Acceptance and Commitment TherapyACT-DENCT05563987
ACT-DE for Diabetes Distress in Adults With Type 2 Diabetes: A Pilot RCT
A study testing ACT-DE and DE in people with Acceptance and Commitment Therapy and Type 2 Diabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Acceptance and Commitment Therapy, Type 2 Diabetes, Diabetes Distress
- What is being tested?
- ACT-DE and DE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2021to 30 Mar 2022
- 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 content.
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.
About this study
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
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.
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.
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.
- Being tested
- ACT-DE, DE
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-DEBehavioural
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.
DEBehavioural
DE
| Study group | Role | What they receive |
|---|---|---|
| ACT-DE | Experimental | The proposed intervention was a six-week acceptance-based diabetes education programme (ACT-DE) programme comprising Acceptance and Commitment Therapy (ACT) and diabetes education (DE). it included one diabetes education session (1st session), three ACT sessions (2nd to 4th), and a booster session in the 6th week conducted by the researcher. Each session lasted about 120 minutes in groups of 6 participants. The sessions were delivered face-to-face. Receives: Behavioral: ACT-DE |
| DE | Active comparator | participants in the control group only received one session of diabetes education with the same session duration. Receives: Behavioral: DE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline (T0) and immediate post-intervention (T1)
Secondary outcomes (3)
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) and immediate post-intervention (T1)
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) and immediate post intervention (T1)
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.
Measured: baseline (T0) and immediate post-intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Oct 2021
- Primary completion28 Feb 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance and Commitment TherapyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 were random allocated (1:1 ratio) to either the intervention group that received a 6-week (5 sessions) group-based ACT-DE programme. While participants in the control group received 1 session of diabetes education.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Ngan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563987
- Sponsor's protocol ID
- ACT-DE for Diabetes Distress
- Acronym
- ACT-DE
- Status last verified
- Oct 2022
- First submitted
- 29 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05563987
- Acronym / sponsor ID
- ACT-DE / ACT-DE for Diabetes Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 3 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were random allocated (1:1 ratio) to either the intervention group that received a 6-week (5 sessions) group-based ACT-DE programme. While participants in the control group received 1 session of diabetes education.
| Arm | Type | Receives |
|---|---|---|
| ACT-DE | Experimental | Behavioral: ACT-DEThe proposed intervention was a six-week acceptance-based diabetes education programme (ACT-DE) programme comprising Acceptance and Commitment Therapy (ACT) and diabetes education (DE). it included one diabetes education session (1st session), three ACT sessions (2nd to 4th), and a booster session in the 6th week conducted by the researcher. Each session lasted about 120 minutes in groups of 6 participants. The sessions were delivered face-to-face. |
| DE | Active comparator | Behavioral: DEparticipants in the control group only received one session of diabetes education with the same session duration. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-DEThe 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. | Behavioural | ACT-DE |
| DEDE | Behavioural | DE |
Primary outcome
Change in Diabetes Distress Scale
Time frame: baseline (T0) and immediate post-intervention (T1)
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.
3 secondary outcomes
Diabetes self-management behaviours
Time frame: baseline (T0) and immediate post-intervention (T1)
Diabetes management self-efficacy
Time frame: baseline (T0) and immediate post intervention (T1)
Psychological flexibility
Time frame: baseline (T0) and immediate post-intervention (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-DE and DE in people with Acceptance and Commitment Therapy and Type 2 Diabetes, 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 6 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: finished, as of the sponsor's last update on 4 Oct 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diabetes Distress Scale (time frame: baseline (T0) and immediate post-intervention (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2022.