Clinical trial NCT05563987: ACT-DE for Diabetes Distress in Adults With Type 2 Diabetes: A Pilot RCT
Official title: The Effects of an Acceptance-based Diabetes Education (ACT-DE) Programme for Adults With Type 2 Diabetes on Diabetes Distress: a Pilot RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acceptance and Commitment Therapy
Type 2 Diabetes
Diabetes Distress
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were random allocated (1:1 ratio) to either the intervention group that received a 6-week (5 sessions) group-based ACT-DE programme. While participants in the control group received 1 session of diabetes education.
Primary purpose: TREATMENT

Brief summary: This study is a pilot RCT to examine the feasibility, acceptability and preliminary effectiveness of a 6-week acceptance-based diabetes education programme (ACT-DE) on diabetes distress, self-care efficacy and behaviours of adults with type 2 diabetes in Hong Kong.

It is hypothesise that the ACT-DE programme will:

* Be acceptable, feasible and beneficial for adults with type 2 diabetes to improve their psychological distress and self-care.
* Significantly reduce participants' diabetes distress (primary outcomes), when compared with the usual care (control) group immediately post-intervention;
* Significantly improve self-care efficacy, self-care behaviour and psychological flexibility (secondary outcomes) than the control group immediately post-intervention.

Detailed 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.

Participants who agreed to participate in the study were randomly allocated into the intervention (N=24) and the control group (N=24). Participants in the intervention group received a 6-week group-based acceptance and commitment therapy integrated with diabetes education (ACT-DE). There were five sessions in 6 weeks with 120 minutes per session. The group size were 6. While participants in the control group received one session of diabetes education without any information on acceptance and commitment therapy.

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 content.

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.

Primary outcomes:
measure: Change in Diabetes Distress Scale
timeFrame: baseline (T0) and immediate post-intervention (T1)
Secondary outcomes:
measure: Diabetes self-management behaviours
timeFrame: baseline (T0) and immediate post-intervention (T1)
measure: Diabetes management self-efficacy
timeFrame: baseline (T0) and immediate post intervention (T1)
measure: Psychological flexibility
timeFrame: baseline (T0) and immediate post-intervention (T1)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Ms Anna Ngan
Study officials:
References: