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

NCT05584085 | Unknown DMC

• 1 other identifier: ACT-DE for DD and HbA1c
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

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:

1. 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. 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. 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. 4.To identify the relationships between psychological flexibility and diabetes self-efficacy, diabetes self-management behaviour and HbA1c among the study participants

Conditions

Acceptance and Commitment Therapy; Diabetes Education; Diabetes Distress; HbA1c; Psychological Flexibility; Diabetes Self-management; Diabetes Management Self-efficacy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Diabetes self-management behaviours

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

• Diabetes management self-efficacy

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

• Psychological flexibility

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

Study Arms (2)

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

EXPERIMENTAL

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

Diabetes education

PLACEBO COMPARATOR

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

Behavioral: ACT-DE

Interventions

ACT-DE BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Nethersole School of Nursing

Hong Kong, Hong Kong Island, Hong Kong

RECRUITING

Central Study Contacts

Anna Ngan, PhD candidate

CONTACT

+85239434487; annangan@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor who is responsible for collecting outcome data and data entry has no idea about the group allocation or participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 5, 2022
• First Posted: October 18, 2022
• Study Start: October 15, 2022
• Primary Completion: August 31, 2023
• Study Completion: November 30, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

HK (1)