My Symptoms Young - a New Internet-based Programme for Young People With Persistent Physical Symptoms in Primary Care: Exploration of Effect and Health Literacy Characteristics Among Users

Condition(s) studied

Investigational drug(s) / intervention(s)

My Symptoms Young - an internet-based self-help programme for young people with persistent physical symptoms: My Symptoms Young is advanced internet-based self-help programme consisting of seven modules, a closing module on relapse prevention, and a module targeting close relatives plus four tools: don't break the chain, goal setting staircase, symptom registration and notebook for reflections. The seven modules target symptom understanding, physical energy, resources and strains, thoughts, feelings, values, and self-care. The program is accessed through a website using either a computer, tablet or mobile phone.

Study summary

The research programme is an ambitious effort aiming to improve overall functioning and quality of life for young people with bodily distress. Bodily distress is a condition characterized by persistent physical symptoms (PPS), such as headache, nausea or abdominal pain, not explained by a well-defined disease. Over time, PPS can develop into a functional disorder, with detrimental impact on the young person's everyday life and opportunities. Thus, early intervention is crucial, but at present, access to specialized treatment of PPS to young people in primary care is very limited.

The investigators have developed the internet-based self-help programme My Symptoms Young as a new digital solution for early intervention of PPS. The intervention was developed using a high degree of user involvement (young people with PPS) and are now ready to be tested.

The goal of this clinical trial is to learn and preliminary test the possible effects of the internet-based self-help intervention program My Symptoms Young in young people aged 15-25 who experience PPS (physical symptoms presenting for \>3 months). The main question the investigators aim to answer is:

* What are the potential effects of My Symptoms Young In addition, the investigators aim to investigate if participation in the program can reduce overall symptom intensity and interference with daily activity in young people's lives. Finally, the investigators aim to examine if individual levels of health literacy (HL) and eHealth literacy (eHL) will modify the potential effects.
* The primary outcomes will be symptom intensity and symptom interference with daily activities
* The primary hypothesis will be: Symptom intensity and interference with daily activities will improve after the treatment with My Symptoms Young. The effect will be modified by levels of HL and aspects of eHL.

The investigators will include a total of 62 participants. The are no comparison group. Participants will be recruited from a health care professional in primary care (either general practitioner or practising pediatrician; from now on referred to as HCP). The HCP will determine whether referral to the My Symptoms Young programme is relevant. To guide this evaluation, the HCP will use pre-defined inclusion and exclusion criteria for participation. When a young person has been referred to the project group, a research assistent from the investigator group will contact the young person to provide more detailed information on the research project and the programme. If written consent is obtained, the young person will receive access to the programme. Throughout the intervention, the referring HCP is fully responsible for the health care of the young person. Referral and participation will be documented in the participants' primary care medical journal. If participants experience physical or psychological challenges during the project, they are advised to contact the referring HCP, i.e. the responsible healthcare provider.

The programme is accessed through a website, using either tablet, mobile or computer. It consists of seven modules, a closing module on relapse prevention, and a module targeting close relatives plus four tools: don't break the chain, goal setting staircase, symptom registration and notebook for reflections. The seven modules target symptom understanding, physical energy, resources and strains, thoughts, feelings, values, and self-care. Participants will gradually gain access to the modules. The programme encourages young persons to work with various exercises throughout the different modules but with freedom to choose what to work with. Besides text and exercises, the programme also includes explanatory animations, audio files on case stories, audio files on brief meditations and videos on physical exercises.

At first login (baseline), the participant will need to complete a set of questionnaires to access the programme. When completed the participant receives access to the programme. The researcher will follow up with participants by phone after one week if they have not logged into the programme and after three weeks if they have logged in but remained inactive. Participants can decide individually how long they wish to use the programme, but they are encouraged and recommended to engage actively at least twice a week for a minimum of 30 minutes. Participants will have access to the program for a total of 8 weeks. They will fill in questionnaires at three time points: Baseline (first login to the programme), End of Treatment (8 weeks after baseline) and 3 months after End of Treatment.

Eligibility

Primary outcome measure(s)

• Symptom intensity and interference — Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment
  The primary outcomes will be symptom intensity and symptom interference with daily activities as measured by a numeric rating scale (NRS) ranging from 0 to 10. For symptom intensity, the young person rates the overall intensity of their bodily symptoms within the past 7 days where 0 represents 'no symptoms at all' and 10 'worst possible symptoms'. For symptom interference, the young person indicates their bodily symptoms' interference with daily activities within the past 7 days, 0 will represent 'Not at all' and 10 'Interfered completely'

Trial sites (1)

More Aarhus University Hospital trials in Denmark

Other trials for the same condition