Feasibility of a Tailored Online Self-compassion Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorCanterbury Christ Church University
About this trial
The goal of this clinical trial is to examine the feasibility and acceptability of an online programme that is based on Compassionate Mind Training (CMT) over four-weeks. The programme intends to share information and strategies to reduce diabetes distress, self-criticism, and shame, and improve physical health in people who have Type 1 and Type 2 Diabetes Mellitus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old or older.
Diagnosed with Type 1 or Type 2 diabetes by a clinician in the NHS more than one year ago.
Self-managing theircondition.
Identified by their NHS team as needing support with their mental health due to diabetes-related distress.
Disqualifiers
<18
Individuals experiencing a current mental health crisis, including severe depression, active suicidal thoughts, or acute psychosis
Unable to read/speak English
Gestational diabetes, Wolfram, and other rarer conditions
Trial design
Design model
Parallel
Treatments tested in this trial
Feasibility RCT of a tailored online self-compassion intervention
BehavioralThis is a four-week online self-compassion course supplied by Balanced Minds. The researches of this study and an Expert by Experience have consulted with the owner of Balanced Minds to tailor this programme to people with diabetes. The self-help, self-compassion course is based on Compassionate Mind Training. This provides participants with opportunities to develop skills and attributes of compassion through a weekly 30-minute video on a specified topic, a 10-minute compassionate exercise that participants are encouraged to engage in daily for the week and a brief summary of the compassionate topic. The topics of the course are: The Foundations of Self-Compassion Developing your Compassionate Self Deepening the Compassionate Relationship with Yourself Self-compassion in Everyday Life.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Online InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of participants recruited
The number of participants recruited over 6-months will be compared against the following progression criterion to assess the feasibility of recruitment: Green: 40-50; Amber 24-39; Red: \<24.
Time frame
6 months following the start of recruitment2
Proportion of intervention group participants who complete at least half of the compassion training course intervention sessions
The proportion of participants who completed at least half of the intervention sessions will be compared against the following progression criterion to assess retention in the intervention: Green: ≥50%; Amber 25-49%; Red: \<25%.
Time frame
Weeks 2 to 83
Proportion of study participants who remain in the study
The proportion of study participants who remain in the study will be compared against the following progression criterion to assess retention in the study: Green: ≥50%; Amber 25-49%; Red: \<25%.
Time frame
Weeks 0 to 104
Compassion training course acceptability
Response to Likert type questions and content analysis of qualitative data will be compared against the following progression criterion to assess retention in the study: Green: the majority of intervention participants report the intervention is acceptable as it is or with minor adjustments; Amber: there are inconsistent reports of acceptability or the intervention requires bigger adjustments; Red: the majority of intervention participants report the intervention is unacceptable or requires adjustments which cannot be completed.
Time frame
Weeks 9 to 10Secondary outcomes
1
Estimate of the between group effect size of compassion training intervention compared to control on change in the Forms of Self-Criticising/ Attacking & Self-Reassuring (FSCRS) Scale from baseline (weeks 0-1) to post-intervention (weeks 9-10).
The FSCRS is a 22-item self-report measure developed to measure self-criticism and the ability to self-reassure. The scale comprises three subscales: Inadequate-Self, which focuses on feelings of personal inadequacy, Hated-Self, measuring the desire to hurt or punish oneself, and Reassured-Self, which is an ability to reassure and support the self.
Time frame
Weeks 9-102
Estimate of the between group effect size of compassion training intervention compared to control on change in the External and Internal Shame Scale (EISS) from baseline (weeks 0-1) to post-intervention (weeks 9-10).
This is an eight-item scale informed by the evolutionary, biopsychosocial model measuring external and internal dimensions of shame. Research shows that individuals with chronic physical health conditions report higher levels of internal and external shame.
Time frame
Weeks 9-103
Estimate of the between group effect size of compassion training intervention compared to control on change in the Compassionate Engagement and Action Scale (CEAS) from baseline (weeks 0-1) to post-intervention (weeks 9-10).
The scale has been validated to measure self-compassion through engagement, by assessing engagement with sensitivity, sympathy, non-judgement, empathy, distress tolerance and caring, and self-compassion through action, by balanced reasoning, focusing attention on helpful contexts, actions that alleviate distress and cultivating inner support to alleviate distress. The 13-item sub-scale within the CEAS will be used (compassion to self).
Time frame
Weeks 9-10Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Canterbury Christ Church University
Lead sponsor
Barts & The London NHS Trust
Collaborator
Betsi Cadwaladr University Health Board
Collaborator
Source ClinicalTrials.gov