act-de for diabetes distress and hba1c in adults with type 2 diabetes

Conditions: Acceptance and Commitment Therapy; Diabetes Education; Diabetes Distress; HbA1c; Psychological Flexibility; Diabetes Self-management; Diabetes Management Self-efficacy

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

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.

Eligibility criteria:
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.