Pilot trial of Mello: Investigating the effect of a targeted, personalised smartphone app on repetitive negative thinking in young people with depression and anxiety

Not Applicable

Recruiting

• Conditions: Depression; Anxiety; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12621001701819
• Lead Sponsor: Orygen, University of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-13
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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.

Exclusion Criteria

Exclusion criteria
- Current inpatients
- Receiving care from a crisis team
- Does not own a smartphone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All participants will be invited to complete the outcome assessment regardless of their level of exposure to the intervention. <br><br>Feasibility <br><br>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 [6 weeks post-intervention commencement];Acceptability<br><br>Summary of scores from the Mobile Application Rating Scale – User version (uMARS; Stoyanov, Hides, Kavanagh, & Wilson, 2016).<br><br>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.<br>[Baseline, 3 weeks midpoint, and 6 weeks post-intervention commencement]