MeT4VeT: Mental Health Toolkit for Military Veterans Trial

NCT05993676 | Completed

• 3 other identifiers: 583696DPRF-19/20-110791074/MODREC/20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 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).

Conditions

Mental Health Issue; Mental Health Wellness 1

Keywords

MeT4VeT

Outcome Measures

Primary Outcomes (15)

• Recruitment and retention: Number of interested participants

  Calculate the total number of participants contacting the study team to express an interest in taking part in the study.

  5month recruitment period

• Recruitment and retention: Number of eligible participants

  Calculate the total number of participants contacting the study team to express an interest in taking part in the study who are eligible to take part. Calculate this as a percentage of total number of interested participants.

  5month recruitment period

• Recruitment and retention: Response rate

  Calculate the total number of eligible participants who went onto complete the consent form. Calculate this as a percentage of total number of eligible participants.

  5month recruitment period

• Recruitment and retention: One month follow up retention rates

  Calculate the total number of participants enrolled onto the study who went onto complete the 1month follow up. Calculate this as a percentage of total number of enrolled participants.

  Baseline plus 1 months (28 days), end of trial period

• Recruitment and retention 4: Three month follow up retention rates

  Calculate the total number of participants enrolled onto the study who went onto complete the 3month follow up. Calculate this as a percentage of total number of enrolled participants.

  Baseline plus 3 months (84 days)

• Recruitment and retention 5: Comparability of sample to MOD personnel

  Comparability of sample to Ministry of Defence statistics for major sub-groups of veterans (age, service branch, rank)

  Baseline plus 3 months (84 days)

• Trial procedures and outcome measures: Technical delivery

  Evaluation of the technical delivery of the app was gained through gathering feedback from developers and participants, identifying any potential technical issues

  Baseline plus 1 months (28 days), end of trial period

• Trial procedures and outcome measures: GHQ12

  The General Health Questionnaire (GHQ-12) is a measure of common mental disorders such as anxiety and depression. It is a 12-item self-report questionnaire measured on a 4-point scale. Scores range from 0-12 with a score of 4 or more indicative of probable mental ill health.The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.

  Baseline plus 3 months (84 days)

• Trial procedures and outcome measures: PCL-C

  To evaluate symptoms of PTSD, the PTSD Checklist Civilian version (PCL-C) was used. It is a 17-item self-report questionnaire, measured on a 5-point scale from (1) not at all to (5) extremely. Scores range from 17 to 85, scores over 50 are indicative of possible PTSD. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.

  Baseline plus 3 months (84 days)

• Trial procedures and outcome measures: Well-being

  Warwick Edinburgh Mental Well-being Scale (WEMWBS) measures mental well-being within the previous two weeks and is a 14-item self-report questionnaire measured on a 5-point scale from (1) none of the time to (5) all of the time. Scores range from 14 to 70 with higher scores indicative of greater mental well being. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.

  Baseline plus 3 months (84 days)

• Trial procedures and outcome measures: WHO QOL-BREF

  Quality of life was assessed using the World Health Organization Quality of Life Assessment (WHOQOL-BREF), a 26-item self-report questionnaire divided into four domains: physical health; social relationships; psychological health; environmental health. It is measured on a 5-point scale, with a score of 0-100 calculated, where 100 equates to the best possible state of health. The difference between scores at baseline, day 28 (1month) and day 84 (3months) were calculated.

  Baseline plus 3 months (84 days)

• Trial procedures and outcome measures: Completion rates

  Examination of the feasibility of using the app to collection outcome measures was assessed via completion rates for each of the questionnaires (baseline; 1month follow up; 3month follow up)

  Baseline plus 3 months (84 days)

• Trial procedures and outcome measures: Sample size

  Sample size estimates for a future randomised control trial were assessed via changes in GHQ12 scores from baseline to 3month follow up.

  Baseline plus 3 months (84 days)

• Acceptability and usability: Usage

  App usage data were collected from Google Analytics via Firebase (CA, USA) and included information such as the number of times the app was opened, the duration of each app use and the number of times specific sections of the app were used.

  Baseline plus 1 month (28 days), end of initial trial period

• Acceptability and usability: MAUQ

  The mHealth App Usability Questionnaire (MAUQ) was used to assess app usability at day 28. A 16 item version of the MAUQ of the self-report questionnaire was used, measured on a 7-point scale ranging from strongly disagree (1) to strongly agree (7). Participant responses were aggregated into overall usability and three other domains: ease of use and satisfaction, interface and functionality, and usefulness. The mean total score and the mean of each three domains were scored out of seven, with a score of four indicating a neutral response and higher scores indicating greater app usability.

  Baseline plus 1 month (28 days), end of initial trial period

Study Arms (2)

Control

SHAM COMPARATOR

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.

Behavioral: MeT4VeT mobile phone app: control

Intervention

ACTIVE COMPARATOR

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.

Behavioral: MeT4VeT mobile phone app: intervention

Interventions

MeT4VeT mobile phone app: control 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

Control

MeT4VeT mobile phone app: intervention 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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Those who display current suicidal ideation / self-harm

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

London, SE5 9RJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 37639295 DERIVED

Study Officials

• Nicola Fear, Prof

  King's College London

  PRINCIPAL INVESTIGATOR

• Sharon Stevelink, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

• Neil Greenberg, Prof

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 15, 2023
• Study Start: January 15, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: August 15, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)