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NCT Number: NCT05563987

ACT-DE for Diabetes Distress in Adults With Type 2 Diabetes: 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.

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Key information

Conditions

Acceptance and Commitment Therapy Diabetes Distress Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ms Anna Ngan

Hong Kong, 00852

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACT-DE

Behavioral

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

Behavioral

DE

Primary outcomes

  1. 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.

Secondary outcomes

  1. Diabetes self-management behaviours

    Time frame: baseline (T0) and immediate post-intervention (T1)

    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.

  2. Diabetes management self-efficacy

    Time frame: baseline (T0) and immediate post intervention (T1)

    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.

  3. Psychological flexibility

    Time frame: baseline (T0) and immediate post-intervention (T1)

    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.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

The Effects of an Acceptance-based Diabetes Education (ACT-DE) Programme for Adults With Type 2 Diabetes on Diabetes Distress: a Pilot RCT

Acronym: ACT-DE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2022
Registry last updated
Oct 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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