MeT4VeT: Mental Health Toolkit for Military Veterans Trial

King's College London

Status: Completed

Conditions: Mental Health Wellness 1; Mental Health Issue

Treatments: Behavioral: MeT4VeT mobile phone app: intervention; Behavioral: MeT4VeT mobile phone app: control

Study type: Interventional

Funder types: Other

Identifiers

NCT05993676

583696

DPRF-19/20-11079 (Other Identifier)

1074/MODREC/20 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males
• Own a smartphone
• Served at least 2 years in the UK Armed Forces
• Left the UK Armed Forces within the last 2 years
• Not currently undertaking formal mental health treatment (mental health therapy by a medical professional)
• Indicate a degree of mental health distress (assessed via a score of two or more on the GHQ-12

Exclusion criteria

• Those who display current suicidal ideation / self-harm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Control

Sham Comparator group

Description:

The control group received an app containing only signposting information about a range of statutory and third sector organisations that focused on veterans' mental health.

Treatment:

Behavioral: MeT4VeT mobile phone app: control

Intervention

Active Comparator group

Description:

The intervention group will receive a 'full' version of the app over the 1month trial period. The app consists of five core elements: 1. Personas developed as an aide to the provision of psycho-education on how mental health difficulties might look in real life and to help participants identify symptoms of mental health difficulties in themselves. 2. Daily life goals employing behavioural activation principles to encourage users to set a series of small tasks to help them achieve larger goals in different areas of their life e.g. work, family, physical health. 3. Self-help tools to provide participants with a range of resources that they can use independently to help them manage symptoms of mental ill-health they may be experiencing. 4. Tracking tools to allow users to monitor their own mental health and to see their progress across the elements of the app. 5. A schedule of daily notifications to encourage participants to continue to engage with the app.

Treatment:

Behavioral: MeT4VeT mobile phone app: intervention