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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05563987
Study type	Interventional
Source	Chinese University of Hong Kong
Contact
Status	Completed
Phase	N/A
Start date	October 1, 2021
Completion date	March 30, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms