MeT4VeT: Mental Health Toolkit for Military Veterans Trial

NCT ID: NCT05993676

Last Updated: 2023-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2022-12-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Health Issue Mental Health Wellness 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

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.

Group Type SHAM_COMPARATOR

MeT4VeT mobile phone app: control

Intervention Type BEHAVIORAL

The control/ sham comparator arm of the Mental Health Toolkit for Veterans (MeT4VeT) smart phone app contains only signposting information around support services available to military veterans

Intervention

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.

Group Type ACTIVE_COMPARATOR

MeT4VeT mobile phone app: intervention

Intervention Type BEHAVIORAL

The Mental Health Toolkit for Veterans (MeT4VeT) smart phone app has been developed through careful and close collaboration with military veterans and key providers of veterans' mental healthcare services. The aim of this app is to provide both a degree of education to support military veterans' understanding of mental health and foster self-recognition and management of mental health symptoms whilst also encouraging those who need it to seek more formal support.

The elements of the app have been chosen for inclusion as they represent the intersection between:

1. Core components of cognitive behavioural therapy, the theoretical framework underwriting the app
2. Behaviour change constructs

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MeT4VeT mobile phone app: control

The control/ sham comparator arm of the Mental Health Toolkit for Veterans (MeT4VeT) smart phone app contains only signposting information around support services available to military veterans

Intervention Type BEHAVIORAL

MeT4VeT mobile phone app: intervention

The Mental Health Toolkit for Veterans (MeT4VeT) smart phone app has been developed through careful and close collaboration with military veterans and key providers of veterans' mental healthcare services. The aim of this app is to provide both a degree of education to support military veterans' understanding of mental health and foster self-recognition and management of mental health symptoms whilst also encouraging those who need it to seek more formal support.

The elements of the app have been chosen for inclusion as they represent the intersection between:

1. Core components of cognitive behavioural therapy, the theoretical framework underwriting the app
2. Behaviour change constructs

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King's College London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicola Fear, Prof

Role: PRINCIPAL_INVESTIGATOR

King's College London

Sharon Stevelink, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Neil Greenberg, Prof

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

King's College London

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Parkes S, Croak B, Brooks SK, Stevelink SAM, Leightley D, Fear NT, Rafferty L, Greenberg N. Evaluating a Smartphone App (MeT4VeT) to Support the Mental Health of UK Armed Forces Veterans: Feasibility Randomized Controlled Trial. JMIR Ment Health. 2023 Aug 28;10:e46508. doi: 10.2196/46508.

Reference Type DERIVED
PMID: 37639295 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DPRF-19/20-11079

Identifier Type: OTHER

Identifier Source: secondary_id

1074/MODREC/20

Identifier Type: OTHER

Identifier Source: secondary_id

583696

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Self-help App and Wellbeing
NCT04911803 COMPLETED NA