ACT-DE for Diabetes Distress and HbA1c in Adults With Type 2 Diabetes
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About
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:
- To develop an ACT-based intervention protocol as a guide for promoting healthy coping in people with type 2 diabetes who are psychologically distressed.
- 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.
- 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
- To identify the relationships between psychological flexibility and diabetes self-efficacy, diabetes self-management behaviour and HbA1c among the study participants
Full 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.
Enrollment
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Inclusion criteria
- community-dwelling adults Hong Kong Chinese residents,
- aged 18-64,
- diagnosed with type 2 diabetes for over one year;
- at least moderate level of diabetes distress as measured with the Chinese
- Diabetes Distress Scale (CDDS-15; mean score >2 per item);
- having suboptimal blood glucose control as shown by HbA1c level of ≥ 7% in the laboratory results within the past six months;
- able to communicate in Cantonese and give written consent
Exclusion criteria
- history of a clinically diagnosed mental illness such as depression and anxiety disorder, and/or an acute/severe medical disease;
- noticeable cognitive impairment(s) as indicated by the total score (<6 of 10) of the Abbreviated Mental Test;
- recently received/receiving any psychological therapy such as mindfulness or acceptance-based therapy.
Trial design
Primary purpose
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Interventional model
Masking
176 participants in 2 patient groups, including a placebo group
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Central trial contact
Anna Ngan, PhD candidate
Data sourced from clinicaltrials.gov
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