Status:
UNKNOWN
Contemplation-Based Intervention and Health Outcomes RCT in Lupus Patients
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
University Health Network, Toronto
University of Virginia
Conditions:
Lupus Erythematosus, Systemic
Eligibility:
All Genders
18+ years
Phase:
NA
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) comp...
Detailed Description
METHODS: A randomized controlled trial of 50 SLE patients in which subjects receive either a 6-week MBI treatment (n=25) or a 6-week psychoeducation treatment (n=25). SCREENING: At Visit 1, participa...
Eligibility Criteria
Inclusion
- Males and females who have given written informed consent
- 18 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04032496
Start Date
January 1 2020
End Date
July 1 2021
Last Update
December 20 2019
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