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Completed

NCT Number: NCT05749029

An Online, Compassion Intervention for Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM).

The goal of this research study is to evaluate a 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salomons Institute for Applied Psychology, Canterbury Christ Church University, 1 Meadow Road

Royal Tunbridge Wells, Tunbridge Wells, TN1 2YG, United Kingdom

About this study

This Randomised Controlled Trial (RCT) will compare a CMT intervention for people with Type 1 and Type 2 Diabetes Mellitus with a waitlist control group who will be given access after the study.

The outcome measures will be completed at baseline (week 0), post-intervention (week 4), and at follow-up (week 8).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resident in the United Kingdom;
  • Clinician diagnosed Type 1 Diabetes Mellitus or Type 2 Diabetes Mellitus;
  • Self-managing condition;
  • Diabetes diagnosed over a year ago.

Exclusion criteria

  • Diagnosis of Gestational Diabetes or Pre-Diabetes.
  • Current severe mental health condition;
  • Currently self-harming or suicidal;
  • Currently engaging in psychological therapy.

Treatment and study plan

Four Week Self-Compassion Course

Behavioral

This is a four-week self-compassion course supplied by Balanced Minds. The owner of Balanced Minds is a Consultant to this study, who will be providing access to participants.

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.

Other names: Online Self-Compassion Course

Primary outcomes

  1. Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to post-intervention (week 4).

    Time frame: Post-intervention (week 4)

    The DDS is a 17-item measure of problems and hassles related to diabetes.

    The DDS establishes a total mean score and a mean score for its four sub-scales. Scores will range from 1 to 6. Mean scores of 3 or above is considered distress worthy of clinical attention.

Secondary outcomes

  1. Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to post-intervention (week 4).

    Time frame: Post-intervention (week 4)

    The EISS is an eight-item scale measuring external and internal dimensions of shame.

    Higher scores indicate higher levels of shame and a total score varies between 8 and 40.

  2. Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to post-intervention (week 4).

    Time frame: Post-intervention (week 4)

    The FSCRS is a 22-item scale with statements measuring inadequate self, hated self and reassured self.

    Scores will range from 0 to 88.

  3. Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to post-intervention (week 4).

    Time frame: Post-intervention (week 4)

    The FCS is a 15-item measure of fear of compassion towards self.

    Scores will range from 0 to 60. Higher scores indicate greater fear of compassion.

  4. Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and post-intervention (week 4).

    Time frame: Post-intervention (week 4)

    14-item measure assessing mental wellbeing in the non-clinical sample. Scores on the WEMWBS will range from 14 to 70. Higher scores indicate greater positive mental wellbeing.

  5. Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) and post-intervention (week 4).

    Time frame: Post-intervention (week 4)

    The CEAS is a 13-item measure of compassionate engagement and action.

    The engagement sub-scale will establish a score between 6 and 60.

    The action sub-scale will establish a score between 4 and 40.

  6. Change in HbA1c from baseline (week 0) to follow-up (week 8).

    Time frame: Follow-up (week 8)

    Participants will be asked to self-report a blood glucose (HbA1c) level taken by a healthcare provider in the past three to six months at baseline and at one-month post-intervention.

    Higher HbA1c levels indicate poorer diabetes control.

  7. Change in Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS) scores at baseline (week 0) and follow-up (week 8).

    Time frame: Follow-up (week 8)

    Please see description above.

  8. Change in the total score on the External and Internal Shame Scale (EISS) from baseline (week 0) to follow-up (week 8).

    Time frame: Follow-up (week 8)

    Please see description above.

  9. Change in Forms of Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS) scores from baseline (week 0) to follow-up (week 8).

    Time frame: Follow-up (week 8)

    Please see description above.

  10. Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to follow-up (week 8).

    Time frame: Follow-up (week 8)

    Please see description above.

  11. Change in Fears of Compassion Scale (FCS) scores from baseline (week 0) to follow-up (week 8)

    Time frame: Follow-up (week 8)

    Please see description above.

  12. Change in Compassionate Engagement and Action Scale (CEAS) scores at baseline (week 0) to follow-up (week 8).

    Time frame: Follow-up (week 8)

    Please see description above.

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Registry information

Official study title

An Online, Compassion Intervention to Improve Shame, Self-criticism, and Physical Wellbeing in Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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