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Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post COVID-19 Fatigue)

Primary Purpose

Mixed Anxiety Depression, Diabetes Mellitus, Type 2, Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Interdisciplincary concentrated group rehabilitation
Sponsored by
Helse i Hardanger
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mixed Anxiety Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Competent to consent
  • Motivated to participate throughout the project
  • Digital competence

Exclusion Criteria:

  • Medical conditions that could preclude proper participation
  • Unable to take care of everyday needs (nursing requirements)
  • Cognitive failure

Sites / Locations

  • Helse i HardangerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Other

Other

Other

Other

Other

Arm Label

Low back pain

Chronic Obstructive Pulmonary Disease (COPD)

Diabetes type 2

Mixed anxiety/depression

Post COVID-19

Arm Description

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.

Adults with COPD (FEV1<80%). Intervention as for all groups but with added pulmonary rehabilitation focus.

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.

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.

Adults who have persistant fatigue and/or dyspnea following infection with COVID-19.

Outcomes

Primary Outcome Measures

Completion rates
Percentage of participants who are eligible for participation, who complete the 1 year programme
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.
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'.
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).

Secondary Outcome Measures

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.

Full Information

First Posted
May 26, 2021
Last Updated
July 1, 2022
Sponsor
Helse i Hardanger
Collaborators
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05234281
Brief Title
Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post COVID-19 Fatigue)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse i Hardanger
Collaborators
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Anxiety Depression, Diabetes Mellitus, Type 2, Low Back Pain, Chronic Obstructive Pulmonary Disease, COVID-19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Five groups of patients will be enrolled in this project, all in parallell, no randomization
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low back pain
Arm Type
Other
Arm Description
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.
Arm Title
Chronic Obstructive Pulmonary Disease (COPD)
Arm Type
Other
Arm Description
Adults with COPD (FEV1<80%). Intervention as for all groups but with added pulmonary rehabilitation focus.
Arm Title
Diabetes type 2
Arm Type
Other
Arm Description
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.
Arm Title
Mixed anxiety/depression
Arm Type
Other
Arm Description
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.
Arm Title
Post COVID-19
Arm Type
Other
Arm Description
Adults who have persistant fatigue and/or dyspnea following infection with COVID-19.
Intervention Type
Other
Intervention Name(s)
Interdisciplincary concentrated group rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
Completion rates
Description
Percentage of participants who are eligible for participation, who complete the 1 year programme
Time Frame
12 months
Title
Patient satisfaction
Description
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.
Time Frame
1 week post treatment and 12 months
Title
Changes to cognitive and emotional perception of illness
Description
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'.
Time Frame
Baseline, 3, 6 and 12 months
Title
Changes in level of patient activation
Description
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).
Time Frame
Baseline, 3, 6 and 12 months
Secondary Outcome Measure Information:
Title
Changes in level of functioning
Description
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.
Time Frame
Baseline, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Competent to consent Motivated to participate throughout the project Digital competence Exclusion Criteria: Medical conditions that could preclude proper participation Unable to take care of everyday needs (nursing requirements) Cognitive failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eirik Søfteland, PhD
Phone
+47 56 12 60 66
Email
eirik.softeland.med@helse-bergen.no
First Name & Middle Initial & Last Name or Official Title & Degree
Sissel Børve
Phone
+47 56 12 60 66
Email
sissel@helseihardanger.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eirik Søfteland, PhD
Organizational Affiliation
Helse i Hardanger
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helse i Hardanger
City
Øystese
ZIP/Postal Code
5610
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eirik Søfteland, PhD
Phone
+47 56 12 60 66
Email
eirik.softeland.med@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Sissel Børve
Phone
+47 56 12 60 66
Email
sissel@helseihardanger.no

12. IPD Sharing Statement

Citations:
PubMed Identifier
36287602
Citation
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.
Results Reference
derived
PubMed Identifier
36058925
Citation
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.
Results Reference
derived

Learn more about this trial

Concentrated Cross-disciplinary Group Intervention for Common Health Complaints (Including Post COVID-19 Fatigue)

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