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

Type 2 Diabetes Clinical Trial

— ACT-DE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05563987
• Other study ID #: ACT-DE for Diabetes Distress
• Status: Completed
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: October 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 30, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acceptance and Commitment Therapy
• Diabetes Distress
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• ACT-DE
The acceptance and commitment therapy is a psychological component 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 hexagonal model of ACT, including acceptance, cognitive defusion, the present moment, self-as-context, value clarification and committed action.
• DE
DE

Locations

Country	Name	City	State
Hong Kong	Ms Anna Ngan	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Diabetes Distress Scale	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.	baseline (T0) and immediate post-intervention (T1)
Secondary	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.	baseline (T0) and immediate post-intervention (T1)
Secondary	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.	baseline (T0) and immediate post intervention (T1)
Secondary	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 AAQ-II will be scored by summing all item responses, with higher scale scores indicating a greater psychological inflexibility.	baseline (T0) and immediate post-intervention (T1)