ACT-DE for Diabetes Distress in Adults With Type 2 Diabetes: A Pilot RCT

NCT05563987 | Completed DMC

• 1 other identifier: ACT-DE for Diabetes Distress
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Acceptance and Commitment Therapy; Type 2 Diabetes; Diabetes Distress

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline (T0) and immediate post-intervention (T1)

Secondary Outcomes (3)

• Diabetes self-management behaviours

  baseline (T0) and immediate post-intervention (T1)

• Diabetes management self-efficacy

  baseline (T0) and immediate post intervention (T1)

• Psychological flexibility

  baseline (T0) and immediate post-intervention (T1)

Study Arms (2)

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.

Behavioral: ACT-DE

DE

ACTIVE COMPARATOR

participants in the control group only received one session of diabetes education with the same session duration.

Behavioral: DE

Interventions

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.

ACT-DE

DE BEHAVIORAL

DE

DE

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Female and Male
• 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 content.

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)

Ms Anna Ngan

Hong Kong, 00852, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

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 of participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: October 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: March 30, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)