some example messages include:
"Take a pause for a moment and name 5 things that you can see, 4 things that you can hear, 3 things that you can touch, 2 things that you can smell and 1 thing that you can taste. Becoming aware of the physical experience can help us to feel grounded and connected to the present moment."
"When you feel distressed, can you create a feeling of support and kindness for yourself?"
Intervention code [1] 319739 0
Treatment: Other
Intervention code [2] 320013 0
Behaviour
Comparator / control treatment
Control group will also be clients in a psychology clinic who are receiving therapy but do not receive the text messaging intervention.
Control group
Active

Outcomes
Primary outcome [1] 326538 0
Wellbeing which will be assessed using the STOP-D tool.
Timepoint [1] 326538 0
9x weekly timepoints - Pre-intervention and weekly for the 8 weeks of the intervention. T9, the last assessment at 8 weeks post intervention will be the primary timepoint.
Primary outcome [2] 326539 0
Value-consistent behaviour as assessed by the Universal Process Measure.
Timepoint [2] 326539 0
9x weekly timepoints - Pre-intervention and weekly for the 8 weeks of the intervention. T9, the last assessment at 8 weeks post intervention will be the primary timepoint.
Secondary outcome [1] 391803 0
Vitality will be assessed by the Subjective Vitality Scale
Timepoint [1] 391803 0
9x weekly timepoints - Pre-intervention and weekly for the 8 weeks of the intervention.
Secondary outcome [2] 391804 0
Perceived physical health will be assessed by the Universal Process Measure (self report of perceived physical health in the past week).
Timepoint [2] 391804 0
9x weekly timepoints - Pre-intervention and weekly for the 8 weeks of the intervention.

Eligibility
Key inclusion criteria
Diagnosis of anxiety or depression.
Adult 18+
Fluent in English
Current engaged with a psychologist
Own a smartphone
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cognitive impairment or current psychosis

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Multilevel modeling will also be utilised to analyse the data. Data will be nested at the client level which will allow analysis of the within-person relationships over time. We will examine the effect of therapy condition and time on client outcomes. We hypothesize an interaction between condition and time, which would suggest that the experimental condition had a stronger effect on the outcomes than the control condition. Multilevel modelling analysis can handle missing data and can analyse between and within person effects simultaneously.
Approximately 450 participants will be recruited based on a conservative power analysis where power is set at 0.9 and an effect size of 0.28. Effect size is estimated from studies of a similar design which ranged from .07 to .92, with pooled effect sizes for depression and mindfulness outcomes reported at .23 and .29, respectively (Linardon, 2020; Noordzij et al., 2010; Senanayake et al., 2019). This number also allows for attrition.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/04/2022
Actual
Date of last participant enrolment
Anticipated
18/12/2023
Actual
Date of last data collection
Anticipated
26/02/2024
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 33155 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 307857 0
Self funded/Unfunded
Name [1] 307857 0
None
Country [1] 307857 0
Primary sponsor type
University
Name
Australian Catholic University
Address
33 Berry St, North Sydney, NSW 2060
Country
Australia
Secondary sponsor category [1] 308569 0
None
Name [1] 308569 0
None
Address [1] 308569 0
None
Country [1] 308569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307861 0
ACU HREC
Ethics committee address [1] 307861 0
c/o Office of the Deputy Vice Chancellor (Research)
Australian Catholic University
North Sydney Campus
PO Box 968
NORTH SYDNEY, NSW 2059
Ethics committee country [1] 307861 0
Australia
Date submitted for ethics approval [1] 307861 0
04/09/2020
Approval date [1] 307861 0
18/11/2021
Ethics approval number [1] 307861 0
2020-168HC

Summary
Brief summary
This study aims to improve mental health outcomes for those with anxiety and depression by using an innovative text messaging intervention to supplement therapy. We hope to develop a scalable intervention via psychological flexibility-based text messages, which does not require personal contact, and can be delivered remotely. This study will involve a randomised controlled trial to determine the efficacy of the text messaging intervention. Clients of a psychology clinic will be allocated to a control (treatment as usual) or intervention group (treatment as usual plus text messaging intervention). Text messages will be based on Acceptance and Commitment Therapy and will be delivered daily for 8 weeks.

We hypothesise that the intervention group will have improved wellbeing compared to the control group after 8 weeks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 108734 0
Prof Joseph Ciarrochi
Address 108734 0
Australian Catholic University, Level 10, 33 Berry St, North Sydney 2060, NSW
Country 108734 0
Australia
Phone 108734 0
+61 2 9701 4662
Fax 108734 0
Email 108734 0
[email protected]
Contact person for public queries
Name 108735 0
Miss Courtney Baker
Address 108735 0
Australian Catholic University, 33 Berry St, North Sydney, NSW 2060
Country 108735 0
Australia
Phone 108735 0
+61 0466495631
Fax 108735 0
Email 108735 0
[email protected]
Contact person for scientific queries
Name 108736 0
Miss Courtney Baker
Address 108736 0
Australian Catholic University, 33 Berry St, North Sydney, NSW 2060
Country 108736 0
Australia
Phone 108736 0
+61 0466495631
Fax 108736 0
Email 108736 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10652Study protocol  [email protected]
10653Informed consent form    381419-(Uploaded-12-02-2021-12-18-21)-Study-related document.docx



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.