Clinical trial NCT05234281: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Mixed Anxiety Depression
Diabetes Mellitus, Type 2
Low Back Pain
Chronic Obstructive Pulmonary Disease
COVID-19
Lead sponsor: Helse i Hardanger
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
First posted: 2022-02-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Five groups of patients will be enrolled in this project, all in parallell, no randomization
Primary purpose: OTHER

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;

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


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

Primary outcomes:
measure: Completion rates
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 1 week post treatment and 12 months
measure: Changes to cognitive and emotional perception of illness
timeFrame: Baseline, 3, 6 and 12 months
measure: Changes in level of patient activation
timeFrame: Baseline, 3, 6 and 12 months
Secondary outcomes:
measure: Changes in level of functioning
timeFrame: Baseline, 3, 6 and 12 months
Other outcomes:
Locations:
city: Øystese
country: Norway
facility: Helse i Hardanger
Study officials:
affiliation: Helse i Hardanger
name: Eirik Søfteland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.