Clinical trial NCT05993676: MeT4VeT: Mental Health Toolkit for Military Veterans Trial
Official title: A Feasibility Trial of a Smartphone App to Support the Mental Health of UK Armed Forces Veterans (MeT4VeT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Mental Health Wellness 1
Keywords: MeT4VeT
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and retention: Number of interested participants
timeFrame: 5month recruitment period
measure: Recruitment and retention: Number of eligible participants
timeFrame: 5month recruitment period
measure: Recruitment and retention: Response rate
timeFrame: 5month recruitment period
measure: Recruitment and retention: One month follow up retention rates
timeFrame: Baseline plus 1 months (28 days), end of trial period
measure: Recruitment and retention 4: Three month follow up retention rates
timeFrame: Baseline plus 3 months (84 days)
measure: Recruitment and retention 5: Comparability of sample to MOD personnel
timeFrame: Baseline plus 3 months (84 days)
measure: Trial procedures and outcome measures: Technical delivery
timeFrame: Baseline plus 1 months (28 days), end of trial period
measure: Trial procedures and outcome measures: GHQ12
timeFrame: Baseline plus 3 months (84 days)
measure: Trial procedures and outcome measures: PCL-C
timeFrame: Baseline plus 3 months (84 days)
measure: Trial procedures and outcome measures: Well-being
timeFrame: Baseline plus 3 months (84 days)
measure: Trial procedures and outcome measures: WHO QOL-BREF
timeFrame: Baseline plus 3 months (84 days)
measure: Trial procedures and outcome measures: Completion rates
timeFrame: Baseline plus 3 months (84 days)
measure: Trial procedures and outcome measures: Sample size
timeFrame: Baseline plus 3 months (84 days)
measure: Acceptability and usability: Usage
timeFrame: Baseline plus 1 month (28 days), end of initial trial period
measure: Acceptability and usability: MAUQ
timeFrame: Baseline plus 1 month (28 days), end of initial trial period
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Nicola Fear, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Sharon Stevelink, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Neil Greenberg, Prof
role: PRINCIPAL_INVESTIGATOR
References: