search
Back to results

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

Primary Purpose

Acceptance and Commitment Therapy, Diabetes Education, Diabetes Distress

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
ACT-DE
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acceptance and Commitment Therapy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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 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.

Sites / Locations

  • The Nethersole School of NursingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acceptance and commitment therapy integrated in diabetes education (ACT-DE)

Diabetes education

Arm Description

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

One session of diabetes education, group-based (6-8 participants) and 120 minutes via face-to-face delivery.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 5, 2022
Last Updated
February 6, 2023
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT05584085
Brief Title
ACT-DE for Diabetes Distress and HbA1c in Adults With Type 2 Diabetes
Acronym
ACT-DE
Official Title
The Effects of Acceptance-based Diabetes Education on Diabetes Distress and Glycaemic Control in Adults With Type 2 Diabetes: A Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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: To develop an ACT-based intervention protocol as a guide for promoting healthy coping in people with type 2 diabetes who are psychologically distressed. 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. 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 To identify the relationships between psychological flexibility and diabetes self-efficacy, diabetes self-management behaviour and HbA1c among the study participants
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acceptance and Commitment Therapy, Diabetes Education, Diabetes Distress, HbA1c, Psychological Flexibility, Diabetes Self-management, Diabetes Management Self-efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated (1:1 ratio) to either the intervention group that receive 1 6-week ACT-DE programme, while participants in the control group receive one session of diabetes education.
Masking
Outcomes Assessor
Masking Description
The outcome assessor who is responsible for collecting outcome data and data entry has no idea about the group allocation or participants.
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acceptance and commitment therapy integrated in diabetes education (ACT-DE)
Arm Type
Experimental
Arm Description
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
Arm Title
Diabetes education
Arm Type
Placebo Comparator
Arm Description
One session of diabetes education, group-based (6-8 participants) and 120 minutes via face-to-face delivery.
Intervention Type
Behavioral
Intervention Name(s)
ACT-DE
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Diabetes Distress Scale at 3 months post intervention
Description
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.
Time Frame
Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)
Title
Change from baseline HbA1c at 3 months post-intervention
Description
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.
Time Frame
Baseline (T0), and 3-month post-intervention (T2)
Secondary Outcome Measure Information:
Title
Diabetes self-management behaviours
Description
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.
Time Frame
Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)
Title
Diabetes management self-efficacy
Description
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.
Time Frame
Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)
Title
Psychological flexibility
Description
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.
Time Frame
Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Ngan, PhD candidate
Phone
+85239434487
Email
annangan@cuhk.edu.hk
Facility Information:
Facility Name
The Nethersole School of Nursing
City
Hong Kong
State/Province
Hong Kong Island
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
The NSO Nursing
Phone
+85296547323
Email
annangan@cuhk.edu.hk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs