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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
National Cheng-Kung University 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 Type 2 diabetes, Minimal psychological intervention, Glycemic control, Depressive symptoms, Problem Area in Diabetes, Middle-aged and older adults, HbA1c protein, human

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 9, 2015
    Last Updated
    June 11, 2015
    Sponsor
    National Cheng-Kung University Hospital
    Collaborators
    National Science Council, Taiwan
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    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

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    Minimal Psychological Intervention in Diabetes Patients

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