- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01894932
MBCGT and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient
August 12, 2013 updated by: National Taiwan University Hospital
Mindfulness-based Cognitive Group Therapy (MBCGT) and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient: An Outcome Study
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.
Study Overview
Status
Unknown
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.
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- Department of Family Medicine, National Taiwan University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MBCT Group for stress patient
Mindfulness-based cognitive Group therapy will be administered on stress patient.
|
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.
|
EXPERIMENTAL: MBCT Group for depression patient
Mindfulness-based cognitive Group therapy will be administered on depression patient.
|
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.
|
EXPERIMENTAL: SR group for stress patient
psycho-physiological stress regulation group will be administered on stress patient.
|
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.
|
EXPERIMENTAL: SR group for depression patient
psycho-physiological stress regulation group will be administered on depression patients.
|
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.
|
NO_INTERVENTION: normal
normal, no intervention.
|
|
NO_INTERVENTION: Drug treatment remission patient
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 25 weeks
|
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
|
25 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Lue Bee-Horng, MD, Department of Family Medicine, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (ANTICIPATED)
July 1, 2016
Study Completion (ANTICIPATED)
August 1, 2016
Study Registration Dates
First Submitted
January 30, 2013
First Submitted That Met QC Criteria
July 4, 2013
First Posted (ESTIMATE)
July 10, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
August 14, 2013
Last Update Submitted That Met QC Criteria
August 12, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201103042RC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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