A Randomized, Controlled Trial to Increase Self-compassion and Decrease Caregiving Fatigue in Group Leaders of a Support Group for Women After Cancer (GLOW) - an Adaption of the Mindful Self-Compassion Program for Healthcare Communities
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- self-compassion as assessed by Self-compassion scale in german version (SCS-D)
Study Overview
Brief Summary
This exploratory study aims to evaluate the effect of a self-compassion training developed for health professionals on leaders of self-help groups.
Hypothesis/primary goal: An online group intervention adapted from the "Self-compassion for health-care communities program" validated for health professionals leads to an increase in self-compassion among leaders of cancer self-help groups. Secondary goals: level of self-compassion at the end of the course as a mediator for therapeutic variables after 6 weeks, decrease in caregiver fatigue, secondary traumatic stress/burnout risk, personal distress and sick leave, decrease in fears of self-compassion/compassion for others; increase in mindfulness, self-efficacy, compassion for others and resilience; direct costs; safety;
Intervention:
Online group intervention: led by a certified mindfulness teacher for Mindful Self-Compassion and additional qualification in Self-Compassion in Healthcare Communities (duration: 6 weekly appointments of 90 min each); control intervention: waiting group
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Group leaders of a self-help group for cancer patients
- •written informed consent
Exclusion Criteria
- •Medical or mental condition that, in the opinion of the investigator, does not allow the participant to take part in the study or to provide a legally valid signature of the informed consent (e.g. insufficiently controlled pre-existing mental illness or post-traumatic stress disorder)
- •Lack of willingness to store and share personal health data as part of the protocol
- •Participation in another mindfulness study
- •Lack of knowledge of German
Arms & Interventions
Self-compassion training
Online group intervention: led by a certified mindfulness teacher for mindful self-compassion and additional qualification in self-compassion in healthcare communities (duration: 6 weekly appointments of 90 min each);
Intervention: Self-compassion training (Behavioral)
waiting list control
waiting list control
Outcomes
Primary Outcomes
self-compassion as assessed by Self-compassion scale in german version (SCS-D)
Time Frame: 6 weeks after baseline
Determining self-compassion after the intervention by means of a confirmatory test for group differences in the primary endpoint according to the ITT principle using a linear regression model; instrument: SCS-D
Secondary Outcomes
- secondary traumatic stress/burnout risk as assesd by ProQoL(12 weeks after baseline)
- Decrease in compassion fatigue as assessed by ProQoL(12 weeks after baseline)
- personal distress (PSS-10)(12 weeks after baseline)
- increase in resilience (BRS)(12 weeks after baseline)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(12 weeks after baseline)
- decrease in fears of self-compassion (FCS)(12 weeks after baseline)
- compassion for others (COS-7)(12 weeks after baseline)
- increase in mindfulness (FFMQ)(12 weeks after baseline)
- increase in self-efficacy (SWE)(12 weeks after baseline)
Investigators
Dr. Claudia Loeffler
PD Dr. med., Senior physician
Wuerzburg University Hospital