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| ID | Type | Description | Link |
|---|---|---|---|
| DPRF-19/20-11079 | Other Identifier | King's College London | |
| 1074/MODREC/20 | Other Identifier | MODREC |
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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:
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.
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:
In addition to this, the feasibility trial will provide feedback from participants on their reactions to the app including:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Male
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | London | SE5 9RJ | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37639295 | Derived | 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. |
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| 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:
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| 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 |