Trial · NCT07912515
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
NCT07912515, Not applicable, Recruiting, Aarhus University Hospital
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. 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. Trials, record NCT07912515. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912515
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT07912515
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 62 participants, estimated
- Lead sponsor
- Aarhus University Hospital
- Conditions
- Persistent Physical Symptoms (PPS), Bodily Distress Syndrome, Health Literacy, eHealth Literacy
- Interventions
- My Symptoms Young - an internet-based self-help programme for young people with persistent physical symptoms
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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' |
| Secondary | SF-36 | Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment | Two items from the SF-36 score will be used to measure overall global health. The first item is "In general, would you say your health is" and is rated on a Likert scale 1 (excellent), 2 (very good), 3 (good), 4 (fair) and 5 (poor). The second item is "Compared to one year ago, how would you rate your health in general now". The item is rated on a Likert scale ranging from 1 (much better now than one year ago), 2 (somewhat better now than one year ago), 3 (about the same), 4 (somewhat worse now than one year ago) and 5 (much worse now than one year ago) |
| Secondary | The Bodily Distress Syndrome (BDS) Checklist | Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment | The Bodily Distress Syndrome (BDS) Checklist will be administered as a measure of physical symptom burden. The BDS Checklist explores the presence of 25 symptoms representing four symptom clusters: cardiopulmonary, gastrointestinal, musculoskeletal, and general symptoms. The young person will be asked to rate on a 5-point Likert-type scale how much they have been bothered by each of the 25 listed symptoms within the past four weeks. Response categories are: 'not at all' (0), 'a bit' (1), 'somewhat' (2), 'quite a bit' (3) and 'a lot' (4). The sum score will be calculated by adding the single item scores from the 25 items (range 0-100) with higher scores representing higher symptom burden. |
| Secondary | The Limitation Index (LI-index) | Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment | Impact on physical functioning will be measured using the Limitation Index (LI-index). The questionnaire is a modified version of the Pain Interference Index (PII), which emphasizes symptoms beyond just pain. The PII was developed as a brief instrument to assess the impact of pain on behaviours and the extent to which long-standing pain interferes with essential aspects of daily life. The modified LI-index consist of six items that measures the extent to which physical symptoms have limited behaviour within the past four weeks. The items are rated on a Likert scale ranging from 0 ('not at all') to 6 ('very much'). |
| Secondary | Patient Global Impression of Change (PGIC) | End of Treatment (8 weeks after baseline), 3-months after End of Treatment | Self-rated global health change will be obtained using the Patient Global Impression of Change (PGIC) scale. The young person will be asked to rate current health condition on a five-point Likert scale ranging from much worse to much better health. For statistical analysis, the scale will be collapsed into three categories representing much improved, minimal or no change and much deteriorated health. Based on the NRS of symptom intensity, the proportion of young persons that has clinically significantly improved will be calculated. Clinically significant improvement will be defined as a decrease in symptom intensity of ≥2.0 points. Adverse events will be defined as a 50% worsening of symptoms as measured by the NRS for symptom intensity. |
| Secondary | The Brief Illness Perception Questionnaire (B-IPQ) | Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment | To measure illness perception, an adapted version of the Brief Illness Perception Questionnaire (B-IPQ) will be used. The original B-IPQ has 9 items; 5 items assess cognitive illness representations such as consequences, timeline, personal and treatment control, and identity. Two items assess emotional representations such as concerns and emotions and finally, illness comprehensibility and illness causes are assessed by one item respectively. Apart from illness causes, each item is scored on a scale ranging from 0-10. PPS is not an illness per se and young persons with PPS may not have a diagnosis. Therefore, the investigators have replaced the term 'illness' with 'symptoms'. Therefore, one item 'How much do you experience symptoms from your illness?' has been removed. A total score (range 0-70) will be calculated with lower scores indicating more positive illness perceptions. |
| Secondary | The Behavior Related to Illness Questionnaire (BRIQ) | Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment | Two subscales from the Behaviour Related to Illness Questionnaire (BRIQ) will be applied to measure behavioural responses to PPS within the past four weeks. The subscale "Limiting behaviour" comprises 6 items and the subscale "All or nothing behaviour" 7 items. All items are scored on a 5-point Likert-type scale representing the frequency of certain behaviours and ranging from 0 ('not at all') to 4 ('every day'). For each subscale, a sum score will be calculated with lower scores indicating a more adaptive symptom behaviour. |
| Secondary | Pain Self-Efficacy Questionnaire (PSEQ) | Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment | To measure participants' current confidence in performing activities in the context of PPS, an adapted version of the Pain Self-Efficacy Questionnaire (PSEQ) is used. To address young people with PPS, the term 'pain' has been replaced by 'symptoms'. The PSEQ comprises ten items that are scored on a 7-point Likert-type scale ranging from 0 ('not at all confident') to 6 ('completely confident'). A sum score (range 0-60) will be calculated. |
| Secondary | Whiteley Index (WI-6-R) | Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment | Illness worry is measured using the revised version of the six-item Whiteley Index (WI-6-R). The WI-6-R measures to which extent the respondent within the past four weeks has been bothered by fear of being ill and has attributed current bodily sensations to physical disease. The six items are rated on a Likert-type scale ranging from 0 ('not at all') to 4 ('very much'). A sum score (range 0-24) will be calculated with higher scores indicating higher illness worry. |
| Secondary | Symptom Checklist (SCL-90) | Baseline (first login in programme), End of Treatment (8 weeks after baseline), 3-months after End of Treatment | Impairment by anxiety and depression will be measured with subscales from the Danish version of the Hopkins Symptom Checklist (SCL-90), the SCL-ANX4 for anxiety and the SCL-DEP6 for depression. Each item in these subscales relates to the past four weeks and is rated on a five-point Likert scale of distress ranging from 'not at all' (0) to 'very much' (4). The total sum scores will be calculated for each subscale (range: anxiety 0-16, depression 0-24). Higher scores indicate higher impairment. Hopelessness will be measured by one item from the SCL-90: "During the last four weeks, how much were you bothered by feelings of hopelessness about the future?". Response categories are measured on a five-point Likert scale ranging from 'not at all' (0) to 'very much' (4). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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