Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05584085
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2022-10-05
Brief Title:
ACT-DE for Diabetes Distress and HbA1c in Adults With Type 2 Diabetes
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT-DE
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 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
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
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 N88 and the control group N88 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
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 N88 and the control group N88 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None