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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
90
The intervention programme of the present trial is delivered in a group-based format (15 participants per group) and overall applies three therapeutic components: 1. Contemplative practices 2. Psychoeducation 3. Dialogue, including therapist-group dialogue as well as participant-participant dialogue.
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.
Time frame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
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