Minimal Psychological Intervention in Diabetes Patients
Primary Purpose
Diabetes Mellitus, Type 2, Depression
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minimal psychological intervention
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Type 2 diabetes, Minimal psychological intervention, Glycemic control, Depressive symptoms, Problem Area in Diabetes, Middle-aged and older adults, HbA1c protein, human
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Diabetes disease
Exclusion Criteria:
- Were using anti-depression medication
- With ongoing psychological/psychiatric treatment
- Had been diagnosed with psychosis (ex. schizophrenia or bipolar disorder)
- Had severe cognitive problem or hearing impairment
- Lost their partner within three months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Minimal Psychological Intervention
Usual care
Arm Description
Participants allocated to this group not only received the usual care as given by their family physicians, but also accepted biweekly minimal psychological intervention via telephone during six weeks.
Participants in this group received usual care only.
Outcomes
Primary Outcome Measures
Depressive symptom assessed by CES-D 10
Depressive symptom score was assessed with the 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10).
Diabetes-related distress assessed by PAID scale
Diabetes-specific emotional distress was assessed with the Problem Areas in Diabetes (PAID) scale.
Hemoglobin A1c
Secondary Outcome Measures
Full Information
NCT ID
NCT02473081
First Posted
June 9, 2015
Last Updated
June 11, 2015
Sponsor
National Cheng-Kung University Hospital
Collaborators
National Science Council, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02473081
Brief Title
Minimal Psychological Intervention in Diabetes Patients
Official Title
The Long-term Effect of a Minimal Psychological Intervention on Type 2 Diabetes Patients' Depressive Symptom, Diabetes-related Distress and Glycemic Control
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng-Kung University Hospital
Collaborators
National Science Council, Taiwan
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether the telephone-delivered Minimal Psychological Intervention (MPI) could improve diabetes' depressive symptom and diabetes-related immediately , as well as HbA1c level in the long-term.
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
Type 2 diabetes, Minimal psychological intervention, Glycemic control, Depressive symptoms, Problem Area in Diabetes, Middle-aged and older adults, HbA1c protein, human
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Minimal Psychological Intervention
Arm Type
Experimental
Arm Description
Participants allocated to this group not only received the usual care as given by their family physicians, but also accepted biweekly minimal psychological intervention via telephone during six weeks.
Arm Title
Usual care
Arm Type
Other
Arm Description
Participants in this group received usual care only.
Intervention Type
Behavioral
Intervention Name(s)
Minimal psychological intervention
Intervention Description
Minimal psychological intervention (MPI) was used to help adults with chronic illness to manage their psychological burden by breaking through a negative spiral between thoughts and behaviors.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care was given by their family physicians.
Primary Outcome Measure Information:
Title
Depressive symptom assessed by CES-D 10
Description
Depressive symptom score was assessed with the 10-item Center for Epidemiologic Studies Depression Scale (CES-D 10).
Time Frame
At three points in time: at baseline (wave 1), post-intervention or 6 weeks after randomization (wave 2), and 1 month after the intervention period or 10 weeks after randomization (wave 3)
Title
Diabetes-related distress assessed by PAID scale
Description
Diabetes-specific emotional distress was assessed with the Problem Areas in Diabetes (PAID) scale.
Time Frame
At three points in time: at baseline (wave 1), post-intervention or 6 weeks after randomization (wave 2), and 1 month after the intervention period or 10 weeks after randomization (wave 3)
Title
Hemoglobin A1c
Time Frame
Participants were measured during entire follow-up period, an average period of 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Diabetes disease
Exclusion Criteria:
Were using anti-depression medication
With ongoing psychological/psychiatric treatment
Had been diagnosed with psychosis (ex. schizophrenia or bipolar disorder)
Had severe cognitive problem or hearing impairment
Lost their partner within three months
12. IPD Sharing Statement
Learn more about this trial
Minimal Psychological Intervention in Diabetes Patients
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