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. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

Xu 2021.

Study characteristics
Methods Study design: cluster‐RCT
Duration of study: the study was conducted from July 2017 to October 2018.
Country: China
Income classification: upper‐middle income country in 2017‐2018
Geographical scope: Xuzhou City in north of Jiangsu Province, eastern China
Healthcare setting: community health service stations
Participants 1. Age: mean age for the intervention group 63.81 ± 9.94 years and for the control group 62.91 ± 9.59 years
2. Gender: both
3. Socioeconomic background: not specified
4. Educational background: mostly (548 participants completers) high school and above
Inclusion criteria:
a. type 2 diabetes mellitus diagnosed at least 6 months before recruitment;
b. Patient Health Questionnaire‐9 (PHQ‐9) scores ≥ 5 or Generalized Anxiety Disorder‐7 (GAD‐7) scores ≥ 5, and normal cognitive function at entry.
Exclusion criteria:
a. GAD‐7 scores < 5 or PHQ‐9 scores < 5;
b. psychiatric history or cognitive impairment;
c. severe diabetic complications;
d. active suicidal ideation or a history of attempted suicide;
e. taken antipsychotic drugs;
f. history of panic disorder or bipolar depression;
g. harmful or hazardous alcohol use;
h. participation in any other interventional clinical trial;
i. pregnancy;
j. lactation and medically unstable condition (e.g. cancer, stroke, cardiovascular disease, chronic obstructive pulmonary disease, severe psychosis);
k. participants with life expectancy less than 1 year;
l. unwillingness to participate in the study;
m. inability to regularly attend sessions (being absent for more than two sessions);
n. experience of severe crisis and stress before the study;
o. patients diagnosed as type 2 diabetes mellitus in the preceding 6 months.
Note: at baseline, the intervention and control group scores for GAD‐7 were, respectively, 7.60 (5.08) and 7.80 (4.84). At baseline, the intervention and control group scores for PHQ‐9 were, respectively, 7.09 (4.37) and 7.00 (4.70).
Stated purpose: to assess whether group cognitive behavioural therapy (GCBT) delivered by general practitioners reduces anxiety and depression and improves glycaemic levels in adults with type 2 diabetes mellitus
Interventions Name: GCBT
Title/name of PW and number: 75 trained general practitioners
1. Selection: general practitioners selected from 24 healthcare centres
2. Educational background: not specified
3. Training: 3 days of training on eight GCBT modules
4. Supervision: not specified
5. Incentives/remuneration: not specified
Prevention type: indicated – participants presented with some level of distress as indicated by the PHQ‐9 and GAD‐7 scores. All those with psychiatric history or cognitive impairment were excluded.
Intervention details: participants received 10 GCBT sessions in 10 consecutive days. Each session lasted 40 to 50 minutes and was followed by a 10‐ to 15‐minute discussion. After class, participants were asked to practice diaphragmatic breathing and progressive muscle relaxation daily before bedtime, to practice Baduanjin (a kind of traditional Chinese activity) every morning and evening, and to record their practice with a smartphone and send a short video to general practitioners for evaluation. Participants were also asked to record the timing and resolution of negative emotions, to narrate their problems and the needs of diabetes education.
Control: usual care (UC) by general practitioners of primary healthcare services. The UC included conventional face‐to‐face follow‐ups for adults with type 2 diabetes mellitus every 3 months and recording patient health status, monitoring blood glucose and blood pressure, according to the NBPHS requirement. General practitioners should also give advice to diet, exercise, glycaemic control, prevention of complications, side effects of drugs and medication for each patient during follow‐up.
Outcomes Participants’outcomes of interest for this review
  1. Anxiety symptoms – GAD‐7

  2. Depressive symptoms – PHQ‐9


Carers’outcomes of interest for this review
Nil
Economic outcomes
Nil
Time points: baseline, post‐intervention (1‐6 months, 7‐24 months)
Notes Source of funding: Preventive Medicine Research Projects of Jiangsu Province Health Department in 2015 and 2018 (Y2015010 and Y2018016), the Science and Technology projects of Xuzhou city in 2015 (KC15SM046), and the Youth Medical Talent Project of ‘Ke Jiao Qiang Wei Projects' in Jiangsu Province (QNRC2016375)
Notes on validation of instruments (screening and outcomes): validated questionnaires
Additional information: none
Handling the data: not applicable
Prospective trial registration number: Chinese Clinical Trials Registry (reference: ChiCTRIOP‐ 16008045)