Web-Based Collaborative Care for Patients With Diabetes and Depression

Depression Clinical Trial

— WBCC  

Official title:

Effects of a Web-Based Collaborative Care Management System (WBCCMS) on Psychosocial Outcomes and Biochemical Outcomes Among Patients With Diabetes and Depression

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01985711
• Other study ID #: WBCCFPWDAD
• Status: Not yet recruiting
• Phase: N/A
• First received: November 9, 2013
• Last updated: November 14, 2013
• Start date: May 2014
• Est. completion date: April 2017

Study information

• Verified date: November 2013
• Source: Beijing Anzhen Hospital
• Contact: Huang Zhenru
• Phone: 13811558293
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Science and Technology Commission
• Study type: Interventional

Clinical Trial Summary

The goal of this proposal is to integrate depression services and diabetes care methods into a web-based collaborative care system so that a single program can assist patients with diabetes and co-morbid depression. The investigators hypothesized that the effect of the intervention program on (a) decreasing depressive symptomatology; (b) improving biomedical outcomes (e.g., blood lipid profiles,blood glucose, glycosylated hemoglobin, and blood pressure). (c) Increasing healthful behavior (medicine compliance, physical activity, diabetic diet);(d)decreasing unhealthful behavior( sedentary activities, smoking, alcohol addiction); (e) improving quality of life.

Description:

Recent study shows that the overall prevalence of diabetes was estimated to be 11.6% (95% confidence interval, 11.3%-11.8%) in the Chinese adult population[1]. Depression is a common comorbidities in patients with diabetes with prevalence rates more than 30%[2, 3]. Co-morbid depression portends worse health outcomes (such as glycemic control, medication adherence, quality of life, physical activity, and blood pressure control，diabetic complication) and increases health care costs[4-6]. But the rate of diabetes-depression recognition and treatment is low. Collaborative primary care model, which involves a multidisciplinary health care team guiding patient-centered care , has been tested in the US and showed a significant reduction of depressive symptoms, improved diabetes care and patient-reported outcomes, and saved money. We aim to developing a web-based collaborative care system and compare the effectiveness of this new collaborative care model with usual diabetes outpatient care for patients with type 2 diabetes and depression in China.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• diagnosis of Type 2 Diabetes

• 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:

• inability to give informed consent

• 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Diabetes Mellitus, Type 2

Intervention

Device:
• 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.

Other:
• 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.

Behavioral:
• usual diabetes outpatient care

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital	Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

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. Epub 2005 Sep 30. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. Epub 2007 May 10. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire-9 items (PHQ-9) score	Depressive symptoms were measured using the nine-item Patient Health Questionnaire (PHQ-9).PHQ-9 scored on a range from 0 to 27, where lower scores represent fewer depressive symptoms.A remission of depression symptoms is indicated with a PHQ-9 score <10 for a period of three consecutive months.	baseline , 3-month, 6-month,9-month, 12-month	No
Secondary	Change in biochemical index	We will compare changes in hemoglobin A1c, blood glucose,blood lipids, and blood pressure levels between the immediate intervention group and the wait-list control group over time.Improvement is defined as 10% improvement over baseline.	Baseline, 3-month, 6-month, 9-month, 12-month	No
Secondary	Chang in quality of life (EuroQol-5D)score	The health-related quality of patients' life was rated with use of the quality-of-life EuroQol-5 Dimensions (EQ-5D)index.	baseline, 3-month, 6-month,9-month, 12-month	No
Secondary	Change in Diabetes-specific stress	Measured by Problem Areas In Diabetes 5-level questionnaire (PAID-5).	Baseline, 3-month, 6-month,9-month, 12-month	No
Secondary	Change in Health behaviours	We will assess of smoking behaviours,alcohol consumption, physical activity,and medication taking.	Baseline, 3-month, 6-month, 9-month, 12-month	No
Secondary	Change in general self-efficacy	General self-efficacy is measured by a widely used parsimonious ten-item scale called 'General Self-Efficacy Scale(GSES)',which was developed for use in several cultures.	Baseline, 3-month, 6-month, 9-month, 12-month	No