Community-based Cognitive Behavioral Therapy for Type 2 Diabetes
NCT ID: NCT04261361
Last Updated: 2023-06-07
Study Results
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Basic Information
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COMPLETED
NA
168 participants
INTERVENTIONAL
2018-12-12
2022-05-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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CBCBT intervention
1. Adherence counseling
2. Psycho-education package
3. 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.
CBCBT intervention
8 group CBT sessions and 4 weekly follow-up calls
Adherence counseling
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
Printed materials of a DM self-management education program will be delivered to both the CBCBT and ETAU groups.
enhanced treatment as usual (ETAU)
1. Adherence counseling;
2. Psycho-education package;
3. To maintain some control over the contact time, we will give them 4 bi-weekly individual phone calls of about 10 minutes each while the CBCBT intervention group is having their 8 weeks of face-to-face group sessions.
Adherence counseling
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
Printed materials of a DM self-management education program will be delivered to both the CBCBT and ETAU groups.
Interventions
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CBCBT intervention
8 group CBT sessions and 4 weekly follow-up calls
Adherence counseling
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
Printed materials of a DM self-management education program will be delivered to both the CBCBT and ETAU groups.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
25 Years
60 Years
ALL
No
Sponsors
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The Hong Kong Polytechnic University
OTHER
Responsible Party
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Dr. Au May-lan Alma
Associate Professor
Principal Investigators
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Alma Au, PhD
Role: PRINCIPAL_INVESTIGATOR
Applied Social Sciences, Hong Kong Polytechnic University
Locations
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Applied Social Sciences, Hong Kong Polytechnic University
Hong Kong, , Hong Kong
Institute of Active Ageing
Kowloon, , Hong Kong
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HMRFCBCBT
Identifier Type: -
Identifier Source: org_study_id
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