Trial · NCT07912515
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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). |
| Secondary | Use of health care services | Baseline (first login in programme), 3-months after End of Treatment | Twelve individual items will be used to assess participants' use of healthcare services and medication consumption over the past three months. Eight items refer to the number of consultations participants have had with various healthcare professionals, including general practitioners, social workers, manual therapists, occupational therapists, dietitians, alternative practitioners, psychologists, psychotherapists, or psychiatrists, and private specialist doctors. Participants can either indicate that they have had no consultations at all or specify the number of visits. Additionally, three items assess whether participants have visited an emergency department, had outpatient consultations, or been hospitalized. The response categories are the same as in the previous section. Finally, one item evaluates medication consumption. Participants will be asked whether they have taken painkillers, medication for anxiety or depression, diuretics, weight-loss medication, or protein supplements. |
| Other | Participant expectancy | Baseline (first login in programme) | To measure the young person's credibility and expectancy before the self-help intervention start, two ad hoc items has been developed inspired by the Credibility and Expectancy Questionnaire. These two items are: "1) How meaningful does this self-help programme offered to you seem?" and "2) How efficient do you think this self-help programme will be in reducing your symptoms?" A scale ranging from 'not meaningful at all'/not efficient at all' (1) to 'highly meaningful'/'highly efficient' (10) will be provided. |
| Other | Program evaluation | End of Treatment (8 weeks after baseline) | Participants will be asked to evaluate the My Symptoms Young programme with regard to ease of use (one item), overall benefit from the programme (one item), each of its seven modules (7 items) and the four main tools that support participant activity and monitoring throughout the programme: the goal ladder, the don't break the chain, the symptom registration tool and the notebook (4 items). All items are scored on a five-point Likert-type scale representing the extent to which the young person find the programme easy to use or has experienced benefit. The scale ranges from 'not at all' (0) to 'to a very great extent' (4). Finally, the young person is asked to indicate on a VAS scale (0-10), whether they would recommend the treatment programme to a friend with similar problems. |
| Other | Brief Health Literacy Scale for Adults (B-HLA) | Baseline (first login in programme) | To measure participants' overall health literacy, we will use the Brief Health Literacy Scale for Adults (B-HLA). B-HLA is a validated tool for adults developed based on the HLSAC questionnaire, which is a widely used and validated instrument for assessing health literacy in children. The B-HLA consists of 10 questions covering five theoretical components of health literacy: knowledge, practical knowledge, critical thinking, self-awareness, and community engagement. The tool was translated and validated for the Danish context in 2023. Responses are rated on a four-point scale: Not at all true, not quite true, somewhat true, and completely true. The total score ranges from 10 to 40 points and can be categorized into three levels of health literacy: low (10-25), moderate (26-35), and high (36-40). |
| Other | The eHealth Literacy Questionnaire (eHLQ) | Baseline (first login in programme) | To assess the extent to which participants feel motivated to use digital tools for managing their health, the investigators will use a scale from the eHealth Literacy Questionnaire (eHLQ). The eHLQ consists of seven scales with a total of 35 items and is used to map experiences related to finding, understanding, and using digital health information, managing one's own health, and communicating with healthcare professionals. The investigators will use only scale 5, "Motivated to engage with digital services," which includes five items. Responses are rated on a four-point scale: strongly disagree, disagree, agree, and strongly agree. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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