Web-Based Collaborative Care for Patients With Diabetes and Depression

NCT01985711 | Unknown

• 1 other identifier: WBCCFPWDAD
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Depression

Keywords

Motivational Interviewing; Cognitive Behavioral Therapy; Transtheoretical Model of behavior change; Questionnaires; Telemedicine/*methods; Comorbidity; Diabetes; Glucose/metabolism; Hemoglobin A, Glycosylated; Blood Pressure; Cholesterol, LDL/blood; Quality of life; Depressive Disorder/psychology/*therapy; Randomized Controlled Trials

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change in biochemical index

  Baseline, 3-month, 6-month, 9-month, 12-month

• Chang in quality of life (EuroQol-5D)score

  baseline, 3-month, 6-month,9-month, 12-month

• Change in Diabetes-specific stress

  Baseline, 3-month, 6-month,9-month, 12-month

• Change in Health behaviours

  Baseline, 3-month, 6-month, 9-month, 12-month

• Change in general self-efficacy

  Baseline, 3-month, 6-month, 9-month, 12-month

Study Arms (2)

web-based,CBT,MI,TTM, outpatient

EXPERIMENTAL

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.

Device: web-based collaborative care; Other: wait-list; Behavioral: usual diabetes outpatient care

waitlist, usual diabetes outpatient

OTHER

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.

Device: web-based collaborative care; Other: wait-list; Behavioral: usual diabetes outpatient care

Interventions

web-based collaborative care DEVICE

Firstly ,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months. Secondly, usual diabetes outpatient care for 6 months.

Also known as: multidisciplinary care

waitlist, usual diabetes outpatient; web-based,CBT,MI,TTM, outpatient

wait-list OTHER

Firstly ,usual diabetes outpatient care for 6 months. Secondly,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.

Also known as: usual diabetes outpatient care

waitlist, usual diabetes outpatient; web-based,CBT,MI,TTM, outpatient

usual diabetes outpatient care BEHAVIORAL

waitlist, usual diabetes outpatient; web-based,CBT,MI,TTM, outpatient

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Type 2 Diabetes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 010, China

Location

Related Publications (13)

• 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.

  PMID: 24002281 BACKGROUND

• 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.

  PMID: 22909306 BACKGROUND

• 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.

  PMID: 23087861 BACKGROUND

• 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.

  PMID: 11088090 BACKGROUND

• 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.

  PMID: 15745842 BACKGROUND

• 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.

  PMID: 15333477 BACKGROUND

• Prochaska, J.O., Transtheoretical Model of Behavior Change, in Encyclopedia of Behavioral Medicine. 2013, Springer. p. 1997--2000.

  BACKGROUND

• 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.

  PMID: 20423957 BACKGROUND

• 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.

  PMID: 16199119 BACKGROUND

• 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.

  PMID: 23870719 BACKGROUND

• 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.

  PMID: 20628129 BACKGROUND

• 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.

  PMID: 17492326 BACKGROUND

• 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.

  PMID: 21216855 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression; Diabetes Mellitus; Depressive Disorder

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Tao Hong

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huang Zhenru

CONTACT

13811558293

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: November 9, 2013
• First Posted: November 15, 2013
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: April 1, 2017
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

CN (1)