Web-Based Collaborative Care for Patients With Diabetes and Depression (WBCC)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Beijing Anzhen Hospital
Sponsor:
Collaborator:
Chinese PLA General Hospital
Information provided by (Responsible Party):
Tao Hong, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT01985711
First received: November 9, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Depression
Device: web-based collaborative care
Other: wait-list
Behavioral: usual diabetes outpatient care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of a Web-Based Collaborative Care Management System (WBCCMS) on Psychosocial Outcomes and Biochemical Outcomes Among Patients With Diabetes and Depression

Resource links provided by NLM:


Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:
  • Change in Patient Health Questionnaire-9 items (PHQ-9) score [ Time Frame: baseline , 3-month, 6-month,9-month, 12-month ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in biochemical index [ Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month ] [ Designated as safety issue: No ]
    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.

  • Chang in quality of life (EuroQol-5D)score [ Time Frame: baseline, 3-month, 6-month,9-month, 12-month ] [ Designated as safety issue: No ]
    The health-related quality of patients' life was rated with use of the quality-of-life EuroQol-5 Dimensions (EQ-5D)index.

  • Change in Diabetes-specific stress [ Time Frame: Baseline, 3-month, 6-month,9-month, 12-month ] [ Designated as safety issue: No ]
    Measured by Problem Areas In Diabetes 5-level questionnaire (PAID-5).

  • Change in Health behaviours [ Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month ] [ Designated as safety issue: No ]
    We will assess of smoking behaviours,alcohol consumption, physical activity,and medication taking.

  • Change in general self-efficacy [ Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: May 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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 Name: multidisciplinary care
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.
Other Name: usual diabetes outpatient care
Behavioral: 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.
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 Name: multidisciplinary care
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.
Other Name: usual diabetes outpatient care
Behavioral: usual diabetes outpatient care

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985711

Contacts
Contact: Huang Zhenru 13811558293

Locations
China, Beijing
Beijing Anzhen Hospital Not yet recruiting
Beijing, Beijing, China, 010
Sub-Investigator: Huang Zhenru         
Sponsors and Collaborators
Beijing Anzhen Hospital
Chinese PLA General Hospital
Investigators
Principal Investigator: Tao Hong Beijing Anzhen Hospital
  More Information

Publications:
Responsible Party: Tao Hong, PHD, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01985711     History of Changes
Other Study ID Numbers: WBCCFPWDAD
Study First Received: November 9, 2013
Last Updated: November 14, 2013
Health Authority: China: Beijing Municipal Science and Technology Commission

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Diabetes Mellitus
Diabetes Mellitus, Type 2
Behavioral Symptoms
Mood Disorders
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 24, 2014