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

NCT05749029 | Completed

• 1 other identifier: Hetashi Bawa MRP 2021
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Compassion Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Diabetes Distress Scale (DDS) scores from baseline (week 0) to 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.

  Post-intervention (week 4)

Secondary Outcomes (12)

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

  Post-intervention (week 4)

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

  Post-intervention (week 4)

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

  Post-intervention (week 4)

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

  Post-intervention (week 4)

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

  Post-intervention (week 4)

Study Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Four Week Self-Compassion Course

Waitlist Control

NO INTERVENTION

Control participants will receive no intervention during the study but will be given the option of accessing the online self-compassion intervention after the study is complete.

Interventions

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: 1. The Foundations of Self-Compassion 2. Developing your Compassionate Self 3. Deepening the Compassionate Relationship with Yourself 4. Self-compassion in Everyday Life.

Also known as: Online Self-Compassion Course

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Canterbury Christ Church University: lead

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alan Hebben-Wadey, DClinPsy

  Canterbury Christ Church University

  STUDY DIRECTOR

• Hetashi Bawa, BSc, MSc

  Canterbury Christ Church University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All the outcome measures will be self-report questionnaires that will be completed by an online automated system with no involvement of the research team.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: May 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 12, 2023
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)