Mind-Body Approaches for Medical Conditions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2020-01-01

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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis Psoriasis Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Active Intervention:

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

Group Type ACTIVE_COMPARATOR

Mind-Body Approaches for Medical Conditions

Intervention Type BEHAVIORAL

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.

No Intervention

No intervention (Study participants will receive routine clinical practice)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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:

1. Contemplative practices
2. Psychoeducation
3. Dialogue, including therapist-group dialogue as well as participant-participant dialogue.

Intervention Type BEHAVIORAL

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

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).

* Ability to participate
* Psychopathology: Persons with severe mental illness are excluded.
* Alcohol and/ or drug abuse
* Impaired cognitive functions

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No