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Trial registered on ANZCTR


Registration number
ACTRN12616000248460
Ethics application status
Approved
Date submitted
18/02/2016
Date registered
23/02/2016
Date last updated
15/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An Evaluation of Mobile-Based Worry Postponement Application in the Management of Worry and Anxiety Symptoms
Scientific title
An Evaluation of Mobile-Based Worry Postponement Application in the Management of Worry and Anxiety Symptoms
Secondary ID [1] 288510 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Anxiety Disorder 297579 0
Anxiety 297580 0
Condition category
Condition code
Mental Health 297776 297776 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will involve the use of a newly designed smartphone application ("app") available for download on the Apple and Google Play stores. The experimental app assists users in the process of worry postponement, which allows them to record their worries and postpone them to a time of their choosing, giving them greater control over their worries and anxiety. Participants will be encouraged to use the app at least once daily across a 4-week intervention period, but they are free to use the apps as frequently or infrequently as they wish. Participants will continue to have access to the app during the follow-up period (1- and 3-months after the active intervention period). Page views will be monitored by the app software.
Intervention code [1] 293871 0
Treatment: Devices
Comparator / control treatment
The control treatment will involve a control app that allows users to record and review their worries throughout the day, allowing them to keep track of their worries. The app also allows users to add action plans to worries, detailing how they will deal with particular worries by adding notes alongside them. Participants will be encouraged to use the app at least once daily across a 4-week intervention period, but they are free to use the apps as frequently or infrequently as they wish. Participants will continue to have access to the app during the follow-up period (1- and 3-months after the active intervention period). Page views will be monitored by the app software.
Control group
Active

Outcomes
Primary outcome [1] 297302 0
Self-reported worry as measured by the Penn-State Worry Questionnaire (PSWQ).
Timepoint [1] 297302 0
Baseline (Prior to assignment of app condition), Post-Intervention (immediately following completion of 4-week intervention period) and 1-Month Follow-Up (1-month after the post-intervention testing period)
Primary outcome [2] 297303 0
Negative metacognitive beliefs about the danger and uncontrollability of worry as measured by the Metacognitions Questionnaire (MCQ) - Uncontrollability and Danger Subscale (MCQ-UD)
Timepoint [2] 297303 0
Baseline (Immediately following the first week of intervention), Weeks 2 and 3 (immediately following the second and third weeks of the intervention), Post-Intervention (immediately following the fourth/final week of intervention), 1-Month Follow-Up (After a 1-month interval following the post-intervention testing)
Primary outcome [3] 297304 0
Self-reported anxiety/worry symptom severity as measured by the Generalised Anxiety Disorder-7 (GAD-7) Questionnaire.
Timepoint [3] 297304 0
Baseline (immediately following the first week of intervention), Weeks 2 and 3 (immediately following the second and third weeks of intervention), Post-Intervention (immediately following the fourth/final week of intervention), 1-Month Follow-Up (After a 1-month interval following the post-intervention testing).
Secondary outcome [1] 320669 0
Repetitive negative thinking as measured by the Repetitive Thinking Questionnaire-10 (RTQ-10)
Timepoint [1] 320669 0
Baseline (Prior to assignment of app condition), Post-Intervention (immediately following the fourth/final week of intervention), 1-Month Follow-Up (After a 1-month interval following the post-intervention testing)

Eligibility
Key inclusion criteria
Inclusion criteria includes: 1) Participants who score 45 or above on the Penn-State Worry Questionnaire (PSWQ), 2) Access to smartphone with access to the iOS or Google Play stores.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes 1) Participants who endorse moderate to high suicide risk on the Mini International Neuropsychiatric Interview (MINI), 2) Participants currently engaged in concurrent psychological treatment for depression or anxiety, 3) Participants who expect any changes to their medication dosage and routine in the following month, 4) Participants without access to a smartphone with access to the iOS or Google Play stores.

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)
To ensure allocation concealment during the initial screening and assessment, participants will first be screened by an assessor blind to the participant's condition. Once eligibility has been confirmed, the assessor will contact the project administrator who will inform the assessor of the participant's treatment allocation (experimental or control app). The assessor will then provide the participant with the details required to download their allocated app and commence the study. Blind assessors will then conduct the post-treatment and follow-up diagnostic interviews and will then be asked to guess each participant's allocation. If the guess at around chance, we can be confident that blinding was successful.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised sequence generation will be used to allocate participants to treatment condition.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To determine whether the use of the experimental app is associated with a significant reduction in negative metacognitive beliefs (uncontrollability and danger), worry, repetitive negative thinking (RNT) and symptoms of GAD, a generalised linear mixed model will be used. There will be one nominal fixed effect (group: experimental, control), four ordinal fixed effects (Time: pre-test, week 1, week 2, week 3, post-test, 1-month follow-up, 3-month follow-up for MCQ-UD and GAD-7; Time: pre-test, post-test, 1-month follow-up, 3-month follow-up for all other measures), and the Group x Time interaction. Significant Group x Time interactions will be analysed by conducting Least Significant Difference (LSD) contrasts across the simple main effects of Time. An a priori power analysis was conducted using G*Power (version 3.1.9.2, Buchner, Erdfelder, Faul, & Lang, 1992-2014) to determine the required sample size to achieve 80% power to detect a medium interaction effect size (f = .25) at an alpha level of .05. This analysis revealed that 14 participants per group are required (total N = 28).
To determine whether there is an indirect effect of App Condition (Experimental, Control) on GAD symptoms, worry, and RNT via changes in negative metacognitive beliefs, PROCESS macro for SPSS will be used (Hayes, 2013). App Condition (Experimental, Control) will be input as the independent variable with GAD-7 total scores, PSWQ total scores, and RTQ-10 total scores being input as the dependent variables and the MCQ-UD subscale scores being input as the mediator. A power analysis for the mediation analyses suggested that a total sample of 68 is required for an 80% chance of detecting a medium effect (f = .25) at an alpha level of .05, so a minimum of 68 participants (34 per group) will be recruited for the study. We will seek to recruit 10% more than the required number of participants to account for any attrition between recruitment and dropout prior to commencing with the study (Total N = 76, 38/group). Once randomised all participants will be included in the analyses.
All analyses will be intention to treat. GLMM is less sensitive to participant attrition than ANOVA because it does not rely on participants providing data at every assessment point; the GLMM maximum likelihood procedure is a full information estimation procedure that uses all data present at each assessment point. This reduces sampling bias and the need to replace missing data. GLMM is able to use the data present at each assessment point because (pre-test, week 1, week 2, week 3, post-test, 1- and 3-month follow-up) is interpreted as a Level 1 variable that is nested within participant at Level 2.
Descriptive data regarding the frequency and type of self-reported use will be reported. Pearson correlations between frequency, type of self-reported use and outcome measures (worry, anxiety symptoms, repetitive negative thinking and negative metacognitive beliefs about uncontrollability and danger) will be conducted, to determine whether usage is related to treatment outcome.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
25/02/2016
Actual
21/03/2016
Date of last participant enrolment
Anticipated
Actual
11/11/2016
Date of last data collection
Anticipated
15/01/2017
Actual
Sample size
Target
76
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292859 0
University
Name [1] 292859 0
Curtin University
Country [1] 292859 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 291605 0
None
Name [1] 291605 0
Address [1] 291605 0
Country [1] 291605 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294358 0
Human Research Ethics Committee - Curtin University
Ethics committee address [1] 294358 0
Kent Street, Bentley WA 6102
Ethics committee country [1] 294358 0
Australia
Date submitted for ethics approval [1] 294358 0
Approval date [1] 294358 0
14/01/2016
Ethics approval number [1] 294358 0
HR225/2015/AR1

Summary
Brief summary
Approximately 68% of adults worldwide own mobile phones, with an estimated 1.08 billion of these being smartphones. Studies have shown that more people own a smartphone than a computer. Mobile health allows for the provision of evidence-based therapeutic techniques to a greater proportion of the population. Anxiety disorders are the most common mental disorders and the current study aims to evaluate the efficacy of a smartphone application ("app") designed to reduce worry by giving users greater control over it. Participants will be randomly assigned to use one of two apps. Measures of worry, depression, anxiety, negative metacognitive beliefs and repetitive negative thinking will be taken pre-, post- and follow-up intervals, with weekly measures of anxiety and negative metacognitive beliefs during the intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63418 0
A/Prof Peter McEvoy
Address 63418 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, WA, 6102
Country 63418 0
Australia
Phone 63418 0
+618 9266 5110
Fax 63418 0
Email 63418 0
[email protected]
Contact person for public queries
Name 63419 0
A/Prof Peter McEvoy
Address 63419 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, WA, 6102
Country 63419 0
Australia
Phone 63419 0
+618 9266 5110
Fax 63419 0
Email 63419 0
[email protected]
Contact person for scientific queries
Name 63420 0
A/Prof Peter McEvoy
Address 63420 0
School of Psychology and Speech Pathology
Curtin University
Kent Street, Bentley, WA, 6102
Country 63420 0
Australia
Phone 63420 0
+618 9266 5110
Fax 63420 0
Email 63420 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

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