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MBCGT and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient

Primary Purpose

Psychophysiologic Disorders, Stress, Psychological, Unipolar Depression

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mindfulness-based cognitive Group therapy
psycho-physiological stress regulation group
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Psychophysiologic Disorders focused on measuring Psychotherapy, Group

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Physical and mental condition caused by stress, physician diagnosed
  • suffered from major depression, in remission more than three months , and had moderate or mild depressed mood

Exclusion Criteria:

  • Suffering from schizophrenia or anxiety disorder .
  • Chronic diseases (such as diabetes, stroke, heart disease, cancer, etc.) or major injury (such as a car accident brain injury)

Sites / Locations

  • Department of Family Medicine, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

No Intervention

Arm Label

MBCT Group for stress patient

MBCT Group for depression patient

SR group for stress patient

SR group for depression patient

normal

Drug treatment remission patient

Arm Description

Mindfulness-based cognitive Group therapy will be administered on stress patient.

Mindfulness-based cognitive Group therapy will be administered on depression patient.

psycho-physiological stress regulation group will be administered on stress patient.

psycho-physiological stress regulation group will be administered on depression patients.

normal, no intervention.

Drug treatment remission patient

Outcomes

Primary Outcome Measures

scores change on the Beck Depression Inventory, physical and psychological symptom score, negative self-thinking scale, mental focus and self-monitoring Scale, and Awareness Scale.
Self-administered questionnaire were seven parts, including: Beck Depression Inventory, physical and psychological symptom score, negative self-thinking scale, mental focus and self-monitoring Scale, Awareness Scale

Secondary Outcome Measures

Full Information

First Posted
January 30, 2013
Last Updated
August 12, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01894932
Brief Title
MBCGT and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient
Official Title
Mindfulness-based Cognitive Group Therapy (MBCGT) and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient: An Outcome Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Cases of physical and psychological stress problems is the need to prevent the risk of depression, primary care model will help to prevent depression. Many scholars have advocated for depression treatment not only concern symptom control and relief, prevention of recurrence should also be aware. The literature found cases had depression, with cognitive strategy bias , may cause recurrence of depression, under the influence of stress. The study was to assist the physical and mental disorder patient caused by stress and depression patient having cognitive and emotional regulation, and increased adapting Ability by ongoing two separate treatment groups ,Mindfulness-based Cognitive Group Therapy and psycho-physiological stress regulation Group Therapy. In addition, psychological groups can also help regulation daily Trivia stress, study will try to know about how group therapy's effects on patient's immune system.Research has three purposes,to validation 2 group model's results in assisting psycho-physiological stressed and depression patient, to establish group leader training center and prepare groups' standard procedure manuals,and to understand the patient's psycho-physical stress reaction on the immune system and fat cell hormone.
Detailed Description
The study was to assist the physical and mental disorder patient caused by stress and depression patient having cognitive and emotional regulation, and increased adapting Ability by ongoing two separate treatment groups ,Mindfulness-based Cognitive Group Therapy and psycho-physiological stress regulation Group Therapy. In addition, psychological groups can also help regulation daily Trivia stress, study will try to know about how group therapy's effects on patient's immune system.Research has three purposes,to validation 2 group model's results in assisting psycho-physiological stressed and depression patient, to establish group leader training center and prepare groups' standard procedure manuals,and to understand the patient's psycho-physical stress reaction on the immune system and fat cell hormone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychophysiologic Disorders, Stress, Psychological, Unipolar Depression
Keywords
Psychotherapy, Group

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MBCT Group for stress patient
Arm Type
Experimental
Arm Description
Mindfulness-based cognitive Group therapy will be administered on stress patient.
Arm Title
MBCT Group for depression patient
Arm Type
Experimental
Arm Description
Mindfulness-based cognitive Group therapy will be administered on depression patient.
Arm Title
SR group for stress patient
Arm Type
Experimental
Arm Description
psycho-physiological stress regulation group will be administered on stress patient.
Arm Title
SR group for depression patient
Arm Type
Experimental
Arm Description
psycho-physiological stress regulation group will be administered on depression patients.
Arm Title
normal
Arm Type
No Intervention
Arm Description
normal, no intervention.
Arm Title
Drug treatment remission patient
Arm Type
No Intervention
Arm Description
Drug treatment remission patient
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based cognitive Group therapy
Intervention Description
In this study, groups of Mindfulness-based cognitive psychotherapy, will based on Segal, Williams & Teasdale (2002)'s work to redesigned an eight-week group course which adapted the local Taiwanese culture and add the appropriate revision of the content in a more easy to understand learning materials available to patient. The group would lead by 2 clinical psychologist and each session is about 2 hours.
Intervention Type
Behavioral
Intervention Name(s)
psycho-physiological stress regulation group
Intervention Description
Physical and psychological stress regulation group in eight weeks, mainly to provide understanding of physical and mental effects of stress factors, self-conceptualization of stress and psychosomatic symptoms, physiological adjustment (relaxation, diet, exercise), psychological adjustment (positive primary, secondary assessment, cognitive identification), adjust negative thoughts, learn coping by using new choice. The group would lead by 2 clinical psychologist and each session is about 2 hours.
Primary Outcome Measure Information:
Title
scores change on the Beck Depression Inventory, physical and psychological symptom score, negative self-thinking scale, mental focus and self-monitoring Scale, and Awareness Scale.
Description
Self-administered questionnaire were seven parts, including: Beck Depression Inventory, physical and psychological symptom score, negative self-thinking scale, mental focus and self-monitoring Scale, Awareness Scale
Time Frame
25 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Physical and mental condition caused by stress, physician diagnosed suffered from major depression, in remission more than three months , and had moderate or mild depressed mood Exclusion Criteria: Suffering from schizophrenia or anxiety disorder . Chronic diseases (such as diabetes, stroke, heart disease, cancer, etc.) or major injury (such as a car accident brain injury)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lue Bee-Horng, MD
Organizational Affiliation
Department of Family Medicine, National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Family Medicine, National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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MBCGT and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient

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