Back to resultsMind-Body Approaches for Medical Conditions
Primary Purpose
Rheumatoid Arthritis, Psoriasis, Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mind-Body Approaches for Medical Conditions
Sponsored by
About this trial
This is an interventional supportive care trial for Rheumatoid Arthritis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Active Intervention:
No Intervention
Arm Description
Mind-body intervention (incl. Relaxation Response Resiliency Program & the Open and Calm Program)
No intervention (Study participants will receive routine clinical practice)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
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.
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.
High-sensitivity C-reactive protein (hs-CRP)
All participants. Blood sample
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
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.
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
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.
Full Information
NCT ID
NCT03888261
First Posted
March 11, 2019
Last Updated
March 22, 2019
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Aarhus University Hospital, Odense University Hospital, Department of psychology, University of Copenhagen, Musculoskeletal Statistics Unit, The Parker Institute
1. Study Identification
Unique Protocol Identification Number
NCT03888261
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Aarhus University Hospital, Odense University Hospital, Department of psychology, University of Copenhagen, Musculoskeletal Statistics Unit, The Parker Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Psoriasis, Heart Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Intervention:
Arm Type
Active Comparator
Arm Description
Mind-body intervention (incl. Relaxation Response Resiliency Program & the Open and Calm Program)
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No intervention (Study participants will receive routine clinical practice)
Intervention Type
Behavioral
Intervention Name(s)
Mind-Body Approaches for Medical Conditions
Intervention Description
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.
Primary Outcome Measure Information:
Title
WHO-Five Well-being Index
Description
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
Secondary Outcome Measure Information:
Title
SF36: Physical Component Summary (PCS)
Description
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
Title
SF36: Mental Component Summary (MCS)
Description
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
Title
Illness Perception Questionnaire
Description
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
Title
Pittsburgh sleep quality index
Description
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
Title
High-sensitivity C-reactive protein (hs-CRP)
Description
All participants. Blood sample
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
Mindful Attention Awareness Scale-5
Description
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
Title
Self-Compassion Scale
Description
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
Title
Cohen's Perceived Stress Scale
Description
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
Title
Hospital anxiety and depression scale (HADS)
Description
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
Other Pre-specified Outcome Measures:
Title
Disease activity score 28 based on C-reactive protein (DAS28-CRP)
Description
Rheumatoid Arthritis.
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
Tender joints
Description
Rheumatoid Arthritis.28 joints palpates with a 4 kg pressure. The patient state the perception on pain on a scale from 1-10 cm. A higher score indicates higher pain.
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
Swollen joints
Description
Rheumatoid Arthritis. Assessed by a train physician.
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
VAS-Pain
Description
Rheumatoid Arthritis. Score range from 1-100. Higher score indicates worse pain.
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
VAS-Patient global assessment
Description
Rheumatoid Arthritis. using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
Psoriasis Area and Severity Index
Description
Psoriasis. ASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 to 72.Higher score indicates worse psoriasis.
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
Physician Global Assessment (PGA)
Description
Psoriasis. Scores range from 100 (extremely high functioning) to 1 (severely impaired).
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
Dermatology Life Quality Index (DLQI)
Description
Psoriasis. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. The DLQI can also be expressed as a percentage of the maximum possible score of 30.
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Title
Kansas City Cardiomyopathy Questionnaire
Description
Heart Failure with reduced ejection fraction. In the KCCQ, an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status
Time Frame
At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lina Khoury Aerts, PhD
Phone
0045 61660623
Email
lkho0011@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lone Skov, Professor
Phone
0045 38673204
Email
lone.skov.02@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
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Mind-Body Approaches for Medical Conditions
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