Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04032496
Status:
UNKNOWN
Last Update Posted:
2019-12-20
First Post:
2019-06-27
Brief Title:
Contemplation-Based Intervention and Health Outcomes RCT in Lupus Patients
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
A Randomized Controlled Trial to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
METHODS A randomized controlled trial of 50 SLE patients in which subjects receive either a 6-week MBI treatment n25 or a 6-week psychoeducation treatment n25
SCREENING At Visit 1 participants who are deemed eligible for the study will be assigned to either a mindfulness-based intervention group or a psychoeducation intervention group Participants will also complete the following questionnaires which will also be administered throughout the intervention schedule
1 Adverse Childhood Experience ACE
2 Adult Attachment Style Questionnaire AAS closeness subscale
3 Brief Health Mindset Scale BHMS
4 Center for Epidemiological Studies Depression Scale Revised CESD-R
5 Inclusion of Other Self IOS
6 Interpersonal Reactivity Index IRI empathic concern and perspective-taking subscales
7 Interpersonal Regulation Questionnaire IRQ
8 LupusPRO patient only
9 MacArthur Scales of Subjective Social Status Community and Socioeconomic Status
10 Caregiver Burden Questionnaire support person only
11 Multidimensional Scale of Perceived Social Support MSPSS
12 Pain Catastrophizing Scale PCS
13 Ruminative Responses Scale RRS short form
14 Social Interaction Phobia Scale SIPS
15 State Trait Anxiety Inventory STAI-T STAI-S
16 Ten Item Big Five Questionnaire
17 Toronto Mindfulness Scale TMS
18 Lupus Quality of Life
19 CAM Health Belief Questionnaire
INTERVENTIONS All participants will complete either a 6-week mindfulness-based intervention or a 6-week psychoeducation intervention All sessions will be in-person in a group setting and accompanied by homework For both interventions participants will practice what they learned on a daily basis as their homework However the mindfulness intervention may also have videoaudio homework to complete Sessions 1-5 will last approximately 2 hours each The final 6th session will be a retreat that will last approximately 4 hours Questionnaire data will be collected throughout the intervention
ASSESSMENTS Assessment visits 1 and 9 will be performed by rheumatologists and include complete history physical examination information about SLE drug treatment and laboratory examination Lupus disease activity and damage will be measured by Systemic Lupus Erythematosus Disease Activity Index 2000 SLEDAI-2K and systemic Lupus International Collaborating ClinicsAmerican College of Rheumatology Damage Index SDI respectively Information on socio-demographics clinical variables SLEDAI-2K and SDI co-morbidities dyslipidemia atherosclerosis cerebrovascular disease and others are collected as part of the and will be made available for the analysis in this study Lupus serology including C3C4 anti-ds DNA antibodies and routine blood test including complete blood count test and chemistry panel are also collected regularly during the patients visits to the clinic and will be made available for the analysis in this study
fMRI Tasks Participants will complete a series of questionnaires completed within 24 hours after the visit via Qualtrics and a series of tasks while functional MRI data is recorded After the fMRI there will be four cognitive tasks done on the computer outside of the scanner These include
Continuous Associative Binding CAB The goal of this task is to track different aspects of memory and decision-making in particular the ability of individuals to form associations between pairs of items presented at the same time In the tasks participants are presented with pairs of images of objects eg a pencil and a lamp and their job is to indicate whether the have seen that exact pair of images presented together in the present block of trials
Flanker The goal of the flanker task is to measure inhibitory control and decision-making In each trial participants are presented with a cluster of arrows pointing either left or right The task is for the participant to indicate the direction the arrow in the center of the cluster of arrows is pointing
Random Dot Motion RDM The goal of this task is to track attention and perceptual decision-making In each trial participants see a circle filled with dots moving in different directions Most of the dots are moving in random directions but some of the dots are moving coherently either left or right The task of the participant is to indicate either by the keyboard or touch screen whether more coherent dots are moving to the right or left
Balloon Analog Risk Task BART The goal of this task is to track risk-taking behavior reinforcement learning and decision-making On each trial the participant indicates whether they would like to pump more air into the balloon increasing the amount of pointsmoney they could earn if they collect before the balloon pops or whether they want to collect what they have earned and add it to the bank If they pump and the balloon pops they lose the chance to collect that money for that balloon
Support people will complete a series of questionnaires completed within 24 hours after the visit via Qualtrics and the Handholding Task The support person is the partner and will be asked to hold hands with the patient for the partner portion of the task The support person will be connected to the shock device STM100C Stimulator Module BIOPAC Systems for one round of the task and the shock level will be calibrated to their pain tolerance
After the fMRI there will be four cognitive tasks done on the computer outside of the scanner These include the same tasks for the participant listed above
For the scan standard procedures for removal of all participant ferromagnetic objects eg wristwatches will be implemented and the procedures of the study will be reviewed insuring that participants have an opportunity to ask any remaining questions All standard fMRI safety screening procedures will be done prior to the fMRI and female participants will take a urine based pregnancy test Participants will complete the following tasks while in the scanner
Resting State Task Mindfulness training has been shown to alter resting state connectivity in areas related to emotions and stress eg Taren et al 2015 Thus we will record resting state data in all visits Participants will be asked to rest in the scanner Following the resting state scans participants will also complete selected questions from the Amsterdam Resting State Questionnaire 20 to provide subjective descriptions of their experience
Hand holding Task The handholding task is a measure the social regulation of the neural response to threat Each trial involves the presentation of 12 threat and 12 safety cues in randomized order across blocks of approximately 7 minutes Participants and partners will be told that threat cues indicate a 17 chance of mild electric shock These basic threat paradigms will be repeated across 3 blocks of threatsafety cues and counterbalanced across subjects These blocks will include the alone condition and the partner hand holding condition in the Threat to Self task and the partner hand holding condition in the Threat to Partner task Electric shock will be delivered via an automated computer controlled device STM100C Stimulator Module BIOPAC Systems to the ankle 4 mA cf Tursky OConnell 1972 The shock level will be calibrated to each participants pain tolerance
Resting State Task a second time
All fMRI conditions will be followed by ratings using the Self-Assessment Manikins
ANALYSIS The main analysis is planned when all patients have concluded the MBI or psychoeducational program all data have been entered verified and validated and the primary database has been locked Following data reduction and preparation analysis of all self-report and biological eg fMRI data will be conducted using hierarchical multilevel modeling procedures designed to maximize sensitivity to both within- and between- subject sources of variation across time including baseline measurements pre- and post- intervention In addition to testing for specific group-level effects of intervention individual differences in response to treatment andor in biological measures will be assessed as a function of self-report data at both state and trait levels modeled as interaction effects in multilevel models
SCREENING At Visit 1 participants who are deemed eligible for the study will be assigned to either a mindfulness-based intervention group or a psychoeducation intervention group Participants will also complete the following questionnaires which will also be administered throughout the intervention schedule
1 Adverse Childhood Experience ACE
2 Adult Attachment Style Questionnaire AAS closeness subscale
3 Brief Health Mindset Scale BHMS
4 Center for Epidemiological Studies Depression Scale Revised CESD-R
5 Inclusion of Other Self IOS
6 Interpersonal Reactivity Index IRI empathic concern and perspective-taking subscales
7 Interpersonal Regulation Questionnaire IRQ
8 LupusPRO patient only
9 MacArthur Scales of Subjective Social Status Community and Socioeconomic Status
10 Caregiver Burden Questionnaire support person only
11 Multidimensional Scale of Perceived Social Support MSPSS
12 Pain Catastrophizing Scale PCS
13 Ruminative Responses Scale RRS short form
14 Social Interaction Phobia Scale SIPS
15 State Trait Anxiety Inventory STAI-T STAI-S
16 Ten Item Big Five Questionnaire
17 Toronto Mindfulness Scale TMS
18 Lupus Quality of Life
19 CAM Health Belief Questionnaire
INTERVENTIONS All participants will complete either a 6-week mindfulness-based intervention or a 6-week psychoeducation intervention All sessions will be in-person in a group setting and accompanied by homework For both interventions participants will practice what they learned on a daily basis as their homework However the mindfulness intervention may also have videoaudio homework to complete Sessions 1-5 will last approximately 2 hours each The final 6th session will be a retreat that will last approximately 4 hours Questionnaire data will be collected throughout the intervention
ASSESSMENTS Assessment visits 1 and 9 will be performed by rheumatologists and include complete history physical examination information about SLE drug treatment and laboratory examination Lupus disease activity and damage will be measured by Systemic Lupus Erythematosus Disease Activity Index 2000 SLEDAI-2K and systemic Lupus International Collaborating ClinicsAmerican College of Rheumatology Damage Index SDI respectively Information on socio-demographics clinical variables SLEDAI-2K and SDI co-morbidities dyslipidemia atherosclerosis cerebrovascular disease and others are collected as part of the and will be made available for the analysis in this study Lupus serology including C3C4 anti-ds DNA antibodies and routine blood test including complete blood count test and chemistry panel are also collected regularly during the patients visits to the clinic and will be made available for the analysis in this study
fMRI Tasks Participants will complete a series of questionnaires completed within 24 hours after the visit via Qualtrics and a series of tasks while functional MRI data is recorded After the fMRI there will be four cognitive tasks done on the computer outside of the scanner These include
Continuous Associative Binding CAB The goal of this task is to track different aspects of memory and decision-making in particular the ability of individuals to form associations between pairs of items presented at the same time In the tasks participants are presented with pairs of images of objects eg a pencil and a lamp and their job is to indicate whether the have seen that exact pair of images presented together in the present block of trials
Flanker The goal of the flanker task is to measure inhibitory control and decision-making In each trial participants are presented with a cluster of arrows pointing either left or right The task is for the participant to indicate the direction the arrow in the center of the cluster of arrows is pointing
Random Dot Motion RDM The goal of this task is to track attention and perceptual decision-making In each trial participants see a circle filled with dots moving in different directions Most of the dots are moving in random directions but some of the dots are moving coherently either left or right The task of the participant is to indicate either by the keyboard or touch screen whether more coherent dots are moving to the right or left
Balloon Analog Risk Task BART The goal of this task is to track risk-taking behavior reinforcement learning and decision-making On each trial the participant indicates whether they would like to pump more air into the balloon increasing the amount of pointsmoney they could earn if they collect before the balloon pops or whether they want to collect what they have earned and add it to the bank If they pump and the balloon pops they lose the chance to collect that money for that balloon
Support people will complete a series of questionnaires completed within 24 hours after the visit via Qualtrics and the Handholding Task The support person is the partner and will be asked to hold hands with the patient for the partner portion of the task The support person will be connected to the shock device STM100C Stimulator Module BIOPAC Systems for one round of the task and the shock level will be calibrated to their pain tolerance
After the fMRI there will be four cognitive tasks done on the computer outside of the scanner These include the same tasks for the participant listed above
For the scan standard procedures for removal of all participant ferromagnetic objects eg wristwatches will be implemented and the procedures of the study will be reviewed insuring that participants have an opportunity to ask any remaining questions All standard fMRI safety screening procedures will be done prior to the fMRI and female participants will take a urine based pregnancy test Participants will complete the following tasks while in the scanner
Resting State Task Mindfulness training has been shown to alter resting state connectivity in areas related to emotions and stress eg Taren et al 2015 Thus we will record resting state data in all visits Participants will be asked to rest in the scanner Following the resting state scans participants will also complete selected questions from the Amsterdam Resting State Questionnaire 20 to provide subjective descriptions of their experience
Hand holding Task The handholding task is a measure the social regulation of the neural response to threat Each trial involves the presentation of 12 threat and 12 safety cues in randomized order across blocks of approximately 7 minutes Participants and partners will be told that threat cues indicate a 17 chance of mild electric shock These basic threat paradigms will be repeated across 3 blocks of threatsafety cues and counterbalanced across subjects These blocks will include the alone condition and the partner hand holding condition in the Threat to Self task and the partner hand holding condition in the Threat to Partner task Electric shock will be delivered via an automated computer controlled device STM100C Stimulator Module BIOPAC Systems to the ankle 4 mA cf Tursky OConnell 1972 The shock level will be calibrated to each participants pain tolerance
Resting State Task a second time
All fMRI conditions will be followed by ratings using the Self-Assessment Manikins
ANALYSIS The main analysis is planned when all patients have concluded the MBI or psychoeducational program all data have been entered verified and validated and the primary database has been locked Following data reduction and preparation analysis of all self-report and biological eg fMRI data will be conducted using hierarchical multilevel modeling procedures designed to maximize sensitivity to both within- and between- subject sources of variation across time including baseline measurements pre- and post- intervention In addition to testing for specific group-level effects of intervention individual differences in response to treatment andor in biological measures will be assessed as a function of self-report data at both state and trait levels modeled as interaction effects in multilevel models
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None