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

NCT ID: NCT05749029

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-12-12

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Type 1 Diabetes Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Intervention

Group Type EXPERIMENTAL

Four Week Self-Compassion Course

Intervention Type 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.

Waitlist Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Four Week Self-Compassion Course

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Online Self-Compassion Course

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canterbury Christ Church University

OTHER

Sponsor Role lead

Responsible Party

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Hetashi Bawa

Trainee Clinical Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alan Hebben-Wadey, DClinPsy

Role: STUDY_DIRECTOR

Canterbury Christ Church University

Hetashi Bawa, BSc, MSc

Role: PRINCIPAL_INVESTIGATOR

Canterbury Christ Church University

Locations

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

Royal Tunbridge Wells, Tunbridge Wells, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Hetashi Bawa MRP 2021

Identifier Type: -

Identifier Source: org_study_id

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