NCT05234281

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

Status unknown NA Last updated 5 July 2022

What this trial tests

NA trial testing Interdisciplincary concentrated group rehabilitation in Mixed Anxiety Depression in 1,000 participants. Status unknown.

Timeline

1 May 2021

Primary endpoint
1 May 2023

1 May 2024

Quick facts

Lead sponsor	Helse i Hardanger
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	1,000
Start date	1 May 2021
Primary completion	1 May 2023
Estimated completion	1 May 2024
Sites	1 location across Norway

Drugs / interventions tested

• Interdisciplincary concentrated group rehabilitation

Conditions studied

• Mixed Anxiety Depression — all drugs for Mixed Anxiety Depression →
• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
• Low Back Pain — all drugs for Low Back Pain →
• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

Helse i Hardanger

Who can join

18 and older, any sex, with Mixed Anxiety Depression or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A safe and effective micro-choice based rehabilitation for patients with long COVID: results from a quasi-experimental study.
   Frisk B, Jürgensen M, Espehaug B, Njøten KL, et al · · 2023 · cited 28× · PMID 37296140 · DOI 10.1038/s41598-023-35991-y
2. Relationship between exercise capacity and fatigue, dyspnea, and lung function in non-hospitalized patients with long COVID.
   Njøten KL, Espehaug B, Magnussen LH, Jürgensen M, et al · · 2023 · cited 10× · PMID 37984816 · DOI 10.14814/phy2.15850
3. 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.
   Kvale G, Søfteland E, Jürgensen M, Wilhelmsen-Langeland A, et al · · 2024 · cited 8× · PMID 38200486 · DOI 10.1186/s12916-023-03237-3
4. Concentrated transdiagnostic and cross-disciplinary group treatment for patients with depression and with anxiety: a pilot study.
   Kvale G, Wilhelmsen-Langeland A, Jürgensen M, Hystad SW, et al · · 2022 · cited 5× · PMID 36058925 · DOI 10.1186/s12888-022-04229-y
5. 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.
   Wilhelmsen-Langeland A, Børtveit T, Jürgensen M, Søfteland E, et al · · 2024 · cited 3× · PMID 38745158 · DOI 10.1186/s12888-024-05786-0
6. A Novel Concentrated, Interdisciplinary Group Rehabilitation Program for Patients With Chronic Obstructive Pulmonary Disease: Protocol for a Nonrandomized Clinical Intervention Study.
   Frisk B, Njøten KL, Aarli B, Hystad SW, et al · · 2022 · cited 2× · PMID 36287602 · DOI 10.2196/40700
7. Improvements in long COVID symptoms, functional level and the impact of illness perceptions after concentrated micro-choice-based rehabilitation: A1-year prospective uncontrolled study.
   Jürgensen M, Frisk B, Kvale G, Espehaug B. · · 2026 · PMID 42061273 · DOI 10.1016/j.jpsychores.2026.112687
8. Exploring experiences following participation in a concentrated micro-choice-based rehabilitation programme for long covid: a focus group study.
   Njøten KL, Magnussen LH, Haugstvedt A, Jürgensen M, et al · · 2026 · PMID 41813046 · DOI 10.1136/bmjopen-2025-105215