ACT-DE for Diabetes Distress and HbA1c in Adults With Type 2 Diabetes (ACT-DE)

The Effects of Acceptance-based Diabetes Education on Diabetes Distress and Glycaemic Control in Adults With Type 2 Diabetes: A Randomised Controlled Trial.

This study will evaluate the effectiveness of a structured acceptance-based diabetes education programme for adults with type 2 diabetes compared with those who received diabetes education. The programme mainly comprises acceptance and commitment therapy (ACT) as a psychological component and a diabetes education (DE) component. The short form of the programme is named 'ACT-DE'. This programme aims to decrease the diabetes distress level in participants with type 2 diabetes and improve their blood glucose level. The objectives are:

1. To develop an ACT-based intervention protocol as a guide for promoting healthy coping in people with type 2 diabetes who are psychologically distressed.
2. To examine the effects of 'ACT-DE' on diabetes distress and HbA1c (primary outcomes) over a three-month follow-up, when compared with diabetes education only.
3. To examine the effects of 'ACT-DE' on diabetes self-management behaviours, self-efficacy in diabetes care, and psychological flexibility (secondary outcomes) over the three-month follow-up, when compared with diabetes education; and
4. To identify the relationships between psychological flexibility and diabetes self-efficacy, diabetes self-management behaviour and HbA1c among the study participants

Study Overview

• Status: Recruiting
• Conditions: Acceptance and Commitment Therapy; Diabetes Distress; Psychological Flexibility; Diabetes Self-management; HbA1c; Diabetes Education; Diabetes Management Self-efficacy
• Intervention / Treatment: Behavioral: ACT-DE

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.

A pilot study has been conducted earlier (NCT05563987) and showed that a six-week ACT-DE programme (5 sessions) was preliminary effective compared to attending only one session of diabetes education. It was also a feasible and acceptable intervention.

In this main study, a convenience sampling method will be adopted from three out-patient clinics of public hospitals in Hong Kong. A total of 176 eligible participants will be randomly allocated into the intervention (N=88) and the control group (N=88). Participants in the intervention group will receive 6-week ACT-DE programme (5 sessions) composing acceptance and commitment therapy and diabetes education. Each session last for 120 minutes in a group of 8-10 participants. Participants in the control group will receive one session of diabetes education.

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong Island
    • Hong Kong, Hong Kong Island, Hong Kong
      • Recruiting
      • The Nethersole School of Nursing
      • Contact: The NSO Nursing; Phone Number: +85296547323; Email: annangan@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 consent

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acceptance and commitment therapy integrated in diabetes education (ACT-DE); The proposed intervention is a six-week acceptance-based diabetes education programme (ACT-DE) comprising acceptance and commitment therapy and diabetes education. Session 1: Diabetes education and introduction of ACT-DE programme Session 2: Mindfulness cultivation Session 3: Value clarification Session 4: Integrating ACT into diabetes self-management Session 5: Booster session Session length: 120 minutes Group-based (6-8 participants) and face-to-face mode of delivery	Behavioral: ACT-DE; Acceptance and Commitment Therapy is a third-wave psychological therapy 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 ACT hexagonal model, including acceptance, cognitive defusion, the present moment, self-as-context, value clarification and committed action.
PLACEBO_COMPARATOR: Diabetes education; One session of diabetes education, group-based (6-8 participants) and 120 minutes via face-to-face delivery.	Behavioral: ACT-DE; Acceptance and Commitment Therapy is a third-wave psychological therapy 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 ACT hexagonal model, including acceptance, cognitive defusion, the present moment, self-as-context, value clarification and committed action.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Diabetes Distress Scale at 3 months post intervention	Diabetes distress will be 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), immediate post-intervention (T1) and 3-month post-intervention (T2)
Change from baseline HbA1c at 3 months post-intervention	Blood glucose level of participants will be evaluated with an HbA1c level, which measures the average blood glucose level during the past three months. An HbA1c level over 7% is considered suboptimal glycaemic control, indicating a high risk of diabetes complications.2 HbA1c values obtained every 3-4 months will be collected from the patient electronic information system.	Baseline (T0), and 3-month post-intervention (T2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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), immediate post-intervention (T1) and 3-month post-intervention (T2)
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), immediate post-intervention (T1) and 3-month post-intervention (T2)
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 - Page 3 of 5 - AAQ-II will be scored by summing all item responses, with higher scale scores indicating a greater psychological inflexibility.	Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2022
• Primary Completion (ANTICIPATED): August 31, 2023
• Study Completion (ANTICIPATED): November 30, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (ACTUAL): October 18, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: ACT-DE for DD and HbA1c

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No