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Effects of Cognitive-Oriented Intervention on Major Depressive Disorder

Primary Purpose

Mental Health Issue

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive-oriented intervention program
health education activities program
Sponsored by
Mackay Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Health Issue focused on measuring major depressive disorder, cognitive-oriented intervention

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Diagnosed with MDD by a psychiatrist, over 20 years of age, able to speak Mandarin or Taiwanese and able to write.

Exclusion Criteria: Patients who were diagnosed with other psychiatric disorders, with severe cognitive impairment or who could not make conversation acceptably were excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    cognitive-oriented intervention program

    received health education program

    Arm Description

    The intervention group received a 40 mins social support intervention program once a week lasting for 6 weeks. All participants were assessed by questionnaires before and after the intervention.

    The control group received health education activities with the same frequency as the intervention group. All participants were assessed by questionnaires before and after the intervention.

    Outcomes

    Primary Outcome Measures

    the Chinese Version of the Multidimensional Scale of Perceived Social Support (MSPSS)
    The MSPSS was developed by Zimet, Dahlem, Zimet and Farley (1988). It contains 12 questions, with four questions in each of three categories: (1) support from a significant other (significant other subscale); (2) support from family (family subscale); and (3) support from friends (friend subscale). This study adopts the Chinese version of the social support scale translated by Wang (2008). The higher the scale score meant the higher the perceived level of social support.
    the Coping Orientations to Problems Experienced (COPE) inventory
    The is a four-point scale with a total of 60 questions, including 14 subscales, which include active coping, planning, and suppression of competing activities, restraint, and use of instrumental social support, and humor are tend to problem-focused coping. The higher the score, the more often the response strategy is adopted.
    The Chinese version of the Beck Depression Inventory-II (BDI-II)
    The BDI-II has 21 questions. Higher scores indicated a greater degree of depression.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2022
    Last Updated
    March 16, 2022
    Sponsor
    Mackay Medical College
    Collaborators
    National Defense Medical Center, Taiwan, Tri-Service General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05296174
    Brief Title
    Effects of Cognitive-Oriented Intervention on Major Depressive Disorder
    Official Title
    Effects of Cognitive-Oriented Intervention on Perceived Social Support, Depression Symptoms, and Stress-coping Strategies in Patients With Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 31, 2016 (Actual)
    Primary Completion Date
    July 1, 2018 (Actual)
    Study Completion Date
    July 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mackay Medical College
    Collaborators
    National Defense Medical Center, Taiwan, Tri-Service General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The specific aims of the study were to explore the effects of the cognitive-oriented intervention program for promoting social support on perceived social supports, depression symptoms, and stress-coping strategies for patients with major depressive disorder in Taiwan.
    Detailed Description
    Background: Based on the 2010 World Health Organization declaration, depression will be ranked second among the global disease burden by 2020, second only to cardiovascular disease. It has become a disease that incurs high personal and social costs, and thus warrants considerable concern regarding its mitigation and early prevention. Purpose: The specific aims of the study were to explore the effects of the cognitive-oriented intervention program for promoting social support on perceived social supports, depression symptoms, and stress-coping strategies for patients with major depressive disorder in Taiwan. Method: This study adopted a randomized controlled trial (RCT). Patients with major depressive disorder were recruited from acute psychiatric wards in a medical center in Northern Taiwan. The study was conducted from July 1, 2015, to December 31, 2016; 105 patients met the inclusion criteria, and 100 patients agreed to participate in the study and completed the evaluation. The participants were randomly assigned to intervention group or control group. The intervention group received a 40 mins social support intervention program once a week lasting for 6 weeks, and the control group received health education activities with the same frequency as the intervention group. All participants were assessed by questionnaires before and after the intervention. Statistical analyses were performed by using descriptive statistics, independent sample t tests, and linear multiple regression analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Health Issue
    Keywords
    major depressive disorder, cognitive-oriented intervention

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    105 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    cognitive-oriented intervention program
    Arm Type
    Experimental
    Arm Description
    The intervention group received a 40 mins social support intervention program once a week lasting for 6 weeks. All participants were assessed by questionnaires before and after the intervention.
    Arm Title
    received health education program
    Arm Type
    Active Comparator
    Arm Description
    The control group received health education activities with the same frequency as the intervention group. All participants were assessed by questionnaires before and after the intervention.
    Intervention Type
    Other
    Intervention Name(s)
    cognitive-oriented intervention program
    Intervention Description
    The experimental group was offered six 40-minute courses once a week.
    Intervention Type
    Other
    Intervention Name(s)
    health education activities program
    Intervention Description
    The control group was offered health education activities once a week.
    Primary Outcome Measure Information:
    Title
    the Chinese Version of the Multidimensional Scale of Perceived Social Support (MSPSS)
    Description
    The MSPSS was developed by Zimet, Dahlem, Zimet and Farley (1988). It contains 12 questions, with four questions in each of three categories: (1) support from a significant other (significant other subscale); (2) support from family (family subscale); and (3) support from friends (friend subscale). This study adopts the Chinese version of the social support scale translated by Wang (2008). The higher the scale score meant the higher the perceived level of social support.
    Time Frame
    before the intervention to 6 weeks (after the intervention)
    Title
    the Coping Orientations to Problems Experienced (COPE) inventory
    Description
    The is a four-point scale with a total of 60 questions, including 14 subscales, which include active coping, planning, and suppression of competing activities, restraint, and use of instrumental social support, and humor are tend to problem-focused coping. The higher the score, the more often the response strategy is adopted.
    Time Frame
    before the intervention to 6 weeks (after the intervention)
    Title
    The Chinese version of the Beck Depression Inventory-II (BDI-II)
    Description
    The BDI-II has 21 questions. Higher scores indicated a greater degree of depression.
    Time Frame
    before the intervention to 6 weeks (after the intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:Diagnosed with MDD by a psychiatrist, over 20 years of age, able to speak Mandarin or Taiwanese and able to write. Exclusion Criteria: Patients who were diagnosed with other psychiatric disorders, with severe cognitive impairment or who could not make conversation acceptably were excluded.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shu-Li Cheng, PhD
    Organizational Affiliation
    Department of Nursing, Mackay Medical College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Cognitive-Oriented Intervention on Major Depressive Disorder

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