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

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05234281
Enrollment
1000
Registered
2022-02-10
Start date
2021-05-01
Completion date
2024-05-01
Last updated
2022-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

OTHERInterdisciplincary 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

Sponsors

Haukeland University Hospital
CollaboratorOTHER
Helse i Hardanger
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Five groups of patients will be enrolled in this project, all in parallell, no randomization

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Completion rates12 monthsPercentage of participants who are eligible for participation, who complete the 1 year programme
Patient satisfaction1 week post treatment and 12 monthsThe 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 illnessBaseline, 3, 6 and 12 monthsChanges (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 activationBaseline, 3, 6 and 12 monthsChanges (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

MeasureTime frameDescription
Changes in level of functioningBaseline, 3, 6 and 12 monthsChanges (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.

Countries

Norway

Contacts

Primary ContactEirik Søfteland, PhD
eirik.softeland.med@helse-bergen.no+47 56 12 60 66
Backup ContactSissel Børve
sissel@helseihardanger.no+47 56 12 60 66

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026