Feasibility of a Tailored Online Self-compassion Intervention

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

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-18

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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This pilot randomised controlled trial seeks to examine the feasibility and acceptability of online compassion training tailored for adults living with Type 1 and Type 2 diabetes. Participants will be randomised to either the compassion training course or a waitlist control group, in which participants will be offered the intervention at the end of the study. Four self-report measures will be administered online at baseline (weeks 0-1) and post-intervention (weeks 9-10). The indices of feasibility and acceptability that will be examined include: 1. ease of recruitment; 2. participant retention in the intervention; 3. participant retention in the study; 4. acceptability of the intervention; 5. outcome measure completion; 6. whether there is a preliminary signal of efficacy on the primary outcome measure (diabetes distress). These indices will be compared to progression criteria which determine whether the intervention is sufficiently feasible and acceptable to progress to a full-scale RCT in future research.

Conditions

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Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus (T2DM)

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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Online Intervention

Four Week Online Self-Compassion Course

Group Type EXPERIMENTAL

Feasibility RCT of a tailored online self-compassion intervention

Intervention Type BEHAVIORAL

This 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.

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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Feasibility RCT of a tailored online self-compassion intervention

This 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* \<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
* Individuals currently experiencing severe substance abuse issues that could interfere with participation in the programme
* Individuals without reliable access to the internet and a compatible device (computer or smartphone).

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No