ANZCTR - Registration

Registration number

ACTRN12621001348842

Ethics application status

Approved

Date submitted

11/08/2021

Date registered

7/10/2021

Date last updated

7/10/2021

Date data sharing statement initially provided

7/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

The efficacy of cognitive-behavioral therapy-based intervention on Type II diabetes patients with comorbid metabolic syndrome—a randomised controlled trial

Scientific title

The effect of cognitive-behavioral therapy-based intervention on HbA1c of Type II diabetes patients with comorbid metabolic syndrome—a randomised controlled trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 2 diabetes

Metabolic syndrome

Condition category

Condition code

Public Health

Health promotion/education

Metabolic and Endocrine

Diabetes

Metabolic and Endocrine

Other metabolic disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

(1) This study is an intervention study, a randomised controlled trial. Firstly, patients will be randomly grouped into the intervention group or control group by random numbers generated by SPSS. Then, patients will be allocated to social media groups of 8-10 according to the time of enrolment, and there will be about 28 social media groups in total, including 14 intervention social media groups and 14 social control groups, respectively. We will not make recommendations or adjustments to their medication regimen, which is not included in our research, no matter which group they are in.
(2) The purpose for the social media group of the intervention condition: we will send the intervention schedule into the group and remind patients to attend the intervention session one day before the session date; share session materials one day before the session date; do the online intervention, including explaining the intervention materials and Q&A; send the after-session quiz link to the group and remind patients to do this quiz; ask patients to upload pictures of their homework to the group, and give them feedback weekly; answer their other questions weekly during the 6 month time.
(3) Participants in the intervention group will receive the usual intervention + cognitive-behavioral therapy (CBT) - based intervention.
(4) For the usual intervention, there will be one 30min individual face-to-face health education session at the baseline time, at the endocrinology clinic, Ningbo First Hospital, Zhejiang Province, China, including taking medicine as prescribed by the clinician, how to keep a healthy eating habit, how to keep a scientific exercise habit according to the Guidelines for the Prevention and Treatment of Type 2 Diabetes (T2DM) in China (2020 Edition). The 30 min health education session will be a semi-formal presentation involving slides, and discussion with the therapist.
(5) The CBT intervention consisted of twelve sessions. Each session lasts for about 45-60 mins. The first face-to-face session will be done at the baseline after the usual intervention; other intervention sessions will be done according to the timeline. There will be eight weekly sessions in the first two months. There will be four monthly sessions in the following four months. The first session, the fourth session, the ninth session, and the twelfth session will be held in the endocrinology clinic individually. The face-to-face session will be recorded in the form of audio or video. At the same time, the rest of the sessions will be conducted through group video conference via social media and will be recorded by audio. After each CBT intervention, there will be one after-session quiz and homework on the theme of this session, which is required to be finished in one week after an intervention session. There will be 12 after-session quizzes and homework in total. It takes about 10 minutes to finish the homework for one session, and it takes about 2 minutes to complete the online after-session quiz for one session. If the after-session quiz score is less than 6, we will follow up with the patient, explain again the content of this week's session. This measure is to improve the patient’s understanding of the intervention content and improve their adherence. The mode of administration for CBT intervention is a semi-structured discussion led by the therapist, including the semi-formal presentation involving slides and discussions between patients and therapist.
The contents of the 12 sessions are as follow:
1) Develop a treatment alliance and set treatment goals together.
2) Psychological education and normalization—develop a list of problems related to the disease.
3) Use exposure therapy—common complications of diabetes (DM).
4) Use Socrates Questions—strengthen self-blood glucose monitoring.
5) Negative thinking substitution—maintain dietary nutrition and common diet-related distortions.
6) Negative thinking substitution—maintain moderate exercise and common exercise-related distortions.
7) Negative thinking substitution—adherence to drug use and common drug-related cognitive distortions.
8) Use the cognitive triangle—identification and diagnosis of automatic thinking related to DM/Metabolic syndrome (MS).
9) Use cognitive technology—identification, diagnosis, and replacement of distorted cognitive perceptions associated with DM/MS.
10) Use behavioral technology—identification, diagnosis, and replacement of distorted cognition associated with DM/MS.
11) Use exposure therapy—stop smoking and limit alcohol and develop good habits.
12) Psychological education and normalization—level 3 prevention of diabetes.
(6) The attendance record table will be used to record their attendance condition, including if they attend the session; if they finish the after session-quiz; if they upload their homework.
(7) The intervention time of the project is six months. The scale evaluation will be done at the baseline and post-intervention. It takes about 30 mins to finish the questionnaires. Participants can choose to answer the paper questionnaire or do the online survey.
(8) The therapist is Yanni Li, who has participated in The 5th China Baker CBT Training from July 4, 2020, to September 3, 2020, held by Beijing Anding Hospital. She has passed the final examination and is qualified to use CBT to do psychotherapy. In addition, all the intervention sessions will be recorded by audio or video for quality assessment by professor Zhanjiang Li and professor Jing Sun, all of whom are experienced psychotherapists.
(9) Yanni Li will be responsible for all the usual interventions and CBT interventions. Professor Sun will help to do the CBT intervention session if Yanni Li could not complete all the intervention sessions.
(10) As for the strategies to increase participants’ adherence:
1) Provide free counseling/support for patients during the trial: Yann Li will be responsible for answering the questions in the social media group during the 6 months intervention time.
2) Offer convenient appointment times: the face-to-face sessions will be arranged with patients’ regular visits to the hospital; session materials and audio files will be uploaded to the online group session before the online sessions, which will remain available for the patients who are not able to attend a certain session.
3) Assist with participants’ routine doctor’s visits.
4) There will be frequent intervention sessions during the first two months, avoiding large gaps between study contact on trial, maintaining close links during the start stage of the study.
5) Send out reminders before the intervention session: Yanni Li will send reminders to the social media group one day before the session. As for the session materials, Yanni Li will send them to the social media group one day before the session.
6) Communication is key between participants and clinical staff. Yanni Li will communicate with patients in a gentle, kind, and patient manner during the whole research time.
7) For participants who don’t want to continue the intervention session, Yanni Li will encourage them to stay in the study. But the final decision is entirely based on the participant's wishes.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

(1) This study is an intervention study, a randomised controlled trial. Firstly, patients will be randomly grouped into the intervention group or control group by random numbers generated by SPSS. Then, patients will be allocated to social media groups of 8-10 according to the time of enrolment, and there will be about 28 social media groups in total, including 14 intervention social media groups and 14 social control groups, respectively. We will not make recommendations or adjustments to their medication regimen, which is not included in our research, no matter which group they are in.
(2) The purpose for the social media group of the control condition: we will remind patients to go to the clinic for regular review monthly; answer their questions weekly during the 6 month time.
(3) Participants in the control group will receive the usual intervention. there will be one 30min individual face-to-face health education session at the baseline time, at the endocrinology clinic, Ningbo First Hospital, Zhejiang Province, China, including taking medicine as prescribed by the clinician, how to keep a healthy eating habit, how to keep a scientific exercise habit according to the Guidelines for the Prevention and Treatment of Type 2 Diabetes (T2DM) in China (2020 Edition). The 30 min health education session will be a semi-formal presentation involving slides, and discussion with the therapist.
(4) The study of the project is six months. The scale evaluation will be done at the baseline and post-intervention. It takes about 30 mins to finish the questionnaires. Participants can choose to answer the paper questionnaire or do the online survey.
(5) The therapist is Yanni Li, she will be responsible for the whole usual intervention. The endocrinologist Ye Zhou will help to do the usual intervention (30 min health education) based on the slides if Yanni Li could not complete all the usual intervention sessions.
(6) The attendance record table will be used to record their attendance condition, including if they attend the baseline usual intervention.

Control group

Active

Outcomes

Primary outcome [1]

Glycated hemoglobin (HbA1c%) from the patient's medical records of Ningbo First Hospital.

Timepoint [1]