Persistent Physical SymptomseASYNCT06163014
My Symptoms: an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care
An observational study of Persistent Physical Symptoms, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.mine-symptomer.dk. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Persistent Physical Symptoms
- What is being tested?
- My Symptoms eHealth programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Only patients who consult their GP will be eligible for participation. Patients will need a referral from their GP to be able to access the 'My Symptoms' programme using a specific code. All patients who consent to participate and login to the programme will be included in the present study. The GP will assess whether prescription of the 'My Symptoms' programme is relevant. As a guide for this assessment, the GP will be provided with the inclusion and exclusion criteria during their training programme.
Who may be able to join
- Age 18-65 (target population for the programme)
- The consultation targets symptom complaints
- Listed with participating practice.
Who cannot join
- Symptoms are acute (not persistent) and there is no need for this intervention
- Symptoms must primarily be treated by medicine or surgery
- Patient severely affected by other disease
- Not eligible due to language or cognitive problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lisbeth Frostholm, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Marianne Rosendal, MD, PhD, 004520411619, marose@rm.dk
About this study
Official title: My Symptoms: a Before-After Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care (eASY)
The project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.mine-symptomer.dk.
The research programme is an ambitious and dedicated effort aiming at improvement of functioning and quality of life for individuals with persistent physical symptoms (PPS) and prevention of the development of chronic functional disorders and associated loss of working capacity and high use of health care. At present, access to specialized treatment of PPS is very limited and treatment capacity in general practice is restricted to brief consultations - often with poor opportunity to make a treatment plan for symptoms. As part of the research programme, the investigators have developed a web-based self-help programme for patient with PPS. This treatment programme is prescribed by the patient's general practitioner (GP). Only GPs who have participated in a short introduction course will be allowed for prescriptions.
Read more
The investigators have applied a high degree of user involvement (GPs and patients) in the development process but there is a need to evaluate how the new treatment programme is in fact adopted by GPs and patients.
With this study, the investigators wish to follow the national implementation using a before-after study design describing uptake and effects on GPs, patients and the health care system.
Read the detailed description
The project aims to evaluate the uptake and effects of the new self-help programme for PPS, the My Symptoms programme, prescribed and followed up by GPs.
Specific objectives are to:
- Describe the use of the programme during routine care. This includes
- Determination of the number of patients per GP who access the programme after prescription from their GPs (adoption)
- A description of how often the follow-up consultation is completed according to the patients.
- Explore patient characteristics (appropriateness)
- Describe patients' engagement with the programme with regard to time and frequency of access to modules and tools (fidelity)
- Evaluate effects on patients' health, quality of life, functioning and satisfaction with care
- Estimate effects on patients' use of health care services
- Estimate effects on patients' work productivity
- Estimate possible effects on health care costs provided the intervention is fully disseminated nationally.
- Conditions
- Persistent Physical Symptoms
- Being tested
- My Symptoms eHealth programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Symptoms eHealth programmeBehavioural
My Symptoms supports patients' self-efficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. The patient is free to choose relevant tasks corresponding to wishes, needs/requirements and own perspectives.
Summary of content:
- Symptom explanations and facts about frequent symptoms including brief animated explanations
- Physical energy (sleep, diet and activity)
- Working with resources and strain in everyday life
- Values and choices (meaning and existential issues)
- Thoughts
- Feelings (emotion regulation)
- Self-care (attention incl. mindfulness and audio exercises)
- Preparation for a follow-up visit with the GP and relapse prevention. The above modules connect to four general tools: symptom registration, 'don't break the chain', goal setting staircase and notebook.
After 6 weeks: Voluntary GP follow-up consultation. After 8 weeks: End-of-treatment.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with persistent physical symptoms consulting their GP and referred to the My Symptoms eHealth programme. Receives: Behavioral: My Symptoms eHealth programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptom intensity
Symptom intensity measured by a numeric rating scale (0-10)
Measured: Baseline to end of treatment (week 8)
Change in symptom interference
Symptom interference measured by a numeric rating scale (0-10)
Measured: Baseline to end of treatment (week 8)
Secondary outcomes (48)
Change in symptom intensity
Symptom intensity measured by a numeric rating scale (0-10)
Measured: Baseline to 3 months after end of treatment
Change in symptom interference
Symptom interference measured by a numeric rating scale (0-10)
Measured: Baseline to 3 months after end of treatment
Change in symptom burden
Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100)
Measured: Baseline to end of treatment (week 8)
Change in symptom burden
Bodily Distress Syndrome (BDS) Checklist measuring symptom burden (0-100)
Measured: Baseline to 3 months after end of treatment
Bodily Distress Syndrome
Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)
Measured: Baseline
Bodily Distress Syndrome
Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)
Measured: End of treatment (week 8)
Bodily Distress Syndrome
Bodily Distress Syndrome (BDS) Checklist measuring BDS (0/1)
Measured: 3 months after end of treatment
Change in illness perception
Brief Illness Perception Questionnaire (B-IPQ). Sum score (min 0; max 70). Lower scores indicate more positive illness perceptions.
Measured: Baseline to end of treatment (week 8)
Change in illness perception
Brief Illness Perception Questionnaire (B-IPQ). Sum score (min 0; max 70). Lower scores indicate more positive illness perceptions.
Measured: Baseline to 3 months after end of treatment
Change in illness worry
The revised version of the six-item Whiteley Index (WI-6-R). Sum score (min 0; max 24). Higher scores indicate higher illness worry.
Measured: Baseline to end of treatment (week 8)
Change in illness worry
The revised version of the six-item Whiteley Index (WI-6-R). Sum score (min 0; max 24). Higher scores indicate higher illness worry.
Measured: Baseline to 3 months after end of treatment
Anxiety
Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment.
Measured: Baseline
Anxiety
Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety.
Measured: End of treatment (week 8)
Anxiety
Symptom Checklist Anxiety (SCL-ANX4). Sum score (min 0; max 16). Higher scores indicate higher impairment by anxiety.
Measured: 3 months after end of treatment
Depression
Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.
Measured: Baseline
Depression
Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.
Measured: End of treatment (week 8)
Depression
Symptom Checklist Depression (SCL-DEP6). Sum score (min 0; max 24). Higher scores indicate higher impairment by depression.
Measured: 3 months after end of treatment
Distress
Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.
Measured: Baseline
Distress
Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.
Measured: End of treatment (week 8)
Distress
Symptom Checklist Distress (SCL-Distress8). Sum score (min 0; max 32). Higher scores indicate higher impairment by distress.
Measured: 3 months after end of treatment
Change of hope
One item from the Symptom Checklist (SCL)-90. Response categories ranging from 'not at all' (0) to 'very much' (4) (min 0; max 4). Higher scores indicate higher impairment by hopelessness.
Measured: Baseline to end of treatment (week 8)
Change of hope
One item from the Symptom Checklist (SCL)-90. Response categories ranging from 'not at all' (0) to 'very much' (4) (min 0; max 4). Higher scores indicate higher impairment by hopelessness.
Measured: Baseline to 3 months after end of treatment
Change in stress
Perceived Stress Scale 10-item version (PSS-10). Sum score (min 0; max 40). Higher scores indicate higher stress levels.
Measured: Baseline to end of treatment (week 8)
Change in stress
Perceived Stress Scale 10-item version (PSS-10). Sum score (min 0; max 40). Higher scores indicate higher stress levels.
Measured: Baseline to 3 months after end of treatment
Change in limiting behaviour
Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 24). Lower scores indicate a more adaptive symptom behaviour.
Measured: Baseline to end of treatment (week 8)
Change in limiting behaviour
Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 24). Lower scores indicate a more adaptive symptom behaviour.
Measured: Baseline to 3 months after end of treatment
Change in all or nothing behaviour
Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 28). Lower scores indicate a more adaptive symptom behaviour.
Measured: Baseline to end of treatment (week 8)
Change in all or nothing behaviour
Behaviour Related to Illness Questionnaire (BRIQ), subscale. Sum score (min 0; max 28). Lower scores indicate a more adaptive symptom behaviour.
Measured: Baseline to 3 months after end of treatment
Change in confidence in performing activities in the context of PPS
Adapted version of the Pain Self-Efficacy Questionnaire (PSEQ). Sum score (min 0; max 60). Higher scores indicate better self-efficacy.
Measured: Baseline to end of treatment (week 8)
Change in confidence in performing activities in the context of PPS
Adapted version of the Pain Self-Efficacy Questionnaire (PSEQ). Sum score (min 0; max 60). Higher scores indicate better self-efficacy.
Measured: Baseline to 3 months after end of treatment
Change in health-related quality of life
36-Item Short Form Health Survey (SF-36) (subscales and the physical (PCS) and mental (MCS) component summary scores). PCS and MCS will be transformed into scales ranging from 0 to 100 by the following expression: (patient raw score-lowest possible score)/(highest possible score-lowest possible score)×100. Higher scores express better health.
Measured: Baseline to end of treatment (week 8)
Change in health-related quality of life
36-Item Short Form Health Survey (SF-36) (subscales and the physical (PCS) and mental (MCS) component summary scores). PCS and MCS will be transformed into scales ranging from 0 to 100 by the following expression: (patient raw score-lowest possible score)/(highest possible score-lowest possible score)×100. Higher scores express better health.
Measured: Baseline to 3 months after end of treatment
Health-related quality of life
The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.
Measured: Baseline
Health-related quality of life
The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.
Measured: End of treatment (week 8)
Health-related quality of life
The EuroQoL 5-domain 5-level (EQ-5D-5L). EQ-5D-5L health states will be summarised by a single summary number (index value), which reflects how good or bad the health state is according to the preferences of the general population. Index values will be derived according to the EuroQol Research Foundation manual for EQ-5D-5L.
Measured: 3 months after end of treatment
Credibility related to the eHealth programme
One item measuring credibility. A scale ranging from 'not meaningful at all' (1) to 'highly meaningful' (10) is provided.
Measured: Baseline
Expectancy related to the eHealth programme
One item measuring expectancy. A scale ranging from 'not efficient at all' (1) to 'highly efficient' (10) is provided.
Measured: Baseline
Evaluation of the referral consultation
Questionnaire comprising 6 items. The items are scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5).
Measured: Baseline
Evaluation of the eHealth programme
Questionnaire comprising 12 items. The items are scored on a five-point Likert-type scale representing the extent to which the patient 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).
Measured: End of treatment (week 8)
Recommendation of the eHealth programme
One item. The patient is asked to indicate whether he or she would recommend the treatment programme to a friend with similar problems. A VAS scale (0 ('not at all') - 10 ('highly recommend') is provided.
Measured: End of treatment (week 8)
Evaluation of the follow up consultation
One item measuring satisfaction. The item is scored on a five-point Likert-type scale ranging from 'bad' (1) to 'excellent' (5).
Measured: End of treatment (week 8)
Self-rated global health change
Patient Global Impression of Change (PGIC) scale. One item scored on a five point Likert-type scale ranging from 'Much worse' (1) to 'Much better' health (5).
Measured: End of treatment (week 8)
Self-rated global health change
Patient Global Impression of Change (PGIC) scale. One item scored on a five point Likert-type scale ranging from 'Much worse' (1) to 'Much better' health (5).
Measured: 3 months after end of treatment
Adverse events
Dichotomous outcome measure (0/1). Defined as a 50% worsening of symptoms as measured by the numeric rating scale (NRS) for symptom intensity
Measured: End of treatment (week 8)
Adverse events
Dichotomous outcome measure (0/1). Defined as a 50% worsening of symptoms as measured by the numeric rating scale (NRS) for symptom intensity
Measured: 3 months after end of treatment
Quality-adjusted life year (QALY)
QALY is a single reported value based on the change in patient's health-related quality of life measured with the EuroQoL 5-domain 5-level (EQ-5D-5L) and valued using Danish QALY-weights.
Measured: 6 months after end of treatment
Changes in health care use
Estimation of effects on patients' changes in use of health care services using Danish registers from a before-vs-after approach
Measured: 6 months before baseline compared to 6 months after end of treatment
Changes in productivity costs
Changes in productivity costs i.e., the change in lost production due to changes in sick leaves and absence from work
Measured: 6 months before baseline compared to 6 months after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start1 Dec 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Physical SymptomsStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianne Rosendal, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163014
- Sponsor's protocol ID
- 1-10-72-222-22
- Acronym
- eASY
- Status last verified
- Feb 2025
- First submitted
- 8 Jun 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My Symptoms: a Before-After Evaluation of an eHealth and GP Assisted Programme for Persistent Symptoms in Primary Care (eASY)
- ClinicalTrials.gov ID
- NCT06163014
- Acronym / sponsor ID
- eASY / 1-10-72-222-22
- Conditions
- Persistent Physical Symptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Dec 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 project 'My Symptoms' is part of a large research programme: eHealth and GP-assisted self-help interventions for persistent physical symptoms (eASY). See www.mine-symptomer.dk.
The research programme is an ambitious and dedicated effort aiming at improvement of functioning and quality of life for individuals with persistent physical symptoms (PPS) and prevention of the development of chronic functional disorders and associated loss of working capacity and high use of health care. At present, access to specialized treatment of PPS is very limited and treatment capacity in general practice is restricted to brief consultations - often with poor opportunity to make a treatment plan for symptoms. As part of the research programme, the investigators have developed a web-based self-help programme for patient with PPS. This treatment programme is prescribed by the patient's general practitioner (GP). Only GPs who have participated in a short introduction course will be allowed for prescriptions.
The investigators have applied a high degree of user involvement (GPs and patients) in the development process but there is a need to evaluate how the new treatment programme is in fact adopted by GPs and patients.
With this study, the investigators wish to follow the national implementation using a before-after study design describing uptake and effects on GPs, patients and the health care system.
Detailed description
The project aims to evaluate the uptake and effects of the new self-help programme for PPS, the My Symptoms programme, prescribed and followed up by GPs.
Specific objectives are to:
- Describe the use of the programme during routine care. This includes
- Determination of the number of patients per GP who access the programme after prescription from their GPs (adoption)
- A description of how often the follow-up consultation is completed according to the patients.
- Explore patient characteristics (appropriateness)
- Describe patients' engagement with the programme with regard to time and frequency of access to modules and tools (fidelity)
- Evaluate effects on patients' health, quality of life, functioning and satisfaction with care
- Estimate effects on patients' use of health care services
- Estimate effects on patients' work productivity
- Estimate possible effects on health care costs provided the intervention is fully disseminated nationally.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: My Symptoms eHealth programmePatients with persistent physical symptoms consulting their GP and referred to the My Symptoms eHealth programme. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Only patients who consult their GP will be eligible for participation. Patients will need a referral from their GP to be able to access the 'My Symptoms' programme using a specific code. All patients who consent to participate and login to the programme will be included in the present study. The GP will assess whether prescription of the 'My Symptoms' programme is relevant. As a guide for this assessment, the GP will be provided with the inclusion and exclusion criteria during their training programme.
Key inclusion criteria (3 listed)
- Age 18-65 (target population for the programme)
- The consultation targets symptom complaints
- Listed with participating practice.
Key exclusion criteria (4 listed)
- Symptoms are acute (not persistent) and there is no need for this intervention
- Symptoms must primarily be treated by medicine or surgery
- Patient severely affected by other disease
- Not eligible due to language or cognitive problems
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 |
|---|---|---|
| My Symptoms eHealth programmeMy Symptoms supports patients' self-efficacy and behavioural changes. The programme is activated by the patient after prescription by the GP. The patient is free to choose relevant tasks corresponding to wishes, needs/requirements and own perspectives. Summary of content: 1. Symptom explanations and facts about frequent symptoms including brief animated explanations 2. Physical energy (sleep, diet and activity) 3. Working with resources and strain in everyday life 4. Values and choices (meaning and existential issues) 5. Thoughts 6. Feelings (emotion regulation) 7. Self-care (attention incl. mindfulness and audio exercises) 8. Preparation for a follow-up visit with the GP and relapse prevention. The above modules connect to four general tools: symptom registration, 'don't break the chain', goal setting staircase and notebook. After 6 weeks: Voluntary GP follow-up consultation. After 8 weeks: End-of-treatment. | Behavioural | Patients |
Primary outcome
Change in symptom intensity
Time frame: Baseline to end of treatment (week 8)
Symptom intensity measured by a numeric rating scale (0-10)
Change in symptom interference
Time frame: Baseline to end of treatment (week 8)
Symptom interference measured by a numeric rating scale (0-10)
48 secondary outcomes
Change in symptom intensity
Time frame: Baseline to 3 months after end of treatment
Change in symptom interference
Time frame: Baseline to 3 months after end of treatment
Change in symptom burden
Time frame: Baseline to end of treatment (week 8)
Change in symptom burden
Time frame: Baseline to 3 months after end of treatment
Bodily Distress Syndrome
Time frame: Baseline
Bodily Distress Syndrome
Time frame: End of treatment (week 8)
Bodily Distress Syndrome
Time frame: 3 months after end of treatment
Change in illness perception
Time frame: Baseline to end of treatment (week 8)
Change in illness perception
Time frame: Baseline to 3 months after end of treatment
Change in illness worry
Time frame: Baseline to end of treatment (week 8)
Change in illness worry
Time frame: Baseline to 3 months after end of treatment
Anxiety
Time frame: Baseline
Anxiety
Time frame: End of treatment (week 8)
Anxiety
Time frame: 3 months after end of treatment
Depression
Time frame: Baseline
Depression
Time frame: End of treatment (week 8)
Depression
Time frame: 3 months after end of treatment
Distress
Time frame: Baseline
Distress
Time frame: End of treatment (week 8)
Distress
Time frame: 3 months after end of treatment
Change of hope
Time frame: Baseline to end of treatment (week 8)
Change of hope
Time frame: Baseline to 3 months after end of treatment
Change in stress
Time frame: Baseline to end of treatment (week 8)
Change in stress
Time frame: Baseline to 3 months after end of treatment
Change in limiting behaviour
Time frame: Baseline to end of treatment (week 8)
Change in limiting behaviour
Time frame: Baseline to 3 months after end of treatment
Change in all or nothing behaviour
Time frame: Baseline to end of treatment (week 8)
Change in all or nothing behaviour
Time frame: Baseline to 3 months after end of treatment
Change in confidence in performing activities in the context of PPS
Time frame: Baseline to end of treatment (week 8)
Change in confidence in performing activities in the context of PPS
Time frame: Baseline to 3 months after end of treatment
Change in health-related quality of life
Time frame: Baseline to end of treatment (week 8)
Change in health-related quality of life
Time frame: Baseline to 3 months after end of treatment
Health-related quality of life
Time frame: Baseline
Health-related quality of life
Time frame: End of treatment (week 8)
Health-related quality of life
Time frame: 3 months after end of treatment
Credibility related to the eHealth programme
Time frame: Baseline
Expectancy related to the eHealth programme
Time frame: Baseline
Evaluation of the referral consultation
Time frame: Baseline
Evaluation of the eHealth programme
Time frame: End of treatment (week 8)
Recommendation of the eHealth programme
Time frame: End of treatment (week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Project websiteLink provided by the sponsor.
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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.
Lisbeth Frostholm, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Physical Symptoms, run by Aarhus University Hospital at 1 site in Denmark.
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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 13 Feb 2025. 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 Denmark. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marianne Rosendal, PhD (+4521476826, marose@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptom intensity (time frame: Baseline to end of treatment (week 8)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2025.