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

Primary Purpose

Diabetes Mellitus, Type 2, Depression

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
web-based collaborative care
wait-list
usual diabetes outpatient care
Sponsored by
Beijing Anzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Anzhen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

web-based,CBT,MI,TTM, outpatient

waitlist, usual diabetes outpatient

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Change in Diabetes-specific stress
Measured by Problem Areas In Diabetes 5-level questionnaire (PAID-5).
Change in Health behaviours
We will assess of smoking behaviours,alcohol consumption, physical activity,and medication taking.
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.

Full Information

First Posted
November 9, 2013
Last Updated
November 14, 2013
Sponsor
Beijing Anzhen Hospital
Collaborators
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01985711
Brief Title
Web-Based Collaborative Care for Patients With Diabetes and Depression
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
Collaborators
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
web-based,CBT,MI,TTM, outpatient
Arm Type
Experimental
Arm Description
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.
Arm Title
waitlist, usual diabetes outpatient
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
web-based collaborative care
Other Intervention Name(s)
multidisciplinary care
Intervention Description
Firstly ,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months. Secondly, usual diabetes outpatient care for 6 months.
Intervention Type
Other
Intervention Name(s)
wait-list
Other Intervention Name(s)
usual diabetes outpatient care
Intervention Description
Firstly ,usual diabetes outpatient care for 6 months. Secondly,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
Intervention Type
Behavioral
Intervention Name(s)
usual diabetes outpatient care
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 items (PHQ-9) score
Description
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.
Time Frame
baseline , 3-month, 6-month,9-month, 12-month
Secondary Outcome Measure Information:
Title
Change in biochemical index
Description
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.
Time Frame
Baseline, 3-month, 6-month, 9-month, 12-month
Title
Chang in quality of life (EuroQol-5D)score
Description
The health-related quality of patients' life was rated with use of the quality-of-life EuroQol-5 Dimensions (EQ-5D)index.
Time Frame
baseline, 3-month, 6-month,9-month, 12-month
Title
Change in Diabetes-specific stress
Description
Measured by Problem Areas In Diabetes 5-level questionnaire (PAID-5).
Time Frame
Baseline, 3-month, 6-month,9-month, 12-month
Title
Change in Health behaviours
Description
We will assess of smoking behaviours,alcohol consumption, physical activity,and medication taking.
Time Frame
Baseline, 3-month, 6-month, 9-month, 12-month
Title
Change in general self-efficacy
Description
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.
Time Frame
Baseline, 3-month, 6-month, 9-month, 12-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Zhenru
Phone
13811558293
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Hong
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
010
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huang Zhenru

12. IPD Sharing Statement

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Web-Based Collaborative Care for Patients With Diabetes and Depression

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