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Acceptance and Commitment TherapyACT-DENCT05584085

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

A study testing ACT-DE in people with Acceptance and Commitment Therapy and Diabetes Education, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years
What is being tested?
ACT-DE
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
176 participants
Where
1 siteHong Kong
Study dates
15 Oct 2022to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Anna Ngan, PhD candidate contact

+85239434487

annangan@cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • The Nethersole School of Nursing

    Hong Kong, Hong Kong Island

    The NSO Nursing, +85296547323, annangan@cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

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.

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
Read the 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.

Being tested
ACT-DE

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT-DEBehavioural

    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.

Study groups in NCT05584085
Study groupRoleWhat they receive
Acceptance and commitment therapy integrated in diabetes education (ACT-DE)ExperimentalThe 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
Receives: Behavioral: ACT-DE
Diabetes educationPlacebo comparatorOne session of diabetes education, group-based (6-8 participants) and 120 minutes via face-to-face delivery.
Receives: Behavioral: ACT-DE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)

  2. 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.

    Measured: Baseline (T0), and 3-month post-intervention (T2)

Secondary outcomes (3)

  1. 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.

    Measured: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)

  2. 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.

    Measured: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)

  3. 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.

    Measured: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start15 Oct 2022
  3. Primary completion31 Aug 2023 (estimated)
  4. Study completion30 Nov 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Outcomes assessor
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05584085
Sponsor's protocol ID
ACT-DE for DD and HbA1c
Acronym
ACT-DE
Status last verified
Feb 2023
First submitted
5 Oct 2022
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing ACT-DE in people with Acceptance and Commitment Therapy and Diabetes Education, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Ngan, PhD candidate (+85239434487, annangan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline Diabetes Distress Scale at 3 months post intervention (time frame: Baseline (T0), immediate post-intervention (T1) and 3-month post-intervention (T2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05584085.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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