Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001701819
Ethics application status
Approved
Date submitted
9/11/2021
Date registered
13/12/2021
Date last updated
16/03/2022
Date data sharing statement initially provided
13/12/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot trial of Mello: Investigating the effect of a targeted, personalised smartphone app on repetitive negative thinking in young people with depression and anxiety
Scientific title
Pilot randomised controlled trial of a real time, personalised, transdiagnostic smartphone intervention targeting repetitive negative thinking in young people with depression and anxiety
Secondary ID [1] 304579 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Depression 322470 0
Anxiety 322471 0
Condition category
Condition code
Mental Health 320110 320110 0 0
Anxiety
Mental Health 320111 320111 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arm will be given access to a smartphone app called Mello for a total of 6 weeks, which will be downloaded onto their own iPhone or Android device. They will be free to use Mello as much or as little as they want during this time. Mello is a world first smartphone intervention targeting repetitive negative thinking (RNT); a key transdiagnostic process underpinning depression and anxiety. RNT involves repeatedly going over negative thoughts in the mind in a way that is passive and/or difficult to control, resulting in reinforcement of negative mood states. As RNT is a mechanism which has been found to drive depression and anxiety, interventions that effectively reduce RNT may have a flow on effect for improving depression and anxiety outcomes.

Mello offers a means of disrupting RNT as it unfolds in the moment by delivering personalised interventions at key moments in daily life via a smartphone app. Delivering momentary interventions in daily life is referred to as ecological momentary intervention (EMI). Via an interactive chat interface, users are prompted three times a day to complete a short four item questionnaire (‘check in’) via the app to gather contextual information about current levels of RNT, mood, surrounding environment and activities. Each item is rated on a 5 point Likert-type scale from 1 (not at all) to 5 (very much). Collecting repeated data of momentary experiences in daily life in this way is referred to as ecological momentary assessment. Responses to the questionnaire are used to tailor suggestions for the user to complete one of 12 possible therapeutic activities designed to disengage young people from RNT in the moment. In this way, Mello offers personalised intervention strategies matched to the level of stuck thinking (high or low), mood (positive or negative), context (at home or away from home), and activity (active or passive). Time of day (day or night) is also collected from the app and used to tailor the therapy activity recommendation. These rules underpinning which therapeutic activities are recommended to young people were determined based on reviews of the literature on RNT mechanisms, and input from clinicians and young people with lived experience. In addition to prompting therapy activities via the check-ins, participants can access all therapy activities on demand at any time via another section of the app contained within a profile, where they can also save their favourite therapy activities.

Therapy activities were derived from a meta-analysis of interventions targeting RNT in young people with depression and anxiety (Bell et al., in prep), as well as workshops with young people and clinicians outside the research group. A team of digital technology developers, researchers and clinicians within the research group then worked together to translate the evidence based intervention strategies identified from this meta-analysis into a digital format, following the requirements that these activities were: 1) engaging, 2) brief (5-10 minutes), and 3) likely to disrupt RNT in the moment. Further user testing with young people and clinicians then informed development and refinement of the therapy activities with a primary aim to ensure excellent user experience. These interactive, multimedia based activities primarily target disrupting the process of RNT by encouraging mindful detachment from negative thoughts through a number of cognitive behavioural strategies, including mindfulness, defusion, worry time, problem solving and attention training. Each activity takes approximately 5 minutes and involves guided audio or text options, with additional multimedia elements including interactive text entry, images and animations.

Following completion of a therapy activity, the participant is returned to the chat interface which collects follow up information about the level of RNT and ratings of how helpful the activity was. Contextual information collected within the check-in questionnaire feeds into a profile section of the app which provides insights into the relationship between RNT and contextual factors (mood, activity, location). This information is displayed as variables reported when stuck thinking is reported to be low (i.e. scores 1 or 2 on the check in scale) or high (i.e. scores 3 to 5 on the check in scale). The information on this page is only revealed once at least 7 check-ins are completed (33% of total number possible check-ins within one week) and at least one week of app use is completed, to ensure the feedback is representative of a spectrum of experiences. This component of the app targets improved self-awareness via self-monitoring and feedback, a key behavioural change strategy with evidence supporting clinical benefits for reducing RNT and improving mood conditions.

In addition to using Mello, engagement will be supported by weekly calls which will last approximately 15 minutes to participants from research assistants who check in on and encourage usage, and troubleshoot any problems. Whilst engagement with the app will be included as an outcome measure, this data will not be monitored during the course of the trial and addressed with participants.

Changes to the app during the course of the trial may be necessary to maintain optimum performance and app stability. In line with Mohr et al (2015), core active components of the intervention will not change during the trial. These include:

1) Notification and check in process, including the frequency of prompts and content of check ins, as well as the ability to check in on demand
2) Therapy activities and logic, including all content of the therapies, the logic linking check in contextual variables to activity recommendations
3) Ability to access therapy activities on demand via the home screen button, save favourites and schedule reminders for activities
4) About you screen displaying links between level of stuck thinking and contextual variables (i.e. check in data)

Features of the technology which directly affect usability (e.g. bug fixes, performance issues) will be addressed continuously during the trial but all core features will remain constant.

Mohr, D. C., Schueller, S. M., Riley, W. T., Brown, C. H., Cuijpers, P., Duan, N., ... & Cheung, K. (2015). Trials of intervention principles: evaluation methods for evolving behavioral intervention technologies. Journal of medical Internet research, 17(7), e166.
Intervention code [1] 322139 0
Behaviour
Comparator / control treatment
The control group will receive no access to the Mello treatment, i.e. there will not be a specific control activity for comparison. As participants are recruited from the community, they may be receiving care within a youth mental health service, including case management or psychological treatment from a private psychologist. Receipt of other mental health treatments will be allowed to continue and tracked throughout the trial.
Control group
Active

Outcomes
Primary outcome [1] 329483 0
All participants will be invited to complete the outcome assessment regardless of their level of exposure to the intervention.

Feasibility

Assessed as a composite of uptake into the trial (the proportion of eligible participants consenting to the study) and attrition from the trial (proportion of those who withdraw from the trial or lost to follow up relative to the number who were enrolled), determined through an audit of screening and enrolment logs
Timepoint [1] 329483 0
6 weeks post-intervention commencement
Primary outcome [2] 329485 0
Acceptability

Summary of scores from the Mobile Application Rating Scale – User version (uMARS; Stoyanov, Hides, Kavanagh, & Wilson, 2016).

Stoyanov, S. R., Hides, L., Kavanagh, D. J., & Wilson, H. (2016). Development and validation of the user version of the Mobile Application Rating Scale (uMARS). JMIR mHealth and uHealth, 4(2), e5849.
Timepoint [2] 329485 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [1] 402766 0
Severity of depressive symptoms: Total score of the Patient Health Questionnaire (PHQ-8; Richardson et al., 2010)

Richardson, L. P., McCauley, E., Grossman, D. C., McCarty, C. A., Richards, J., Russo, J. E., ... & Katon, W. (2010). Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics, 126(6), 1117-1123.
Timepoint [1] 402766 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [2] 402767 0
Severity of anxiety symptoms: Total score of the General Anxiety Disorder-7 (GAD-7; Mossman et al., 2017)

Mossman, S. A., Luft, M. J., Schroeder, H. K., Varney, S. T., Fleck, D. E., Barzman, D. H., ... & Strawn, J. R. (2017). The generalized anxiety disorder 7-item (GAD-7) scale in adolescents with generalized anxiety disorder: Signal detection and validation. Annals of clinical psychiatry: official journal of the American Academy of Clinical Psychiatrists, 29(4), 227.
Timepoint [2] 402767 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [3] 402768 0
Severity of repetitive negative thinking: Total score of the Perseverative Thinking Questionnaire (PTQ; Ehring et al., 2011)

Ehring, T., Zetsche, U., Weidacker, K., Wahl, K., Schönfeld, S., & Ehlers, A. (2011). The Perseverative Thinking Questionnaire (PTQ): Validation of a content-independent measure of repetitive negative thinking. Journal of behavior therapy and experimental psychiatry, 42(2), 225-232.
Timepoint [3] 402768 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [4] 403536 0
Severity of rumination: Total score of Ruminative Response Scale (RRS; Burwell et al., 2007)

Burwell, R. A., & Shirk, S. R. (2007). Subtypes of rumination in adolescence: Associations between brooding, reflection, depressive symptoms, and coping. Journal of Clinical Child and Adolescent Psychology, 36(1), 56-65.
Timepoint [4] 403536 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [5] 403537 0
Severity of worry: Total score of Penn State Worry Questionnaire (PSWQ; Crittendon et al., 2006)

Crittendon, J., & Hopko, D. R. (2006). Assessing worry in older and younger adults: Psychometric properties of an abbreviated Penn State Worry Questionnaire (PSWQ-A). Journal of anxiety disorders, 20(8), 1036-1054.
Timepoint [5] 403537 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [6] 403538 0
Cognitive defusion: Total score of Cognitive Fusion Questionnaire (CFQ; Sole et al., 2015)

Solé, E., Racine, M., Castarlenas, E., de la Vega, R., Tomé-Pires, C., Jensen, M., & Miró, J. (2015). The psychometric properties of the Cognitive Fusion Questionnaire in adolescents. European Journal of Psychological Assessment.
Timepoint [6] 403538 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [7] 403539 0
Cognitive reappraisal: Total score of the Reappraisal subscale of the Emotion Regulation Questionnaire (ERQ; Gullone & Taffe, 2012)

Gullone, E., & Taffe, J. (2012). The emotion regulation questionnaire for children and adolescents (ERQ–CA): a psychometric evaluation. Psychological assessment, 24(2), 409.
Timepoint [7] 403539 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [8] 403540 0
Wellbeing: Total score of Warwick-Edinburgh Mental Well-being Scale (WEMWBS; Hunter, Houghton & Wood, 2015)

Hunter, S. C., Houghton, S., & Wood, L. (2015). Positive mental well-being in australian adolescents: Evaluating the Warwick-Edinburgh mental well-being scale. The Educational and Developmental Psychologist, 32(2), 93-104.
Timepoint [8] 403540 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [9] 403541 0
Single item self-awareness and self-management measures: three single item scales measuring self-awareness of patterns in, and confidence in self-management of, RNT, using visual analogue scales from 0 (strongly disagree) to 100 (strongly agree):

a. I am aware of patterns in my negative thinking
b. I am aware of the things that affect my negative thinking patterns
c. I am confident in my ability to manage my negative thinking patterns
Timepoint [9] 403541 0
Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [10] 403542 0
Digital Therapeutic Alliance - Digital Working Alliance Inventory (D-WAI): 6 item measure capturing the degree of working alliance between the user and the app in order to meet personal goals (Goldberg et al., 2021).

Goldberg, S. B., Baldwin, S. A., Riordan, K. M., Torous, J., Dahl, C. J., Davidson, R. J., & Hirshberg, M. J. (2021). Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment, 10731911211015310.
Timepoint [10] 403542 0
6 weeks post-intervention commencement
Secondary outcome [11] 403543 0
Qualitative interview: qualitative interview questions with participants who receive access to Mello will capture themes regarding experiences of using the app (including potential helpful and unhelpful experiences), engagement, implementation, and feedback on features to inform system improvements.
Timepoint [11] 403543 0
6 weeks post-intervention commencement
Secondary outcome [12] 403544 0
Adverse events: Participants will be asked to describe any unwanted effects or negative events that they had experienced since commencing the trial, and the degree to which they believed the trial procedures were related to these events. All adverse events in both groups will be qualified according to the NHMRC Guidelines on Safety monitoring and reporting in clinical trials involving therapeutic goods. The proportion of trial related adverse events will be compared between the two samples. Coding of trial related adverse events will be completed by the research team following review of details collected during assessments.
Timepoint [12] 403544 0
3 weeks midpoint, and 6 weeks post-intervention commencement
Secondary outcome [13] 403545 0
App usage data: usage patterns of different components of the app, including check in usage and responses, therapy activity engagement (prompted and on-demand), and other passive data such as when the app is used. This will be tracked automatically and stored in a secure database.
Timepoint [13] 403545 0
Continuously during app use - i.e. from the point of allocation through to 6 weeks post assessment timepoint.

Eligibility
Key inclusion criteria
- Aged between 16 - 25 years
- Capacity to give informed consent
- Sufficient command of English language
- Own a smartphone capable of running the app
- Clinically high levels of RNT, measures by a score of 37 or more on the PTQ. This cutoff was chosen as the mean score of the clinical sample in the original validation study (Ehring et al., 2011), with guidance from the developers of the measure (correspondence with Ehring, 2021)
- Moderate to severe levels of depression OR anxiety, indicating caseness of MDD and GAD, measured by a score of 10 or above on the GAD-7 (Mossman et al., 2017) OR score of 10 or more on PHQ8 (Richardson et al., 2010)

Ehring, T., Zetsche, U., Weidacker, K., Wahl, K., Schönfeld, S., & Ehlers, A. (2011). The Perseverative Thinking Questionnaire (PTQ): Validation of a content-independent measure of repetitive negative thinking. Journal of behavior therapy and experimental psychiatry,
42(2), 225-232.

Mossman, S. A., Luft, M. J., Schroeder, H. K., Varney, S. T., Fleck, D. E., Barzman, D. H., ... & Strawn, J. R. (2017). The generalized anxiety disorder 7-item (GAD-7) scale in adolescents with generalized anxiety disorder: Signal detection and validation. Annals of
clinical psychiatry: official journal of the American Academy of Clinical Psychiatrists, 29(4), 227.

Richardson, L. P., McCauley, E., Grossman, D. C., McCarty, C. A., Richards, J., Russo, J. E., ... & Katon, W. (2010). Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics, 126(6), 1117-1123.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
- Current inpatients
- Receiving care from a crisis team
- Does not own a smartphone

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)
Random allocation will occur following baseline assessment completed by an automated computer program. The randomization sequence is concealed within the secure computer program, with allocation determined automatically and released when full eligibility criteria is met following the baseline assessment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by whether the participant is receiving current mental health treatment or not.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis of clinical outcome measures will be undertaken on an intention-to-treat basis. Generalised linear mixed modelling will be used to assess between-group differences in outcome scores at mid- and post- intervention timepoints, controlling for baseline scores.

The primary analyses will assess (1) treatment effects on repetitive negative thinking (PTQ), symptoms of depression (PHQ8), and anxiety (GAD7); (2) the relationship between the proposed primary mechanism measure (PTQ) and changes in symptom outcomes. Secondary analyses will examine treatment effects on other clinical outcomes measures.

Exploratory analysis of app data will (1) examine changes in intensity of stuck thinking (measured on a 5-point likert scale of intensity) over time; (2) explore potential relationships between change in PTQ scores and engagement metrics, likely using a LASSO regression depending on the nature of the data.

Qualitative analysis: The qualitative data will be analysed in accordance with Braun and Clarke's (2006) thematic analysis framework. This six-step analytical approach commences with data familiarisation, systematically identifying individual codes, grouping the identified codes into preliminary themes, defining and naming the final themes that appear frequently throughout the data set, and then using examples from the data to demonstrate each theme. Validity and rigour are maintained throughout the process through deep engagement with the data and regular reflexive discussion regarding the codes and subsequent themes.

Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative research in psychology, 3(2), 77-101.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2022
Actual
1/12/2021
Date of last participant enrolment
Anticipated
30/05/2022
Actual
Date of last data collection
Anticipated
11/07/2022
Actual
Sample size
Target
30
Accrual to date
44
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 308943 0
Charities/Societies/Foundations
Name [1] 308943 0
Telstra Foundation
Country [1] 308943 0
Australia
Primary sponsor type
University
Name
Orygen, University of Melbourne
Address
35 Poplar Rd
Parkville VIC 3052
Australia
Country
Australia
Secondary sponsor category [1] 309861 0
None
Name [1] 309861 0
Address [1] 309861 0
Country [1] 309861 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308830 0
The University of Melbourne HREC
Ethics committee address [1] 308830 0
The University of Melbourne
Grattan Street
Parkville VIC 3010
Australia
Ethics committee country [1] 308830 0
Australia
Date submitted for ethics approval [1] 308830 0
28/10/2021
Approval date [1] 308830 0
04/11/2021
Ethics approval number [1] 308830 0
Project ID: 21316

Summary
Brief summary
Anxiety and depressive disorders are amongst the most prevalent psychological disorders worldwide. Young people are at the highest risk of developing depression and anxiety as adolescence is a key developmental stage in which these disorders tend to emerge. Psychological intervention is the leading approach to treatment, however the efficacy of available approaches is limited and the right support is not available when and where it is needed most. Improving the efficacy of treatment might be achieved by providing access to digital interventions via smartphones which can provide support at key moments in daily life.

Based on the above rationale, a novel smartphone intervention was developed called Mello. Mello is the world’s first smartphone intervention providing targeted, personalised support for young people with depression and anxiety in daily life. The primary aim of this pilot RCT is to evaluate the feasibility and acceptability of Mello in a community sample of young people who experience depression and/or anxiety, with secondary aims examining whether using the app leads to improvements in mental health symptoms.
Trial website
None
Trial related presentations / publications
Public notes
none

Contacts
Principal investigator
Name 112046 0
Dr Imogen Bell
Address 112046 0
Orygen
35 Poplar Rd
Parkville VIC 3052
Country 112046 0
Australia
Phone 112046 0
+61 3 9966 9383
Fax 112046 0
Email 112046 0
[email protected]
Contact person for public queries
Name 112047 0
Dr Chelsea Arnold
Address 112047 0
Orygen
35 Poplar Rd
Parkville VIC 3052
Country 112047 0
Australia
Phone 112047 0
+61 452233209
Fax 112047 0
Email 112047 0
[email protected]
Contact person for scientific queries
Name 112048 0
Dr Chelsea Arnold
Address 112048 0
Orygen
35 Poplar Rd
Parkville VIC 3052
Country 112048 0
Australia
Phone 112048 0
+61 452233209
Fax 112048 0
Email 112048 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
SourceTitleYear of PublicationDOI
EmbaseA Personalized, Transdiagnostic Smartphone Intervention (Mello) Targeting Repetitive Negative Thinking in Young People With Depression and Anxiety: Pilot Randomized Controlled Trial.2023https://dx.doi.org/10.2196/47860
N.B. These documents automatically identified may not have been verified by the study sponsor.