Mind-Body Approaches for Medical Conditions

NCT03888261 | Unknown

• 1 other identifier: Mind-Body
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis; Psoriasis; Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• SF36: Physical Component Summary (PCS)

  At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

• SF36: Mental Component Summary (MCS)

  At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

• Illness Perception Questionnaire

  At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

• Pittsburgh sleep quality index

  At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

• High-sensitivity C-reactive protein (hs-CRP)

  At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

Other Outcomes (9)

• Disease activity score 28 based on C-reactive protein (DAS28-CRP)

  At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

• Tender joints

  At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

• Swollen joints

  At baseline, 10-12 weeks (1-2 weeks post-intervention), and 26 weeks from baseline

Study Arms (2)

Active Intervention:

ACTIVE COMPARATOR

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

Behavioral: Mind-Body Approaches for Medical Conditions

No Intervention

NO INTERVENTION

No intervention (Study participants will receive routine clinical practice)

Interventions

Mind-Body Approaches for Medical Conditions 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.

Active Intervention:

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rheumatoid arthritis:
• RA according to the 1987 revised American College of Rheumatology criteria
• Not selected on the basis of their level of activity.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gentofte, Copenhagen: lead
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• University of Copenhagen: collaborator
• Musculoskeletal Statistics Unit, The Parker Institute: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid; Psoriasis; Heart Failure

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Lina Khoury Aerts, PhD

CONTACT

0045 61660623; lkho0011@regionh.dk

Lone Skov, Professor

CONTACT

0045 38673204; lone.skov.02@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post-doctoral Researcher

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: March 25, 2019
• Study Start: April 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 25, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share