Contemplation-Based Intervention and Health Outcomes RCT in Lupus Patients

NCT04032496 | Unknown

• 1 other identifier: 34709
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to test the efficacy of an innovative contemplative-based and caregiver-inclusive intervention can modify pathogenic processes in systemic lupus erythematosus (SLE) compared to a psychoeducation-based intervention. Contemplative techniques such as meditation, mindfulness and yoga may have an impact on the disease burden and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. It is also well documented that social relationships moderate physical health. Incorporating patients' caregivers may strengthen their relationships and thereby improve their health and well-being. It is anticipated that the successful outcome of the mindfulness-based intervention described in this proposal will provide the basis for a new and effective contemplative-based and caregiver-inclusive therapy for SLE and other rheumatic diseases. Although we expect our mindfulness-based intervention to outperform our psychoeducation intervention, we note that the psychoeducation intervention is much closer to treatment as usual (especially insofar as many lupus patients are provided no psychosocial intervention whatever), and to that degree can reasonably be considered our best initial point of comparison. In practice, most patients would be provided medication and some basic information about living with the disease, as well as, perhaps, some additional guidance about coping with chronic stress and pain. We believe that our comparison condition goes beyond this to provide a bona fide intervention in itself.

Conditions

Lupus Erythematosus, Systemic

Outcome Measures

Primary Outcomes (1)

• Change from baseline in systemic lupus erythematosus (SLE) disease activity

  Change from baseline SLE Disease Activity Index 2000 (SLEDAI-2K) total score (range from 0 to 105 with higher values representing worse outcomes). Total score represents the sum of the central nervous system, vasculitis, musculoskeletal, renal, skin, serosal, immunologic, fever, and hematologic subscales.

  Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention

Secondary Outcomes (39)

• Change from baseline in brain activity during functional MRI

  Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention

• Change from baseline in organ-specific SLE disease activity (central nervous system subscale)

  Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention

• Change from baseline in organ-specific SLE disease activity (vasculitis subscale)

  Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention

• Change from baseline in organ-specific SLE disease activity (musculoskeletal subscale)

  Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention

• Change from baseline in organ-specific SLE disease activity (renal subscale)

  Baseline Assessment within 2 weeks prior to intervention, within 2 weeks after intervention

Study Arms (2)

Mindfulness Intervention

EXPERIMENTAL

Participants in this arm will participate in the Contemplative-Based Intervention for People Living with SLE intervention in addition to one baseline fMRI and blood analysis and one post-treatment fMRI and blood analysis.

Behavioral: Contemplative-Based Intervention for People Living with SLE

HEP Intervention

ACTIVE COMPARATOR

Participants in this arm will participate in the Health Enhancement Program (HEP) intervention in addition to one baseline fMRI and blood analysis and one post-treatment fMRI and blood analysis.

Behavioral: Health Enhancement Program (HEP)

Interventions

Contemplative-Based Intervention for People Living with SLE BEHAVIORAL

Intervention sessions will follow a 6-week format consisting of weekly in-person sessions as well as guided homework to encourage practice at home. Some mindfulness practices that will be included are meditation, group exercise (yoga), group discussions, and deep breathing. Both participants diagnosed with SLE as well as caregivers will participate in the intervention sessions. 5 sessions will be approximately 2 hours long, while the final session will be approximately 4 hours long. Each intervention group will include approximately 4 participants with SLE and 4 caregivers.

Mindfulness Intervention

Health Enhancement Program (HEP) BEHAVIORAL

The HEP was designed to create an active control for mindfulness-based stress reduction (MBSR) interventions. The structure of this intervention will mirror that of the other arm of this study, but will lack the mindfulness component. The HEP includes topics such as physical activity, functional movement, music therapy, and nutrition education.

HEP Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females who have given written informed consent
• years of age or older
• Literate in English: able to read, understand, follow instructions, and complete the rating scales and questionnaires accurately
• Have a clinical diagnosis of systemic lupus erythematosus
• Must pass the initial MRI screening
• Must be a participant in The University of Toronto Clinic and Database Research Program - Prognosis and Genetic Studies in Systemic Lupus Erythematosus
• Must be able to access the Internet regularly

You may not qualify if:

• Significant previous mindfulness training and experience (e.g. MBSR course, daily meditation practice)
• Any current Axis I DSM-IV-TR psychiatric disorder that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality.
• Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patients at undue risk.
• Chronic use of prescribed or recreational psychoactive drugs (self-reported)
• Current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline (self-reported)
• Too sick to meaningfully participate (e.g. hospitalized, flaring at the time of screening)
• In order to participate in the MRI portion of the study, participants must pass the in-person MRI screening administered by the MRI technician before each MRI. If participants fail the in-person MRI screening, they will be excluded from the MRI portion of the study, but can still participate in the intervention portion of the study.
• Is not a participant in The University of Toronto Clinic and Database Research Program - Prognosis and Genetic Studies in Systemic Lupus Erythematosus

Sponsors & Collaborators

• University of Toronto: lead
• University Health Network, Toronto: collaborator
• University of Virginia: collaborator

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• William A Cunningham, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moe Zandy, MPH

CONTACT

416-603-5800; Moe.Zandy@uhnresearch.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 25, 2019
• Study Start: January 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 20, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share