ACT-DE for Diabetes Distress and HbA1c in Adults With Type 2 Diabetes — ACT-DE  

Acceptance and Commitment Therapy Clinical Trial

Official title: The Effects of Acceptance-based Diabetes Education on Diabetes Distress and Glycaemic Control in Adults With Type 2 Diabetes: A Randomised Controlled Trial.

Status Recruiting

Clinical Trial Summary

This study will evaluate the effectiveness of a structured acceptance-based diabetes education programme for adults with type 2 diabetes compared with those who received diabetes education. The programme mainly comprises acceptance and commitment therapy (ACT) as a psychological component and a diabetes education (DE) component. The short form of the programme is named 'ACT-DE'. This programme aims to decrease the diabetes distress level in participants with type 2 diabetes and improve their blood glucose level. The objectives are:

1. To develop an ACT-based intervention protocol as a guide for promoting healthy coping in people with type 2 diabetes who are psychologically distressed.

2. To examine the effects of 'ACT-DE' on diabetes distress and HbA1c (primary outcomes) over a three-month follow-up, when compared with diabetes education only.

3. To examine the effects of 'ACT-DE' on diabetes self-management behaviours, self-efficacy in diabetes care, and psychological flexibility (secondary outcomes) over the three-month follow-up, when compared with diabetes education; and

4. To identify the relationships between psychological flexibility and diabetes self-efficacy, diabetes self-management behaviour and HbA1c among the study participants

Clinical Trial Description

Diabetes distress is an aversive feeling and emotional disturbance specific to diabetes, including the burden of daily self-care, worry and guilty feelings, and low satisfaction level with health care professionals. Around 36% of people with type 2 diabetes worldwide suffered from diabetes distress, which is associated with poor self-care performance, low self-efficacy in diabetes management and higher blood glucose levels. Acceptance and commitment therapy, one of the mindfulness and acceptance-based interventions, integrated with diabetes education are found to be potentially effective interventions for reducing diabetes distress.

A pilot study has been conducted earlier (NCT05563987) and showed that a six-week ACT-DE programme (5 sessions) was preliminary effective compared to attending only one session of diabetes education. It was also a feasible and acceptable intervention.

In this main study, a convenience sampling method will be adopted from three out-patient clinics of public hospitals in Hong Kong. A total of 176 eligible participants will be randomly allocated into the intervention (N=88) and the control group (N=88). Participants in the intervention group will receive 6-week ACT-DE programme (5 sessions) composing acceptance and commitment therapy and diabetes education. Each session last for 120 minutes in a group of 8-10 participants. Participants in the control group will receive one session of diabetes education. ;

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy
• Diabetes Distress
• Diabetes Mellitus
• Diabetes Self-management
• HbA1c
• Psychological Flexibility

• NCT number: NCT05584085
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Contact: Anna Ngan, PhD candidate
• Phone: +85239434487
• Email: annangan@cuhk.edu.hk
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2022
• Completion date: November 30, 2023