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

Helse i Hardanger

Status: Enrolling

Conditions: COVID-19; Chronic Obstructive Pulmonary Disease; Diabetes Mellitus, Type 2; Mixed Anxiety Depression; Low Back Pain

Treatments: Other: Interdisciplincary concentrated group rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05234281

2020/101648

Details and patient eligibility

About

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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 5 patient groups

Low back pain

Other group

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.

Treatment:

Other: Interdisciplincary concentrated group rehabilitation

Chronic Obstructive Pulmonary Disease (COPD)

Other group

Description:

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

Treatment:

Other: Interdisciplincary concentrated group rehabilitation

Diabetes type 2

Other group

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.

Treatment:

Other: Interdisciplincary concentrated group rehabilitation

Mixed anxiety/depression

Other group

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.

Treatment:

Other: Interdisciplincary concentrated group rehabilitation

Post COVID-19

Other group

Description:

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

Treatment:

Other: Interdisciplincary concentrated group rehabilitation