Feasibility of a Tailored Online Self-compassion Intervention

Canterbury Christ Church University

Status: Enrolling

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus (T2DM)

Treatments: Behavioral: Feasibility RCT of a tailored online self-compassion intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07051005

ETH2425-0223

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Online Intervention

Experimental group

Description:

Four Week Online Self-Compassion Course

Treatment:

Behavioral: Feasibility RCT of a tailored online self-compassion intervention

Waitlist Control

No Intervention group

Description:

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.