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Objectives: The aim of the study is evaluate the efficacy of a telephone assisted cognitive behavioral therapy for adherence (CBCBT) in type 2 diabetes.
Hypothesis: CBCBT will primarily reduce depressive symptoms and improve glycemic control and secondarily, improve adherence and self-care and reduce diabetes-specific distress.
Design and subjects: This is a prospective randomized two-armed intervention study. One hundred sixty eight participants will be recruited from five sites covering the following clusters: New Territories East, Kowloon East and Hong Kong West.
Intervention: The CBT protocol (Safren et al., 2013) will be used in the intervention. Specific components include: 1) introducing CBT for behavior change, 2) increasing pleasurable activities and mood monitoring, 3) cognitive restructuring, 4) problem-solving in self-care and 5) relaxation training. To maximize accessibility, eight sessions will be delivered face-to-face in group setting and the other four sessions will be delivered by telephone. Three monthly follow-up telephone calls will be made to consolidate treatment gains.
Main outcome measures: Primary outcomes include the Beck Depression Inventory and glycemic control. Secondary outcomes include self-care and diabetes-specific distress.
Data analysis: Treatment outcomes will be assessed by Repeated Measures ANOVA and also Intention to Treat Analysis. Regression models will be used to estimate effect sizes and associations among variables.
Expected results: CBCBT would significantly reduce depressive symptoms and improve glycemic control. With secondary outcomes, CBCBT will improve self-care and reduce diabetes-specific distress.
A community-based CBCBT is tested for patients living with diabetes(DM) and subclinical depression. The program includes both face-to-face group sessions and individual telephone sessions. The aim of the current study is to evaluate the efficacy of a mixed mode CBCBT in reducing depressive symptoms and enhancing adherence among adults with DM and subclinical depression. The intervention program consists of three components: 1) eight weekly sessions of face-to-face interventions, 2) four weekly consolidation individual telephone calls and 3) three monthly individual follow-up phone calls.
This is a prospective randomized two-armed intervention study. The CBCBT intervention will be compared with enhanced treatments usual (ETAU) using a single blinded randomized design. The intervention will be delivered by qualified health care professional (e.g. clinical psychology/ social worker/ nurse counsellor) who have had some training in CBCBT in the initial training.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBCBT intervention | Experimental |
|
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| enhanced treatment as usual (ETAU) | Active Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBCBT intervention | Behavioral | 8 group CBT sessions and 4 weekly follow-up calls |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms | The Beck Depression Inventory (BDI-I) assesses cognitive, behavioral and somatic symptoms of depression. | Change from baseline through study completion, an average of 24 weeks |
| Glycemic control | Glycated haemoglobin (HbA1c) is used to measure glycemic control | Change from baseline through study completion, an average of 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Summary of DM Self-care Activities Questionnaire (SDSCA) | The revised 11-item SDSCA assess aspects of diabetes self-management that includes diet, exercise, self-monitoring of blood-glucose, foot care, and smoking in the past 7 days (0-7 points) by self-reported frequency. | Change from baseline through study completion, an average of 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alma Au, PhD | Applied Social Sciences, Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Social Sciences, Hong Kong Polytechnic University | Hong Kong | Hong Kong | ||||
| Institute of Active Ageing |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15111522 | Background | Goldney RD, Phillips PJ, Fisher LJ, Wilson DH. Diabetes, depression, and quality of life: a population study. Diabetes Care. 2004 May;27(5):1066-70. doi: 10.2337/diacare.27.5.1066. | |
| 17054590 | Background | Ali S, Stone MA, Peters JL, Davies MJ, Khunti K. The prevalence of co-morbid depression in adults with Type 2 diabetes: a systematic review and meta-analysis. Diabet Med. 2006 Nov;23(11):1165-73. doi: 10.1111/j.1464-5491.2006.01943.x. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Adherence counseling | Behavioral | All participants in both CBCBT and ETAU groups will have one session of Life-Steps, a stand-alone CBCBT intervention designed to improve adherence to medical recommendations and individualized DM self-management goals. |
|
| Psycho-education package | Behavioral | Printed materials of a DM self-management education program will be delivered to both the CBCBT and ETAU groups. |
|
| DM-specific distress | The DM Distress Scale (DDS) is a 17-item self-administered questionnaire identifying four domains of DM-related distress: emotional burden, physician-related distress, regimen related distress, and interpersonal distress | Change from baseline through study completion, an average of 24 weeks |
| Kowloon |
| Hong Kong |
| 25110840 | Background | Gonzalez JS, Shreck E, Psaros C, Safren SA. Distress and type 2 diabetes-treatment adherence: A mediating role for perceived control. Health Psychol. 2015 May;34(5):505-13. doi: 10.1037/hea0000131. Epub 2014 Aug 11. |
| 24774351 | Background | Cully JA, Breland JY, Robertson S, Utech AE, Hundt N, Kunik ME, Petersen NJ, Masozera N, Rao R, Naik AD. Behavioral health coaching for rural veterans with diabetes and depression: a patient randomized effectiveness implementation trial. BMC Health Serv Res. 2014 Apr 28;14:191. doi: 10.1186/1472-6963-14-191. |
| 16414426 | Background | Glasgow RE, Nelson CC, Strycker LA, King DK. Using RE-AIM metrics to evaluate diabetes self-management support interventions. Am J Prev Med. 2006 Jan;30(1):67-73. doi: 10.1016/j.amepre.2005.08.037. |
| Background | Nan H, Au A, Sum R, et al. Effect of family support intervention in diabetic retinopathy with depressive symptoms: a randomized clinical trial in Hong Kong. The 10th International Diabetes Federation-Western Pacific Congress. Suntec Singapore: International Diabetes Federation-Western Pacific Congress, 2014:ABS-1807. |
| 23938133 | Background | Zhang Y, Ting R, Lam M, Lam J, Nan H, Yeung R, Yang W, Ji L, Weng J, Wing YK, Sartorius N, Chan JCN. Measuring depressive symptoms using the Patient Health Questionnaire-9 in Hong Kong Chinese subjects with type 2 diabetes. J Affect Disord. 2013 Nov;151(2):660-666. doi: 10.1016/j.jad.2013.07.014. Epub 2013 Jul 31. |
| 25848237 | Background | Au A, Gallagher-Thompson D, Wong MK, Leung J, Chan WC, Chan CC, Lu HJ, Lai MK, Chan K. Behavioral activation for dementia caregivers: scheduling pleasant events and enhancing communications. Clin Interv Aging. 2015 Mar 26;10:611-9. doi: 10.2147/CIA.S72348. eCollection 2015. |
| 16443871 | Background | Katon W, Unutzer J, Fan MY, Williams JW Jr, Schoenbaum M, Lin EH, Hunkeler EM. Cost-effectiveness and net benefit of enhanced treatment of depression for older adults with diabetes and depression. Diabetes Care. 2006 Feb;29(2):265-70. doi: 10.2337/diacare.29.02.06.dc05-1572. |
| 17725179 | Background | Chan BS, Tsang MW, Lee VW, Lee KK. Cost of Type 2 Diabetes mellitus in Hong Kong Chinese. Int J Clin Pharmacol Ther. 2007 Aug;45(8):455-68. doi: 10.5414/cpp45455. |
| 23280258 | Background | Hermanns N, Caputo S, Dzida G, Khunti K, Meneghini LF, Snoek F. Screening, evaluation and management of depression in people with diabetes in primary care. Prim Care Diabetes. 2013 Apr;7(1):1-10. doi: 10.1016/j.pcd.2012.11.002. Epub 2012 Dec 30. |
| 24170758 | Result | Safren SA, Gonzalez JS, Wexler DJ, Psaros C, Delahanty LM, Blashill AJ, Margolina AI, Cagliero E. A randomized controlled trial of cognitive behavioral therapy for adherence and depression (CBT-AD) in patients with uncontrolled type 2 diabetes. Diabetes Care. 2014;37(3):625-33. doi: 10.2337/dc13-0816. Epub 2013 Oct 29. |
| D004700 | Endocrine System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |