Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)

Sponsor

University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT05002842

Collaborator

(none)

979

Enrollment

Location

Arms

Actual Duration (Months)

139.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

CaringBridge (CB) is an online health community for people undergoing challenging health journeys. This platform provides an opportunity for individuals and their caregivers to rally support for a loved-one during a health journey. CaringBridge offers the opportunity for expressive writing through journal entries, wellbeing resources, participant health journey stories, and practical scheduling and communication tools to support community, healing, and wellbeing. Loving Kindness Meditation (LKM) is a systemized mind-body approach developed to increase loving acceptance and has been shown to increase resilience in the face of adversity. The aim of this study is to better understand how mind-body practices, like LKM, impact adult CB users

Condition or Disease	Intervention/Treatment	Phase
Cancer Stress	Behavioral: LovingKindess Meditation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

979 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Implementation of Mind-Body Practices in an Online Community of Caring (CaringBridge)

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate Intervention Those in the immediate intervention arm will begin the LovingKindess Meditation practice upon enrollment.	Behavioral: LovingKindess Meditation Participants will have access to a recording of a script to guide them through meditation
Experimental: Delayed Intervention Those in the deferred intervention arm will commence the LovingKindness Meditation practice intervention approximately 3 weeks (post 3 -week survey) after enrollment and participate three weeks thereafter.	Behavioral: LovingKindess Meditation Participants will have access to a recording of a script to guide them through meditation

Arm

Intervention/Treatment

Experimental: Immediate Intervention

Those in the immediate intervention arm will begin the LovingKindess Meditation practice upon enrollment.

Behavioral: LovingKindess Meditation

Participants will have access to a recording of a script to guide them through meditation

Experimental: Delayed Intervention

Those in the deferred intervention arm will commence the LovingKindness Meditation practice intervention approximately 3 weeks (post 3 -week survey) after enrollment and participate three weeks thereafter.

Behavioral: LovingKindess Meditation

Participants will have access to a recording of a script to guide them through meditation

Outcome Measures

Primary Outcome Measures

Change in Perceived Stress: The Perceived Stress Scale [3 weeks]
The Perceived Stress Scale is a 10-item scale for measuring one's perception of stress. All 10 items are assessed by asking how often a respondent felt a certain way on a 5-point Likert measure (0 = Never; 4 = Very Often), with a minimum score of 0 and a maximum score of 40. Higher total scores indicate greater perceived stress. This will be assessed at baseline and week three, in addition to week six for the deferred arm.

Secondary Outcome Measures

Change in Self-Compassion: The Self-Compassion Scale [3 weeks]
The Self-Compassion Scale (SCS) is a 12-item, shortened version of the original longer 26-item self-compassion scale (range 12-60). The 12-item SCS contains the same higher-order factor structure as the 26-item scale with a general Higher-Order Self-Compassion factor and six second-order factors of Self-Kindness, Self-Judgement, Common Humanity, Isolation, Mindfulness, and Over-Identification. All 12 items are assessed by asking how often a respondent felt a certain way on a 5-point Likert measure (1 =Almost never; 5 =Almost always). Higher SCS scores are associated with psychological well-being and suggest self-compassion might be an important protective factor, fostering emotional resilience. This will be assessed at baseline and week three, in addition to week six for the deferred arm.
Change in Compassionate Love: The Compassionate Love for Humanity Scale [3 weeks]
The Compassionate Love Scale (CLS) is a 21-item measure of the stranger-humanity version of the original CLS designed to measure compassionate love for humanity (range 38-147). Higher CLS scores indicate greater compassionate love for humanity. This will be assessed at baseline and week three, in addition to week six for the deferred arm.
Change in Social Support: The Social Connectedness Scale [3 weeks]
Social connectedness is assessed with 8 items on a 6-point Likert scale (1 = strongly agree through 6 = strongly disagree), with a total range of 8-48. Social connectedness is reverse coded such that high scores indicate higher social connection. This will be assessed at baseline and week three, in addition to week six for the deferred arm.
Change in Social Support: The Social Assurance Scale [3 weeks]
Social assurance is assessed with 8 items on a 6-point Likert scale (1 = strongly agree through 6 = strongly disagree), with a total range of 8-48. Social Assurance is reverse coded such that high scores indicate higher social assurance. This will be assessed at baseline and week three, in addition to week six for the deferred arm.