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Adaptation of the My Food and Mood app for adults at risk of Posttraumatic Stress Disorder (PTSD): Lived experience feedback, engagement and prototype design ideas

Adaptation of the My Food and Mood app for adults at risk of Posttraumatic Stress Disorder (PTSD): Lived experience feedback, engagement and prototype design ideas

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001662853
Enrollment
24
Registered
2021-12-03
Start date
2021-12-20
Completion date
2022-01-10
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Post-Traumatic Stress Disorder (PTSD) is a debilitating and costly condition. Conventional treatments are insufficient and fail to adequately address comorbid conditions such as coronary heart disease and diabetes. Dietary intervention is a well-established approach in treatment of physical conditions whereas building evidence suggests improving diet quality may address factors that are maintaining and exacerbating PTSD. However, current research in dietary improvement programs for those at risk of PTSD is limited in quantity and quality. We aim to adapt the My Food and Mood app for adults with PTSD symptoms, using a co-design approach with those with lived experience of PTSD. 24 adults at risk of current PTSD (i.e. with an elevated score on a PTSD symptoms measure) will undertake a consumer survey, trial the My Food and Mood app and provide feedback in an online group meeting. This information will be used to develop the Healthy Eating Lifestyle Program (HELP) app to pilot. This project will provide a solid foundation for the co-development and optimisation of a digital program targeting diet quality improvement for those at risk of PTSD. Given the relatively high prevalence of PTSD and its enormous individual and societal costs, an online self-help approach could provide a pragmatic and effective adjunct treatment strategy. Outcomes of the project will inform funding applications for a large online RCT to establish the comparative efficacy of dietary interventions for PTSD populations.

Interventions

Our overall project is comprised of two sub-studies. The first sub-study is outlined in this record and entails Phases 1 and 2 of our project. This is a single group intervention. We will recruit a minimum of 16 adults (target of 20) at risk of PTSD to undertake Phases 1 and 2. Recruitment and participation for this study are completely online. PHASE 1 Phase 1 asks participants to review the PLS, provide consent, answer questions for eligibility screening (10 – 15 minutes) and undertake an I

Our overall project is comprised of two sub-studies. The first sub-study is outlined in this record and entails Phases 1 and 2 of our project. This is a single group intervention. We will recruit a minimum of 16 adults (target of 20) at risk of PTSD to undertake Phases 1 and 2. Recruitment and participation for this study are completely online. PHASE 1 Phase 1 asks participants to review the PLS, provide consent, answer questions for eligibility screening (10 – 15 minutes) and undertake an Initial Consumer Input Survey (10 – 15 minutes). Participants will then be provided with two-week access to trial the My Food & Mood program. The My Food & Mood program is a modularised educational dietary program designed to support individuals with depression to adopt a Mediterranean style diet. My Food & Mood program is a smartphone application. It contains modularised educational dietary videos and activities about healthy eating for mental health. Participants can use the app to record the overall quality of their meals and snacks (Food), generally how they are feeling each day (Mood), a range of lifestyle activities (Lifestyle), a shopping list and dietary goals. The app will then generate a bar chart of their weekly Food together with goals achieved and lifestyle choices to help them look at these patterns over time. The application will support their knowledge and skill development in shopping, cooking and consuming foods consistent with a Mediterranean style diet. Participants decide how much or how little they use the application. Anticipated usage times are drawn from the cohort study (Young et al. 2021) which optimised and evaluated the My Food and Mood app version utilised in this study. For an average of 3.6 weeks total engagement, participants had a total usage time of 1 hour 52 minutes, for 30 active sessions for an average of 4 minutes 55 seconds per session. Most participation occurred within the first two weeks. We anticipate similar average times per session in this study and predict approximately 1.5 hours total usage time. The total time for videos is 52 minutes 40 seconds. Participants receive a daily notification at 7 pm that says "Have you recorded your food & mood for today?" Participants are provided with an instructional video and an email with instructions. Participants are advised in their Plain Language Statement that their usage behaviour will be tracked via data analytics. App data tracked will include (1) weeks engaged, (2) total usage time, (3) total time key activities, (4) number of active sessions, (5) average time per session, (6) per protocol percentage, (7) goals completed and (8) percentage of videos watched. This data will serve as a measure of engagement in the program. PHASE 2 For Phase 2 participants will take part in an online Consumer Input Group Meeting (1 hour Zoom meeting). Here they participate in tasks such as idea generation (Brainstorming), and reviews/feedback of the My Food & Mood program. At the end of the My Food and Mood app trial period, participants will receive an automated email advising of zoom meeting Consumer Input Group details to enable participation in Phase 2 of this project. This email includes information about the time and date of the meeting, login instructions, and Consumer Input Group procedures. It is anticipated that the zoom meeting will be booked for 1 week after the 10th and 20th participant completes their two-week app trial period. A reminder email will be sent to participants one day and one hour before each Consumer Input Group meeting. Participants will be requested to have their voice and camera activated during the Consumer Input Group meeting but may elect to have their camera off, or to leave the meeting at any time. The Consumer Input Group meeting will be recorded to ensure accurate data collection. Participants will be asked to consent (via a meeting pop up box) to session recording at the beginning of the video conference. We will run two consumer input group experiences, with each group containing at least 8-12 participants. These experiences will occur electronically via Zoom video conferencing facilities which allow real-time voice and visual group interactions. Consumer input group experiences will require participants to provide verbal responses and participate in a facilitated group discussion regarding a series of structured questions. Participants will be asked about their experience and use of the My Food & Mood program, factors that helped or hindered their motivation, suggestions for improvements, and changes they would like to see for those who are at risk of PTSD. Consumer input group experiences will be organised and facilitated by student investigator, Gina Howland, who is an experienced and practising Clinical Psychologist.

Sponsors

Deakin University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria are: -18 years or over -Reside in Australia -At risk of PTSD (Score 33 or higher on PCL-5)

Exclusion criteria

Exclusion criteria are: -Indicate they have no dietary autonomy -Indicate they are on a medically prescribed diet -Low computer literacy -Low English literacy -No Internet or smartphone access

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026