Mixed Anxiety DepressionNCT05234281
Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post COVID-19 Fatigue)
A study testing Interdisciplincary concentrated group rehabilitation in people with Mixed Anxiety Depression and Diabetes Mellitus, Type 2, run by Helse i Hardanger at 1 site in Norway.
Trial summary
The health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. Among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Anxiety Depression, Diabetes Mellitus, Type 2, Low Back Pain
- What is being tested?
- Interdisciplincary concentrated group rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 May 2021to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Competent to consent
- Motivated to participate throughout the project
- Digital competence
Who cannot join
- Medical conditions that could preclude proper participation
- Unable to take care of everyday needs (nursing requirements)
- Cognitive failure
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Helse i Hardanger
Øystese, 5610
Eirik Søfteland, PhD, +47 56 12 60 66, eirik.softeland.med@helse-bergen.no
Sissel Børve, +47 56 12 60 66, sissel@helseihardanger.no
About this study
Official title: Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Mixed Anxiety Depression, Diabetes Mellitus Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease and Post COVID-19 Fatigue)
The health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. Among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. Recently, the rise of the Corona pandemic has yielded another group of (primarily young) patients with decreased work capacity, the post-Covid syndrome sufferers.
The aim of the present study is to establish, describe and summarize the experiences with a novel approach to rehabilitation for five of the most costly conditions; 1) low back pain, 2) chronic obstructive pulmonary disease, 3) type 2 diabetes mellitus, 4) mixed anxiety/depression and 5) post-Covid fatigue.
Read more
The concentrated interdisciplinary rehabilitation is characterised by three phases;
- Pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change
- Concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below)
- Post-intervention follow-up (1 year): digital follow-up with the aim of integrate the changes into everyday living
The concentrated intervention:
The core intervention is based on trans-diagnostic features of the highly successful 4-day intervention for Obsessive Compulsive Disorder, namely:
- Initiate treatment when the patient is ready for change
- Focus on the behavioral patterns which maintain the disorder and help the patient to identify situations where they can choose to break the pattern ("micro-choices").
- Assist the patient when they practice breaking the patterns. This may pertain to how they do physical training or to the way they walk, sit, eat, talk, take their medication and sleep, or to how they engage in social activities or take care of others.
- Use long sessions to ensure that they face a broad range of potential micro-choices
- Work side-by side with others going through an analogous pattern of change
- Prepare them for taking responsibility for integrating the change into every-day living
Main outcomes will be
- Completion rates
- Patient satisfaction
- Changes to perception of illness
- Patient activation
Secondary outcomes will be
- Level of functioning
- Qualitative description of participants' experiences
- Conditions
- Mixed Anxiety Depression, Diabetes Mellitus, Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease, COVID-19
- Being tested
- Interdisciplincary concentrated group rehabilitation
- Medical subject headings
- Diabetes Mellitus, Type 2, Low Back Pain, Pulmonary Disease, Chronic Obstructive, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplincary concentrated group rehabilitationOther
All arms receive a concentrated interdisciplinary rehabilitation with similar focus and structure:
Three phases:
- Pre-intervention preparation (1-2 months): mobilize the patients' resources for change
- Concentrated group intervention (2-5 days): (further described below)
- Post-intervention follow-up (1 year): digital follow-up
The core intervention is based on the concentrated rehabilitation format:
- Initiate treatment when the patient is ready for change
- Focus on the behavioral patterns which maintain the disorder, identify situations where they can break the patterns ("micro-choices").
- Assist the patient when breaking the patterns.
- Use long sessions to ensure that they face a broad range of potential micro-choices
- Work side-by side with others going through an analogous pattern of change
- Prepare them for taking responsibility for integrating the change into every-day living
| Study group | Role | What they receive |
|---|---|---|
| Low back pain | Other | Adults with chronic low back pain and at least 4 months of decreased work participation. Intervention as for all groups but with the use of GLADRyg back rehabilitation principles. Receives: Other: Interdisciplincary concentrated group rehabilitation |
| Chronic Obstructive Pulmonary Disease (COPD) | Other | Adults with COPD (FEV1<80%). Intervention as for all groups but with added pulmonary rehabilitation focus. Receives: Other: Interdisciplincary concentrated group rehabilitation |
| Diabetes type 2 | Other | Adults with type 2 diabetes and diabetes-related challenges including dysglycaemia, diabetic complications and/or weight issues. Intervention as for all groups but with added focus on how to make useful microchoices in terms of lifestyle. Receives: Other: Interdisciplincary concentrated group rehabilitation |
| Mixed anxiety/depression | Other | Young adults (18-35 years) with mixed anxiety/depression. Intervention as for all groups but with added focus on "acceptance and commitment therapy", behavioral analysis, metacognitive therapy and physical activity. Receives: Other: Interdisciplincary concentrated group rehabilitation |
| Post COVID-19 | Other | Adults who have persistant fatigue and/or dyspnea following infection with COVID-19. Receives: Other: Interdisciplincary concentrated group rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion rates
Percentage of participants who are eligible for participation, who complete the 1 year programme
Measured: 12 months
Patient satisfaction
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item questionnaire that measures patient satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very high satisfaction). The total score ranges from 8-32, with higher scores indicating higher degree of satisfaction. The CSQ-8 has good psychometric properties, with high internal consistency (Cronbach's α = .93), and high inter-item correlation.
Measured: 1 week post treatment and 12 months
Changes to cognitive and emotional perception of illness
Changes (absolute levels and %) in cognitive and emotional representations of illness before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire The Brief Illness Perception Questionnaire (Brief IPQ). This is a 9-item questionnaire designed to assess cognitive and emotional representations of illness. Questions are graded from 1 to 10. The last item deals with perceived cause of illness, in which respondents list the perceived three most important causal factors in their illness. For this questionnaire, the general word 'illness' can be replaced by the name of a particular illness. The word 'treatment' in the treatment control item can be replaced by a particular treatment such as 'surgery' or 'physiotherapy'.
Measured: Baseline, 3, 6 and 12 months
Changes in level of patient activation
Changes (absolute levels and %) in patient activation before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire Patient Activation Measure (PAM-13). This is the shortened version developed by Hibbard et al in 2005. Each question replied categorically as either disagree strongly, disagree, agree, agree strongly or N/A. These are further scored and summarized, yielding a 0-100 score, where higher score indicates higher degree of patient activation. The questionnaire is widely used, with high internal consistency (Cronbach's α = .91).
Measured: Baseline, 3, 6 and 12 months
Secondary outcomes (1)
Changes in level of functioning
Changes (absolute levels and %) in level of everyday function before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire Work and Social Adjustment Scale (WSAS). This short (6 item) questionnaire allows participants to grade their level of functioning on a 9-point scale, ranging from severly impaired to not impaired. The scale is widely used, and according to studies provide high internal consistencies ranging from Cronbach's α 0.70 to 0.94.
Measured: Baseline, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mixed Anxiety DepressionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Five groups of patients will be enrolled in this project, all in parallell, no randomization
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse i Hardanger
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Eirik Søfteland, PhD, Principal investigator, Helse i Hardanger
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234281
- Sponsor's protocol ID
- 2020/101648
- Status last verified
- Jul 2022
- First submitted
- 26 May 2021
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Njoten KL, Magnussen LH, Haugstvedt A, Jurgensen M, Kvale G, Frisk B. Exploring experiences following participation in a concentrated micro-choice-based rehabilitation programme for long covid: a focus group study. BMJ Open. 2026 Mar 11;16(3):e105215. doi: 10.1136/bmjopen-2025-105215.
PubMed 41813046Borsheim C, Maeland S, Softeland E, Hystad SW, Kvale G, Tunset A, Odegaard-Olsen O, Hartvigsen J, Kadar T. Short-term outcomes of a micro-choice-based intervention for chronic low back pain: a quasi-experimental study. BMC Musculoskelet Disord. 2026 Feb 17;27(1):238. doi: 10.1186/s12891-026-09635-x.
PubMed 41703525Wilhelmsen-Langeland A, Bortveit T, Jurgensen M, Softeland E, Hystad SW, Kvale G. Concentrated transdiagnostic and cross-disciplinary micro-choice based group treatment for patients with depression and with anxiety leads to lasting improvements after 12 months: a pilot study. BMC Psychiatry. 2024 May 14;24(1):361. doi: 10.1186/s12888-024-05786-0.
PubMed 38745158Kvale G, Softeland E, Jurgensen M, Wilhelmsen-Langeland A, Haugstvedt A, Hystad SW, Odegaard-Olsen OT, Aarli BB, Rykken S, Frisk B. First trans-diagnostic experiences with a novel micro-choice based concentrated group rehabilitation for patients with low back pain, long COVID, and type 2 diabetes: a pilot study. BMC Med. 2024 Jan 11;22(1):12. doi: 10.1186/s12916-023-03237-3.
PubMed 38200486Frisk B, Njoten KL, Aarli B, Hystad SW, Rykken S, Kjosas A, Softeland E, Kvale G. A Novel Concentrated, Interdisciplinary Group Rehabilitation Program for Patients With Chronic Obstructive Pulmonary Disease: Protocol for a Nonrandomized Clinical Intervention Study. JMIR Res Protoc. 2022 Oct 26;11(10):e40700. doi: 10.2196/40700.
PubMed 36287602Kvale G, Wilhelmsen-Langeland A, Jurgensen M, Hystad SW, Ost LG, Softeland E, Bortveit T. Concentrated transdiagnostic and cross-disciplinary group treatment for patients with depression and with anxiety: a pilot study. BMC Psychiatry. 2022 Sep 5;22(1):587. doi: 10.1186/s12888-022-04229-y.
PubMed 36058925
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Mixed Anxiety Depression, Diabetes Mellitus Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease and Post COVID-19 Fatigue)
- ClinicalTrials.gov ID
- NCT05234281
- Acronym / sponsor ID
- 2020/101648
- Conditions
- Mixed Anxiety Depression, Diabetes Mellitus, Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Helse i HardangerUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 10 Feb 2022 (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 health care is faced by a growing challenge in the years to come: increasing age and chronic morbidity raising the costs, combined with decreased work participation. Among the conditions on the rise, we find anxiety/depression, musculoskeletal conditions, type 2 diabetes and chronic obstructive pulmonary disease. Recently, the rise of the Corona pandemic has yielded another group of (primarily young) patients with decreased work capacity, the post-Covid syndrome sufferers.
The aim of the present study is to establish, describe and summarize the experiences with a novel approach to rehabilitation for five of the most costly conditions; 1) low back pain, 2) chronic obstructive pulmonary disease, 3) type 2 diabetes mellitus, 4) mixed anxiety/depression and 5) post-Covid fatigue.
The concentrated interdisciplinary rehabilitation is characterised by three phases;
- Pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change
- Concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below)
- Post-intervention follow-up (1 year): digital follow-up with the aim of integrate the changes into everyday living
The concentrated intervention:
The core intervention is based on trans-diagnostic features of the highly successful 4-day intervention for Obsessive Compulsive Disorder, namely:
- Initiate treatment when the patient is ready for change
- Focus on the behavioral patterns which maintain the disorder and help the patient to identify situations where they can choose to break the pattern ("micro-choices").
- Assist the patient when they practice breaking the patterns. This may pertain to how they do physical training or to the way they walk, sit, eat, talk, take their medication and sleep, or to how they engage in social activities or take care of others.
- Use long sessions to ensure that they face a broad range of potential micro-choices
- Work side-by side with others going through an analogous pattern of change
- Prepare them for taking responsibility for integrating the change into every-day living
Main outcomes will be
- Completion rates
- Patient satisfaction
- Changes to perception of illness
- Patient activation
Secondary outcomes will be
- Level of functioning
- Qualitative description of participants' experiences
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Five groups of patients will be enrolled in this project, all in parallell, no randomization
| Arm | Type | Receives |
|---|---|---|
| Low back pain | Other | Other: Interdisciplincary concentrated group rehabilitationAdults with chronic low back pain and at least 4 months of decreased work participation. Intervention as for all groups but with the use of GLADRyg back rehabilitation principles. |
| Chronic Obstructive Pulmonary Disease (COPD) | Other | Other: Interdisciplincary concentrated group rehabilitationAdults with COPD (FEV1<80%). Intervention as for all groups but with added pulmonary rehabilitation focus. |
| Diabetes type 2 | Other | Other: Interdisciplincary concentrated group rehabilitationAdults with type 2 diabetes and diabetes-related challenges including dysglycaemia, diabetic complications and/or weight issues. Intervention as for all groups but with added focus on how to make useful microchoices in terms of lifestyle. |
| Mixed anxiety/depression | Other | Other: Interdisciplincary concentrated group rehabilitationYoung adults (18-35 years) with mixed anxiety/depression. Intervention as for all groups but with added focus on "acceptance and commitment therapy", behavioral analysis, metacognitive therapy and physical activity. |
| Post COVID-19 | Other | Other: Interdisciplincary concentrated group rehabilitationAdults who have persistant fatigue and/or dyspnea following infection with COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Competent to consent
- Motivated to participate throughout the project
- Digital competence
Key exclusion criteria (3 listed)
- Medical conditions that could preclude proper participation
- Unable to take care of everyday needs (nursing requirements)
- Cognitive failure
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 |
|---|---|---|
| Interdisciplincary concentrated group rehabilitationAll arms receive a concentrated interdisciplinary rehabilitation with similar focus and structure: Three phases: 1. Pre-intervention preparation (1-2 months): mobilize the patients' resources for change 2. Concentrated group intervention (2-5 days): (further described below) 3. Post-intervention follow-up (1 year): digital follow-up The core intervention is based on the concentrated rehabilitation format: 1. Initiate treatment when the patient is ready for change 2. Focus on the behavioral patterns which maintain the disorder, identify situations where they can break the patterns ("micro-choices"). 3. Assist the patient when breaking the patterns. 4. Use long sessions to ensure that they face a broad range of potential micro-choices 5. Work side-by side with others going through an analogous pattern of change 6. Prepare them for taking responsibility for integrating the change into every-day living | Other | Chronic Obstructive Pulmonary Disease (COPD), Diabetes type 2, Low back pain, Mixed anxiety/depression, Post COVID-19 |
Primary outcome
Completion rates
Time frame: 12 months
Percentage of participants who are eligible for participation, who complete the 1 year programme
Patient satisfaction
Time frame: 1 week post treatment and 12 months
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item questionnaire that measures patient satisfaction with health services, where the items are rated from 1 (very low satisfaction) to 4 (very high satisfaction). The total score ranges from 8-32, with higher scores indicating higher degree of satisfaction. The CSQ-8 has good psychometric properties, with high internal consistency (Cronbach's α = .93), and high inter-item correlation.
Changes to cognitive and emotional perception of illness
Time frame: Baseline, 3, 6 and 12 months
Changes (absolute levels and %) in cognitive and emotional representations of illness before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire The Brief Illness Perception Questionnaire (Brief IPQ). This is a 9-item questionnaire designed to assess cognitive and emotional representations of illness. Questions are graded from 1 to 10. The last item deals with perceived cause of illness, in which respondents list the perceived three most important causal factors in their illness. For this questionnaire, the general word 'illness' can be replaced by the name of a particular illness. The word 'treatment' in the treatment control item can be replaced by a particular treatment such as 'surgery' or 'physiotherapy'.
Changes in level of patient activation
Time frame: Baseline, 3, 6 and 12 months
Changes (absolute levels and %) in patient activation before, 3, 6 and 12 months after the intervention, as measured through the generic questionnaire Patient Activation Measure (PAM-13). This is the shortened version developed by Hibbard et al in 2005. Each question replied categorically as either disagree strongly, disagree, agree, agree strongly or N/A. These are further scored and summarized, yielding a 0-100 score, where higher score indicates higher degree of patient activation. The questionnaire is widely used, with high internal consistency (Cronbach's α = .91).
1 secondary outcome
Changes in level of functioning
Time frame: Baseline, 3, 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Derived from this study: PubMed 41813046Njoten KL, Magnussen LH, Haugstvedt A, Jurgensen M, Kvale G, Frisk B. Exploring experiences following participation in a concentrated micro-choice-based rehabilitation programme for long covid: a focus group study. BMJ Open. 2026 Mar 11;16(3):e105215. doi: 10.1136/bmjopen-2025-105215.
- Derived from this study: PubMed 41703525Borsheim C, Maeland S, Softeland E, Hystad SW, Kvale G, Tunset A, Odegaard-Olsen O, Hartvigsen J, Kadar T. Short-term outcomes of a micro-choice-based intervention for chronic low back pain: a quasi-experimental study. BMC Musculoskelet Disord. 2026 Feb 17;27(1):238. doi: 10.1186/s12891-026-09635-x.
- Derived from this study: PubMed 38745158Wilhelmsen-Langeland A, Bortveit T, Jurgensen M, Softeland E, Hystad SW, Kvale G. Concentrated transdiagnostic and cross-disciplinary micro-choice based group treatment for patients with depression and with anxiety leads to lasting improvements after 12 months: a pilot study. BMC Psychiatry. 2024 May 14;24(1):361. doi: 10.1186/s12888-024-05786-0.
- Derived from this study: PubMed 38200486Kvale G, Softeland E, Jurgensen M, Wilhelmsen-Langeland A, Haugstvedt A, Hystad SW, Odegaard-Olsen OT, Aarli BB, Rykken S, Frisk B. First trans-diagnostic experiences with a novel micro-choice based concentrated group rehabilitation for patients with low back pain, long COVID, and type 2 diabetes: a pilot study. BMC Med. 2024 Jan 11;22(1):12. doi: 10.1186/s12916-023-03237-3.
- Derived from this study: PubMed 36287602Frisk B, Njoten KL, Aarli B, Hystad SW, Rykken S, Kjosas A, Softeland E, Kvale G. A Novel Concentrated, Interdisciplinary Group Rehabilitation Program for Patients With Chronic Obstructive Pulmonary Disease: Protocol for a Nonrandomized Clinical Intervention Study. JMIR Res Protoc. 2022 Oct 26;11(10):e40700. doi: 10.2196/40700.
- Derived from this study: PubMed 36058925Kvale G, Wilhelmsen-Langeland A, Jurgensen M, Hystad SW, Ost LG, Softeland E, Bortveit T. Concentrated transdiagnostic and cross-disciplinary group treatment for patients with depression and with anxiety: a pilot study. BMC Psychiatry. 2022 Sep 5;22(1):587. doi: 10.1186/s12888-022-04229-y.
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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. This study is not recruiting at the moment.
Eirik Søfteland, PhD principal investigator
Helse i Hardanger
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplincary concentrated group rehabilitation in people with Mixed Anxiety Depression and Diabetes Mellitus, Type 2, run by Helse i Hardanger at 1 site in Norway.
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 3 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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eirik Søfteland, PhD (+47 56 12 60 66, eirik.softeland.med@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion rates (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234281, which also lists 6 linked publications.
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 5 Jul 2022.