Mind-Body Approaches for Medical Conditions

University Hospital, Gentofte, Copenhagen

Status: Unknown

Conditions: Psoriasis; Heart Failure; Rheumatoid Arthritis

Treatments: Behavioral: Mind-Body Approaches for Medical Conditions

Study type: Interventional

Funder types: Other

Identifiers

NCT03888261

Mind-Body

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Active Intervention:

Active Comparator group

Description:

Mind-body intervention (incl. Relaxation Response Resiliency Program \& the Open and Calm Program)

Treatment:

Behavioral: Mind-Body Approaches for Medical Conditions

No Intervention

No Intervention group

Description:

No intervention (Study participants will receive routine clinical practice)