Clinical trial NCT03888261: Mind-Body Approaches for Medical Conditions
Official title: Effectiveness of Mind-Body Approaches for Three Distinct Medical Conditions: A Pragmatic Randomized Controlled Television Broadcast Experiment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Psoriasis
Heart Failure
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
name: Department of psychology, University of Copenhagen
name: Musculoskeletal Statistics Unit, The Parker Institute
First posted: 2019-03-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic diseases are currently the most prevalent and most costly health conditions world-wide, and morbidity is expected to increase over coming years. Factors such that increased life-expectancy and certain life style-related factors, such as smoking, high-fat diet and alcohol-consumption, are commonly associated with the increase in most of the common chronic diseases. However, more complex psychosocial factors such as depression, stress, work-related dynamics and thinking patterns are thought be associated with poor health status and impaired health related quality of life among patients with suffering from chronic physical conditions (i.e. a biopsychosocial approach). Therefore, psychosocial intervention has been suggested as a complementary treatment strategy for patients with chronic conditions.

The aim of this randomized trial is to evaluate the effectiveness of mind-body multidisciplinary rehabilitation on health-related quality of life, and disease specific endpoints in people with rheumatoid arthritis, psoriasis, or heart failure.


Eligibility criteria: Inclusion Criteria:

Rheumatoid arthritis:

* RA according to the 1987 revised American College of Rheumatology criteria
* Not selected on the basis of their level of activity.
* The treatment of both the RA and any other medical condition have to be stable and constant for at least three months at the time of enrolment, and no future planned changes of therapy exist at the time of inclusion.
* Oral corticosteroids, if used previously, will be allowed at a maximum prednisone dose with an equivalent of 10mg/day.

Psoriasis:

* Diagnosed plaque psoriasis for 6 months or longer
* Psoriasis medical condition have to be stable and constant for at least three months at the time of enrolment (i.e. no future planned changes of therapy exist at the time of inclusion).
* Exclusion criteria are other immune-mediated conditions requiring current systemic immunosuppressant treatment except psoriatic arthritis.

Heart Failure with reduced ejection fraction:

* Symptomatic patients (NYHA class II or III, or NYHA class IV if CRT planned at enrolment) with systolic heart failure (left ventricular ejection fraction ≤40%) will be considered eligible for enrolment.
* The qualifying left ventricular ejection fraction (measured on stable heart failure medication).

Exclusion Criteria:

* Ability to participate
* Psychopathology: Persons with severe mental illness are excluded.
* Alcohol and/ or drug abuse
* Impaired cognitive functions

Primary outcomes:
measure: WHO-Five Well-being Index
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Secondary outcomes:
measure: SF36: Physical Component Summary (PCS)
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: SF36: Mental Component Summary (MCS)
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Illness Perception Questionnaire
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Pittsburgh sleep quality index
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: High-sensitivity C-reactive protein (hs-CRP)
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Mindful Attention Awareness Scale-5
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Self-Compassion Scale
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Cohen's Perceived Stress Scale
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Hospital anxiety and depression scale (HADS)
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Other outcomes:
measure: Disease activity score 28 based on C-reactive protein (DAS28-CRP)
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Tender joints
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Swollen joints
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: VAS-Pain
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: VAS-Patient global assessment
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Psoriasis Area and Severity Index
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Physician Global Assessment (PGA)
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Dermatology Life Quality Index (DLQI)
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
measure: Kansas City Cardiomyopathy Questionnaire
timeFrame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Locations:
Study officials:
References: