Mind-Body Approaches for Medical Conditions

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

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 Overview

• Status: Unknown
• Conditions: Heart Failure; Rheumatoid Arthritis; Psoriasis
• Intervention / Treatment: Behavioral: Mind-Body Approaches for Medical Conditions

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lina Khoury Aerts, PhD; Phone Number: 0045 61660623; Email: lkho0011@regionh.dk
• Study Contact Backup: Name: Lone Skov, Professor; Phone Number: 0045 38673204; Email: lone.skov.02@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Intervention: Mind-body intervention (incl. Relaxation Response Resiliency Program & the Open and Calm Program)	Behavioral: Mind-Body Approaches for Medical Conditions; 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.
No Intervention: No Intervention; No intervention (Study participants will receive routine clinical practice)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity score 28 based on C-reactive protein (DAS28-CRP)	Rheumatoid Arthritis.	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Tender joints	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.	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Swollen joints	Rheumatoid Arthritis. Assessed by a train physician.	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
VAS-Pain	Rheumatoid Arthritis. Score range from 1-100. Higher score indicates worse pain.	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
VAS-Patient global assessment	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.	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Psoriasis Area and Severity Index	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.	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Physician Global Assessment (PGA)	Psoriasis. Scores range from 100 (extremely high functioning) to 1 (severely impaired).	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Dermatology Life Quality Index (DLQI)	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.	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline
Kansas City Cardiomyopathy Questionnaire	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	At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

Collaborators and Investigators

• Sponsor: University Hospital, Gentofte, Copenhagen
• Collaborators: Odense University Hospital; Aarhus University Hospital; Department of psychology, University of Copenhagen; Musculoskeletal Statistics Unit, The Parker Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: March 11, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: Mind-Body

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No