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Clinical Trials/NCT05563987
NCT05563987
Completed
Not Applicable

The Effects of an Acceptance-based Diabetes Education (ACT-DE) Programme for Adults With Type 2 Diabetes on Diabetes Distress: a Pilot RCT

Chinese University of Hong Kong1 site in 1 country48 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acceptance and Commitment Therapy
Sponsor
Chinese University of Hong Kong
Enrollment
48
Locations
1
Primary Endpoint
Change in Diabetes Distress Scale
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
March 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anna Ngan

Principle Investigator

Chinese University of Hong Kong

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.

Outcomes

Primary Outcomes

Change in Diabetes Distress Scale

Time Frame: baseline (T0) and immediate post-intervention (T1)

Diabetes distress was 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.

Secondary Outcomes

  • Psychological flexibility(baseline (T0) and immediate post-intervention (T1))
  • Diabetes management self-efficacy(baseline (T0) and immediate post intervention (T1))
  • Diabetes self-management behaviours(baseline (T0) and immediate post-intervention (T1))

Study Sites (1)

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