Mind-Body Approaches for Medical Conditions

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Mind-Body Approaches for Three Distinct Medical Conditions: A Pragmatic Randomized Controlled Television Broadcast Experiment

Conditions
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Rheumatoid Arthritis, Psoriasis, Heart Failure

Intervention / Treatment
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* Behavioral: Mind-Body Approaches for Medical Conditions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Intervention:<br>Mind-body intervention (incl. Relaxation Response Resiliency Program & the Open and Calm Program) | Behavioral: Mind-Body Approaches for Medical Conditions<br>* The intervention programme of the present trial is delivered in a group-based format (15 participants per group) and overall applies three therapeutic components: Contemplative practices Psychoeducation Dialogue, including therapist-group dialogue as well as participant-participant dialogue.<br>|
| No Intervention: No Intervention<br>No intervention (Study participants will receive routine clinical practice) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO-Five Well-being Index | All participants. The WHO-5 consists of five statements. The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF36: Physical Component Summary (PCS) | All participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 
| SF36: Mental Component Summary (MCS) | All participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 
| Illness Perception Questionnaire | All participants. Every item is rated using a 0-10 response scale, a higher score reflecting a more threatening view of the illness. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 
| Pittsburgh sleep quality index | All participants. The measure consists of 19 individual items, creating 7 components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 
| High-sensitivity C-reactive protein (hs-CRP) | All participants. Blood sample | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 
| Mindful Attention Awareness Scale-5 | All participants. To score the scale, simply compute a mean of the 15 items. Higher scores reflect higher levels of dispositional mindfulness | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 
| Self-Compassion Scale | All participants. As a rough guide, a score of 1-2.5 for your overall self-compassion score indicates you are low in self-compassion, 2.5-3.5 indicates you are moderate, and 3.5-5.0 means you are high. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 
| Cohen's Perceived Stress Scale | All participants. ► Scores ranging from 0-13 would be considered low stress. ► Scores ranging from 14-26 would be considered moderate stress. ► Scores ranging from 27-40 would be considered high perceived stress | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline | 
| Hospital anxiety and depression scale (HADS) | All participants. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. Higher score indicates worse depression or anxiety. | At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline |