MeT4VeT: Mental Health Toolkit for Military Veterans Trial

Mental Health Issue Clinical Trial

Official title: A Feasibility Trial of a Smartphone App to Support the Mental Health of UK Armed Forces Veterans (MeT4VeT)

Status Completed

Clinical Trial Summary

The proposed research involves the running of a feasibility trial to assess a smart phone app designed to support military veterans (as they transition out of the Armed Forces) experiencing mental health difficulties to monitor and manage their mental health, encouraging them to seek formal mental healthcare services if required. The trial will compare participants who are provided with the 'full' app (case group) with participants who receive a 'signposting only' feature free smartphone app, receiving the 'full' app 3months later once the research trial is over (control group).

The feasibility trial has two core aims:

1. To provide initial assessment of the practicality of testing the app Running of the feasibility trial will provide key information on the practical delivery of the app and measurement processes; enable an estimation of recruitment and retention of participants; as well as trialling a series of outcome measures. All participants taking part in the trial will be asked to complete a short (20minute) in app survey at three time points: baseline; baseline plus 1month; baseline plus 3months. This questionnaire will collect demographic information and employ a number of well-being and quality of life measures.

2. To provide initial feedback on the app The trial will qualitatively evaluate how those in the case group use the 'full' app (via collection of app usage data over a 1month trial period) and how easy to interact with, and potentially helpful, they consider the app might be (via a short 30minute telephone interview at the end of the 1month app trial period).

If the trial indicates that the app is acceptable and feasible then a full randomized control trial (subject to funding) will be run to assess the effectiveness of the app in supporting mental health. If proven acceptable then the app would be made freely available to all.

Clinical Trial Description

In line with the Medical Research Council Complex Intervention Framework (Medical Research Council) the feasibility stage of developing an intervention is focused on three areas to assess the practical aspects of testing an intervention including:

• Testing procedures (technical app delivery; measurement processes)

• Estimating recruitment and retention (number of eligible/ interested participants; drop-out rates)

• Determining sample size (testing main outcome measures to determine appropriate sample size for a later randomised control trial)

In addition to this, the feasibility trial will provide feedback from participants on their reactions to the app including:

• Actual use of the app

• Satisfaction with the app

• How appropriate they believe the app to be

• Intent for continued use

This toolkit will provide those who participate in the research with an additional support tool which may help them to manage their own mental health during a potentially challenging period (as they transition out of the Armed Forces) and help them to identify a need for more formal support if required. ;

Related Conditions & MeSH terms

• Mental Health Issue
• Mental Health Wellness 1

• NCT number: NCT05993676
• Study type: Interventional
• Source: King's College London
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Completion date: December 5, 2022