Mental Health IssueNCT05993676

MeT4VeT: Mental Health Toolkit for Military Veterans Trial

A study testing MeT4VeT mobile phone app: intervention in people with Mental Health Issue and Mental Health Wellness 1, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Mental Health Issue, Mental Health Wellness 1
What is being tested?: MeT4VeT mobile phone app: intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited Kingdom
Study dates: 15 Jan 2021to 5 Dec 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Those who display current suicidal ideation / self-harm

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

King's College London
London, SE5 9RJ

Other trials in United Kingdom

About this study

Official title: A Feasibility Trial of a Smartphone App to Support the Mental Health of UK Armed Forces Veterans (MeT4VeT)

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:

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.
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.

Read the 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.

Conditions: Mental Health Issue, Mental Health Wellness 1
Being tested: MeT4VeT mobile phone app: control, MeT4VeT mobile phone app: intervention
Keywords: MeT4VeT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MeT4VeT mobile phone app: controlBehavioural
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
MeT4VeT mobile phone app: interventionBehavioural
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

Study groups in NCT05993676
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: MeT4VeT mobile phone app: intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 20215 Dec 2022

First posted15 Aug 2023
Study start15 Jan 2021
Primary completion5 Dec 2022
Study completion5 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mental Health IssueStudies of the same condition, open and under way.
More trials run by King's College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05993676
Sponsor's protocol ID: 583696
Other IDs: DPRF-19/20-11079, 1074/MODREC/20
Status last verified: Jul 2023
First submitted: 25 Jul 2023
Last updated: 15 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37639295

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure

All Mental Health Issue trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Feasibility Trial of a Smartphone App to Support the Mental Health of UK Armed Forces Veterans (MeT4VeT)
ClinicalTrials.gov ID: NCT05993676
Acronym / sponsor ID: 583696
Conditions: Mental Health Issue, Mental Health Wellness 1
Keywords: MeT4VeT
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: King's College LondonUniversity, hospital or other
Study start: 15 Jan 2021 (actual)
Primary completion: 5 Dec 2022 (actual)
Study completion: 5 Dec 2022 (actual)
First posted: 15 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The feasibility trial has two core aims:

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.
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).

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Control	Sham comparator	Behavioral: MeT4VeT mobile phone app: controlThe control group received an app containing only signposting information about a range of statutory and third sector organisations that focused on veterans' mental health.
Intervention	Active comparator	Behavioral: MeT4VeT mobile phone app: interventionThe 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.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (1 listed)

Those who display current suicidal ideation / self-harm

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MeT4VeT mobile phone app: controlThe 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	Behavioural	Control
MeT4VeT mobile phone app: interventionThe 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	Behavioural	Intervention

Primary outcome

Recruitment and retention: Number of interested participants
Time frame: 5month recruitment period
Calculate the total number of participants contacting the study team to express an interest in taking part in the study.
Recruitment and retention: Number of eligible participants
Time frame: 5month recruitment period
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.
Recruitment and retention: Response rate
Time frame: 5month recruitment period
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.
Recruitment and retention: One month follow up retention rates
Time frame: Baseline plus 1 months (28 days), end of trial period
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.
Recruitment and retention 4: Three month follow up retention rates
Time frame: Baseline plus 3 months (84 days)
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.
Recruitment and retention 5: Comparability of sample to MOD personnel
Time frame: Baseline plus 3 months (84 days)
Comparability of sample to Ministry of Defence statistics for major sub-groups of veterans (age, service branch, rank)
Trial procedures and outcome measures: Technical delivery
Time frame: Baseline plus 1 months (28 days), end of trial period
Evaluation of the technical delivery of the app was gained through gathering feedback from developers and participants, identifying any potential technical issues
Trial procedures and outcome measures: GHQ12
Time frame: Baseline plus 3 months (84 days)
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.
Trial procedures and outcome measures: PCL-C
Time frame: Baseline plus 3 months (84 days)
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.
Trial procedures and outcome measures: Well-being
Time frame: Baseline plus 3 months (84 days)
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.
Trial procedures and outcome measures: WHO QOL-BREF
Time frame: Baseline plus 3 months (84 days)
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.
Trial procedures and outcome measures: Completion rates
Time frame: Baseline plus 3 months (84 days)
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)
Trial procedures and outcome measures: Sample size
Time frame: Baseline plus 3 months (84 days)
Sample size estimates for a future randomised control trial were assessed via changes in GHQ12 scores from baseline to 3month follow up.
Acceptability and usability: Usage
Time frame: Baseline plus 1 month (28 days), end of initial trial period
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.
Acceptability and usability: MAUQ
Time frame: Baseline plus 1 month (28 days), end of initial trial period
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
Derived from this study: PubMed 37639295Parkes 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.
Individual participant dataSharing planned: No

Related trials for Mental Health Issue

Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nicola Fear, Prof principal investigator

King's College London

Sharon Stevelink, PhD principal investigator

King's College London

Neil Greenberg, Prof principal investigator

King's College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MeT4VeT mobile phone app: intervention in people with Mental Health Issue and Mental Health Wellness 1, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment and retention: Number of interested participants (time frame: 5month recruitment period). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05993676, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2023.