Trial Review

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Trial registered on ANZCTR


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] 305012 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 323182 0
Metabolic syndrome 323183 0
Condition category
Condition code
Public Health 320765 320765 0 0
Health promotion/education
Metabolic and Endocrine 321017 321017 0 0
Diabetes
Metabolic and Endocrine 321018 321018 0 0
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] 321407 0
Treatment: Other
Intervention code [2] 321408 0
Lifestyle
Intervention code [3] 321409 0
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] 328580 0
Glycated hemoglobin (HbA1c%) from the patient's medical records of Ningbo First Hospital.
Timepoint [1] 328580 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [1] 399525 0
Fasting blood glucose (FBG: mmol/L) from the patient's medical records of Ningbo First Hospital.
Timepoint [1] 399525 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [2] 399526 0
Two hours postprandial blood glucose (2hPBG: mmol/L) from the patient's medical records of Ningbo First Hospital.
Timepoint [2] 399526 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [3] 399527 0
Systolic blood pressure (SBP: mmHg) from the patient's medical records of Ningbo First Hospital.
Timepoint [3] 399527 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [4] 399528 0
Diastolic blood pressure (DBP: mmHg) from the patient's medical records of Ningbo First Hospital.
Timepoint [4] 399528 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [5] 399529 0
Total cholesterol (TC: mmol/L) from the patient's medical records of Ningbo First Hospital.
Timepoint [5] 399529 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [6] 399530 0
Triglycerides (TG: mmol/L) from the patient's medical records of Ningbo First Hospital.
Timepoint [6] 399530 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [7] 399531 0
Low-density lipoprotein cholesterol (LDL-C: mmol/L) from the patient's medical records of Ningbo First Hospital.
Timepoint [7] 399531 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [8] 399532 0
High-density lipoprotein cholesterol (HDL-C: mmol/L) from the patient's medical records of Ningbo First Hospital.
Timepoint [8] 399532 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [9] 399533 0
Body mass index (BMI: kg/m2) from the patient's medical records of Ningbo First Hospital.


Timepoint [9] 399533 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [10] 399562 0
Waist hip ratio (WHR) from the patient's medical records of Ningbo First Hospital.
Timepoint [10] 399562 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [11] 400397 0
Visceral fat (cm) from the patient's medical records of Ningbo First Hospital.
Timepoint [11] 400397 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [12] 400398 0
Mean change of Patient Health Questionnaire-9 score (depression symptoms)
Timepoint [12] 400398 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [13] 400399 0
Mean change of General Anxiety Disorder-7 score (anxiety symptoms)
Timepoint [13] 400399 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [14] 400400 0
Mean change of The short-form quality-of-life questionnaire score (quality of life)
Timepoint [14] 400400 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [15] 400401 0
Mean change of The Summary of Diabetes Self-Care Activities score (self-care ability)
Timepoint [15] 400401 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [16] 400402 0
Mean change of The Pittsburgh Sleep Quality Index score (quality of sleep)
Timepoint [16] 400402 0
(1) At baseline; (2) Immediately after the intervention
Secondary outcome [17] 400451 0
Mean change of The Diabetes Knowledge Test score (diabetes knowledge awareness)
Timepoint [17] 400451 0
(1) At baseline; (2) Immediately after the intervention

Eligibility
Key inclusion criteria
Key inclusion criteria:
(1) The participants will be recruited from the Endocrinology Department of Ningbo First Hospital, Ningbo city, Zhejiang province, China. Recruited participants will be included in this research if they meet the following criteria:
1) Diagnosed type 2 diabetes (T2DM) with comorbid metabolic syndrome (MS);
2) Age 18-75 years old;
3) Currently does not participate in similar intervention programs;
4) Sign an informed consent form, willing to participate in this study, and have good compliance.
(2) The specific diagnostic criteria for diabetes refer to the report of the WHO Diabetes Expert Committee, 1999, which is as follows: typical symptoms of diabetes plus
1) random blood glucose greater than or equal to 11.1 mmol/L;
2) fasting blood glucose greater than or equal to 7.0 mmol/L;
3) oral glucose tolerance test 2 hours greater than or equal to 11.1 mmol/L;
4) When there is no definite hyperglycemia, it should be confirmed by repeated tests.
(3) The specific diagnostic criteria for metabolic syndrome refers to the IDF standard (Alberti et al., 2005; Collaborators):
central obesity, WC greater than or equal to 90cm (Chinese male) or greater than or equal to 80cm (Chinese female), and those who have 2 or more of the following components,
1) TG greater than or equal to 1.70mmol/L or have received relevant treatment;
2) HDL-C less than 1.03mmol/L (male) or less than 1.30mmol/L (female), or have received relevant treatment;
3) SBP greater than or equal to 130 or DBP greater than or equal to 85mmHg, or have received relevant treatment;
4) FPG greater than or equal to 5.6mmol/L or have been diagnosed with T2DM.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if 1) T1DM; 2) they are pregnant; 3) taking medications unrelated to T2DM or MS; 4) had advanced diabetes complications; 5) had a severe mental illness, is not able to answer questions and participate in intervention activities; 6) cannot use the mobile phone.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
(1) Stata 15 software will be used for analysis, in which the P-value is bilateral probability and the test level 0.05. The Shapiro-Wilk test will be used to check data normality.
(2) For continuous variables, descriptive analyses will be presented as mean and standard deviation. Independent two-sample t-tests will be used to assess the between-group differences in constant demographic characteristics and clinical variables at baseline. For the categorical variables, the descriptive analysis will be presented as percentages. A chi-square test will be used to assess the between-group differences in categorical variables at baseline.
(3) The independent variable is the groups (CBT-based intervention vs. usual intervention). In contrast, the dependent variables were physiological variables, including HbA1c, FBG, 2PBG, TC, TG, LDL-C, HDL-C, blood pressure, BMI, WHR, visceral fat; psychological variables, depression, and anxiety symptoms; cognitive behavior-changing indicators, including cognition changes, health-related behaviors changes, awareness of disease knowledge; quality of life and sleep quality. The intention to treat method will be used to assess the effectiveness of the intervention program, with patients retaining in their original group, regardless of program completion. The multiple-imputation will be used to estimate missing values.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/10/2021
Actual
Date of last participant enrolment
Anticipated
8/02/2022
Actual
Date of last data collection
Anticipated
2/08/2022
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 24037 0
China
State/province [1] 24037 0
Zhejiang Province, Ningbo City, Ningbo First Hospital

Funding & Sponsors
Funding source category [1] 309401 0
University
Name [1] 309401 0
Griffith University
Country [1] 309401 0
Australia
Primary sponsor type
University
Name
Grifftih University
Address
School of Medicine and Dentistry, Griffith University, Parklands Drive, Southport, Gold Coast, 4222, Queensland, Australia
Country
Australia
Secondary sponsor category [1] 310376 0
None
Name [1] 310376 0
None
Address [1] 310376 0
None
Country [1] 310376 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309207 0
Ethics Committee of Ningbo First Hospital
Ethics committee address [1] 309207 0
(1) 51 Liuting Street, Ningbo City, Zheijng Province, China
(2) Postal code: 315010
Ethics committee country [1] 309207 0
China
Date submitted for ethics approval [1] 309207 0
28/06/2021
Approval date [1] 309207 0
29/07/2021
Ethics approval number [1] 309207 0
2021-R073

Summary
Brief summary
(1) The number of diabetic patients in China is increasing rapidly, and previous studies have shown that cognitive-behavioral therapy (CBT) positively impacts patients' health outcomes. However, there is no application of this method in type 2 diabetes (T2DM) patients with comorbid metabolic syndrome (MS) Therefore, this study aims: to fill in this research gap by conducting a randomised controlled trial to evaluate the effectiveness of CBT on health outcomes in T2DM patients with comorbid MS; to guide patients to interpret disease events correctly, identify the controllable and uncontrollable aspects of the diseases, and stimulate patients' motivation for change; to help patients establish a good lifestyle and gradually improve their self-health management ability; to explore whether the intervention project guided by CBT can improve the physiological indexes, psychological indexes, and quality of life of T2DM patients with comorbid MS; to provide a scientific basis for CBT application in the intervention of Chinese diabetes patients with comorbid MS; and to fill the gap in the research content and develop and enrich the mode and range of chronic disease management intervention of diabetes. Considering that some diabetic patients live far away from the hospital and cannot go to the endocrinology clinic to participate in all the sessions, this study will adopt the combination of face-to-face and online intervention modes. And this is a PhD project being conducted by a PhD candidate at Griffith University.
(2) The proposed research will conduct a randomised controlled trial to evaluate the efficacy of CBT-based intervention on various aspects of wellbeing in type 2 diabetes patients with comorbid metabolic syndrome. Levels of patients’ well-being will be analyzed via various outcome variables. They will include the HbA1c, FBG, 2PBG, TC, TG, LDL-C, HDL-C, blood pressure, BMI, WHR, and visceral fat, depression symptoms, anxiety symptoms, cognition changes, health-related behaviors changes, awareness of disease knowledge, quality of life, sleep quality. We aim to provide evidence for the efficacy of CBT via an empirical study.
(3) Hypotheses
Hypothesis 1: CBT-based interventions significantly improve physiological factors in T2DM with comorbid MS, including HbA1c, FBG, 2PBG, TC, TG, LDL-C, HDL-C, blood pressure, BMI, WHR, and visceral fat.
Hypothesis 2: CBT-based interventions significantly improve psychological factors in T2DM patients with comorbid MS, including depression and anxiety symptoms.
Hypothesis 3: CBT-based interventions significantly improve the cognition changes, behavior changes, and knowledge awareness rate in T2DM patients with comorbid MS, including health-related behavior changes, awareness of disease knowledge.
Hypothesis 4: CBT-based interventions significantly improve quality of life and sleep quality in T2DM patients with comorbid MS.
Trial website
Trial related presentations / publications
Public notes
(1) This study is the PhD program of Yanni Li. Griffith University sponsors her via Griffith University International Postgraduate Research Scholarship. There are no other financial sponsors other than this.
(2) One literature review about this trial has been published online. The detail is as follows:
Li Y, Buys N, Li Z, Li L, Song Q, Sun J. The efficacy of cognitive-behavioral therapy-based interventions on patients with hypertension: A systematic review and meta-analysis. Prev Med Rep. 2021 Jul 6;23:101477. DOI: 10.1016/j.pmedr.2021.101477. PMID: 34285871.

Contacts
Principal investigator
Name 113342 0
A/Prof Jing Sun
Address 113342 0
School of Medicine and Dentistry, Griffith University, Parklands Drive, Southport, Gold Coast, 4222, Queensland, Australia
Country 113342 0
Australia
Phone 113342 0
+61 7 5678 0924
Fax 113342 0
Email 113342 0
[email protected]
Contact person for public queries
Name 113343 0
A/Prof Jing Sun
Address 113343 0
School of Medicine and Dentistry, Griffith University, Parklands Drive, Southport, Gold Coast, 4222, Queensland, Australia
Country 113343 0
Australia
Phone 113343 0
+61 7 5678 0924
Fax 113343 0
Email 113343 0
[email protected]
Contact person for scientific queries
Name 113344 0
A/Prof Jing Sun
Address 113344 0
School of Medicine and Dentistry, Griffith University, Parklands Drive, Southport, Gold Coast, 4222, Queensland, Australia
Country 113344 0
Australia
Phone 113344 0
+61 7 5678 0924
Fax 113344 0
Email 113344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12831Study protocol    382571-(Uploaded-11-08-2021-16-22-26)-Study-related document.pdf
12832Statistical analysis plan    382571-(Uploaded-11-08-2021-16-22-52)-Study-related document.pdf
12834Ethical approval    382571-(Uploaded-11-08-2021-16-23-10)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe evaluation of cognitive-behavioral therapy-based intervention on type 2 diabetes patients with comorbid metabolic syndrome: a randomized controlled trial.2023https://dx.doi.org/10.1186/s13098-023-01100-2
N.B. These documents automatically identified may not have been verified by the study sponsor.