An interventional study of ACT-DE in Acceptance and Commitment Therapy, Diabetes Education and Diabetes Distress, sponsored by Chinese University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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:
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.
Chinese University of Hong Kong is the lead sponsor of 1,446 studies on the registry; 467 are open to participants now.
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The proposed intervention is a six-week acceptance-based diabetes education programme (ACT-DE) comprising acceptance and commitment therapy and diabetes education. Session 1: Diabetes education and introduction of ACT-DE programme Session 2: Mindfulness cultivation Session 3: Value clarification Session 4: Integrating ACT into diabetes self-management Session 5: Booster session Session length: 120 minutes Group-based (6-8 participants) and face-to-face mode of delivery
Behavioral: ACT-DE
One session of diabetes education, group-based (6-8 participants) and 120 minutes via face-to-face delivery.
Behavioral: ACT-DE
Acceptance and Commitment Therapy is a third-wave psychological therapy to cultivate participants' acceptance attitude to diabetes and motivate them for a value-driven persistent diabetes self-management, directed by six psychological processes in the ACT hexagonal model, including acceptance, cognitive defusion, the present moment, self-as-context, value clarification and committed action.
Change from baseline Diabetes Distress Scale at 3 months post intervention
Diabetes distress will be measured by the Chinese 15-item Diabetes Distress Scale (CDDS-15). It consists of 15 items. rated on a six-point Likert scale from 1 = 'not a problem' to 6 = 'a serious problem'. A mean item score of 2-2.9 and ≥3.0 indicates moderate and severe distress, respectively.
Time frame: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)
Change from baseline HbA1c at 3 months post-intervention
Blood glucose level of participants will be evaluated with an HbA1c level, which measures the average blood glucose level during the past three months. An HbA1c level over 7% is considered suboptimal glycaemic control, indicating a high risk of diabetes complications.2 HbA1c values obtained every 3-4 months will be collected from the patient electronic information system.
Time frame: Baseline (T0), and 3-month post-intervention (T2)
Diabetes self-management behaviours
was measured by the Chinese version of diabetes self-management activities (C-SDSCA). It has 11 items rated on an eight-point Likert scale from 0 to 7, with higher scores indicating more attention to self-management activities.
Time frame: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)
Diabetes management self-efficacy
was measured by the Chinese version of Diabetes Management Self-Efficacy Scale (C-DMSES). The C-DMSES contains 20 items rated on an 11#point Likert scale, in which zero indicates not at all confident, and 10 indicates very confident.
Time frame: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)
Psychological flexibility
was measured by the Chinese version of the Acceptance and Action Questionnaire (AAQ-II Chinese). It contains seven items rated on a seven-point, agreement-based response scale from 1 = 'never true' to 7 = 'always true'. The \- Page 3 of 5 - AAQ-II will be scored by summing all item responses, with higher scale scores indicating a greater psychological inflexibility.
Time frame: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)
Plan to share: Undecided
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