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ACT-DE for Diabetes Distress in Adults With Type 2 Diabetes: A Pilot RCT

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status

Completed

Conditions

Type 2 Diabetes
Acceptance and Commitment Therapy
Diabetes Distress

Treatments

Behavioral: DE
Behavioral: ACT-DE

Study type

Interventional

Funder types

Other

Identifiers

NCT05563987
ACT-DE for Diabetes Distress

Details and patient eligibility

About

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.

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.

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.

Enrollment

48 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

48 participants in 2 patient groups

ACT-DE
Experimental group
Description:
The proposed intervention was a six-week acceptance-based diabetes education programme (ACT-DE) programme comprising Acceptance and Commitment Therapy (ACT) and diabetes education (DE). it included one diabetes education session (1st session), three ACT sessions (2nd to 4th), and a booster session in the 6th week conducted by the researcher. Each session lasted about 120 minutes in groups of 6 participants. The sessions were delivered face-to-face.
Treatment:
Behavioral: ACT-DE
DE
Active Comparator group
Description:
participants in the control group only received one session of diabetes education with the same session duration.
Treatment:
Behavioral: DE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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