Web-Based Collaborative Care for Patients With Diabetes and Depression
NCT ID: NCT01985711
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2014-05-31
2017-04-30
Brief Summary
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Detailed Description
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The web-based collaborative care system integrates usual management plan of diabetes and established theories for treating depression and diabetes specific behaviors or affective disorders. Diabetes management plan consists of a meal plan, exercise guidance, oral medications or insulin guidance, health education, supervision and regular blood glucose monitoring. Three main established theories of psychology as follows: 1) Cognitive Behavioral Therapy (CBT); 2) Transtheoretical Model（TTM）of Behavior Change\[7\]; and 3) Motivational interviewing(MI)\[8\]. Cognitive behavioral therapy helps people learn to change inappropriate or negative thought patterns and behaviors associated with the illness. Web-based CBT is generally viewed as a very effective form of psychotherapy for treating depression\[9-12\], which is also effective to manage diabetic stress\[13\]. Transtheoretical Model of Behavior Change and Motivational interviewing are both evidence-based behavior change techniques to improve diabetes and depression associated healthy behavior (such as taking medicine, physical activity, diabetic diet, drug therapy compliance) and to decrease unhealthy behavior(such as sedentary activities, smoking, alcohol addiction).The intervention will be conducted in a safety-net health system primary care setting.
A randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of culturally adapted diabetes and depression collaborative treatment for reducing depressive symptoms, activating diabetes healthy behaviors, decreasing unhealthy behaviors and improving adherence to diabetes self-care regimens in Chinese with depression and diabetes. Participation in this study will last 12 months. All participants will firstly undergo baseline assessments that will include a 40-minute interview about personal health and feelings. Eligible participants will then be assigned randomly to receive either web-based collaborative care or wait-list. Participants in web-based collaborative care group will receive 24 weekly 40-minute web-based Cognitive Behavioral Therapy (CBT) sessions, undergo structured Transtheoretical Model of Behavior Change or Motivational interviewing to set up proper life-style and healthy behavior to improve their live quality，conducted on the web. Besides, they will receive usual diabetes outpatient care and web-based diabetes care. Participants assigned to the wait-list group will be given usual diabetes outpatient service (diabetic medication guidance and appointment to see doctor as routine, without specific anti-depression therapy). After 6 months, they will receive web-based collaborative care for 6 months too. All participants receiving web-based collaborative care management will also receive supportive patient navigation services and maintenance/relapse telephone monitoring, their assistants (family member; online systems nurse, psychiatrists and endocrinologist) monitor and help them change their behaviors. All participants will undergo follow-up on-site interviews about their status at months 3, 6, 9 and12.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
SINGLE
Study Groups
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web-based,CBT,MI,TTM, outpatient
Participants in web-based collaborative care group will receive 24 weekly 40-minute web-based Cognitive Behavioral Therapy (CBT) sessions, undergo structured Transtheoretical Model of Behavior Change or Motivational interviewing to set up proper life-style and healthy behavior to improve their live quality，conducted on the web. Besides, they will receive usual diabetes outpatient care and web-based diabetes care.
web-based collaborative care
Firstly ,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
Secondly, usual diabetes outpatient care for 6 months.
wait-list
Firstly ,usual diabetes outpatient care for 6 months. Secondly,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
usual diabetes outpatient care
waitlist, usual diabetes outpatient
Participants assigned to the wait-list group will be given usual diabetes outpatient service (diabetic medication guidance and appointment to see doctor as routine, without specific anti-depression therapy). After 6 months, they will receive web-based collaborative care for 6 months too.
web-based collaborative care
Firstly ,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
Secondly, usual diabetes outpatient care for 6 months.
wait-list
Firstly ,usual diabetes outpatient care for 6 months. Secondly,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
usual diabetes outpatient care
Interventions
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web-based collaborative care
Firstly ,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
Secondly, usual diabetes outpatient care for 6 months.
wait-list
Firstly ,usual diabetes outpatient care for 6 months. Secondly,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
usual diabetes outpatient care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years and older
* be able to surf the internet at least once per week
* willing to give informed consent
* Score \>=10 on the PHQ-9
Exclusion Criteria
* Already receiving antidepressant treatment(medicine,CBT,et.)
* unwillingness or inability to use the web-based Collaborative Care System.
* Severe and/or terminal physical illness
* Pregnant or breastfeeding
* severe psychiatric disorders (psychotic disorder, major depression and so on) or suicidal tendencies
* Likely to have difficulty completing the forms and questionnaires
18 Years
70 Years
ALL
No
Sponsors
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Chinese PLA General Hospital
OTHER
Beijing Anzhen Hospital
OTHER
Responsible Party
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Tao Hong
PHD
Principal Investigators
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Tao Hong
Role: PRINCIPAL_INVESTIGATOR
Beijing Anzhen Hospital
Locations
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Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Huang Zhenru
Role: CONTACT
Phone: 13811558293
References
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Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
Roy T, Lloyd CE, Parvin M, Mohiuddin KG, Rahman M. Prevalence of co-morbid depression in out-patients with type 2 diabetes mellitus in Bangladesh. BMC Psychiatry. 2012 Aug 22;12:123. doi: 10.1186/1471-244X-12-123.
Mathew CS, Dominic M, Isaac R, Jacob JJ. Prevalence of depression in consecutive patients with type 2 diabetes mellitus of 5-year duration and its impact on glycemic control. Indian J Endocrinol Metab. 2012 Sep;16(5):764-8. doi: 10.4103/2230-8210.100671.
Ciechanowski PS, Katon WJ, Russo JE. Depression and diabetes: impact of depressive symptoms on adherence, function, and costs. Arch Intern Med. 2000 Nov 27;160(21):3278-85. doi: 10.1001/archinte.160.21.3278.
Lustman PJ, Clouse RE. Depression in diabetic patients: the relationship between mood and glycemic control. J Diabetes Complications. 2005 Mar-Apr;19(2):113-22. doi: 10.1016/j.jdiacomp.2004.01.002.
Lin EH, Katon W, Von Korff M, Rutter C, Simon GE, Oliver M, Ciechanowski P, Ludman EJ, Bush T, Young B. Relationship of depression and diabetes self-care, medication adherence, and preventive care. Diabetes Care. 2004 Sep;27(9):2154-60. doi: 10.2337/diacare.27.9.2154.
Prochaska, J.O., Transtheoretical Model of Behavior Change, in Encyclopedia of Behavioral Medicine. 2013, Springer. p. 1997--2000.
Rollnick S, Butler CC, Kinnersley P, Gregory J, Mash B. Motivational interviewing. BMJ. 2010 Apr 27;340:c1900. doi: 10.1136/bmj.c1900. No abstract available.
Butler AC, Chapman JE, Forman EM, Beck AT. The empirical status of cognitive-behavioral therapy: a review of meta-analyses. Clin Psychol Rev. 2006 Jan;26(1):17-31. doi: 10.1016/j.cpr.2005.07.003. Epub 2005 Sep 30.
Cuijpers P, Berking M, Andersson G, Quigley L, Kleiboer A, Dobson KS. A meta-analysis of cognitive-behavioural therapy for adult depression, alone and in comparison with other treatments. Can J Psychiatry. 2013 Jul;58(7):376-85. doi: 10.1177/070674371305800702.
Kroenke K, Theobald D, Wu J, Norton K, Morrison G, Carpenter J, Tu W. Effect of telecare management on pain and depression in patients with cancer: a randomized trial. JAMA. 2010 Jul 14;304(2):163-71. doi: 10.1001/jama.2010.944.
Fortney JC, Pyne JM, Edlund MJ, Williams DK, Robinson DE, Mittal D, Henderson KL. A randomized trial of telemedicine-based collaborative care for depression. J Gen Intern Med. 2007 Aug;22(8):1086-93. doi: 10.1007/s11606-007-0201-9. Epub 2007 May 10.
van Bastelaar KM, Pouwer F, Cuijpers P, Riper H, Snoek FJ. Web-based depression treatment for type 1 and type 2 diabetic patients: a randomized, controlled trial. Diabetes Care. 2011 Feb;34(2):320-5. doi: 10.2337/dc10-1248. Epub 2011 Jan 7.
Other Identifiers
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WBCCFPWDAD
Identifier Type: -
Identifier Source: org_study_id