Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post COVID-19 Fatigue)
NCT ID: NCT05234281
Last Updated: 2022-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2021-05-01
2024-05-01
Brief Summary
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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;
1. Pre-intervention preparation (1-2 months): with the aim to mobilize the patients' resources for change
2. Concentrated group intervention (2-5 days): interdisciplinary team - individually tailored training (further described below)
3. 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
1. Completion rates
2. Patient satisfaction
3. Changes to perception of illness
4. Patient activation
Secondary outcomes will be
1. Level of functioning
2. Qualitative description of participants' experiences
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Low back pain
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.
Interdisciplincary concentrated group rehabilitation
All 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
Chronic Obstructive Pulmonary Disease (COPD)
Adults with COPD (FEV1\<80%). Intervention as for all groups but with added pulmonary rehabilitation focus.
Interdisciplincary concentrated group rehabilitation
All 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
Diabetes type 2
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.
Interdisciplincary concentrated group rehabilitation
All 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
Mixed anxiety/depression
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.
Interdisciplincary concentrated group rehabilitation
All 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
Post COVID-19
Adults who have persistant fatigue and/or dyspnea following infection with COVID-19.
Interdisciplincary concentrated group rehabilitation
All 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
Interventions
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Interdisciplincary concentrated group rehabilitation
All 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
Eligibility Criteria
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Inclusion Criteria
* Motivated to participate throughout the project
* Digital competence
Exclusion Criteria
* Unable to take care of everyday needs (nursing requirements)
* Cognitive failure
18 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Helse i Hardanger
OTHER
Responsible Party
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Principal Investigators
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Eirik Søfteland, PhD
Role: PRINCIPAL_INVESTIGATOR
Helse i Hardanger
Locations
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Helse i Hardanger
Øystese, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Wilhelmsen-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.
Kvale 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.
Frisk 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.
Kvale 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020/101648
Identifier Type: -
Identifier Source: org_study_id
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