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

Stress, Psychological Clinical Trial

Official title:

Mindfulness-based Cognitive Group Therapy (MBCGT) and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient: An Outcome Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01894932
• Other study ID #: 201103042RC
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 30, 2013
• Last updated: August 12, 2013
• Start date: April 2011
• Est. completion date: August 2016

Study information

• Verified date: July 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Psychophysiologic Disorders
• Stress, Psychological
• Unipolar Depression

Intervention

Behavioral:
• Mindfulness-based cognitive Group therapy
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.
• psycho-physiological stress regulation group
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.

Locations

Country	Name	City	State
Taiwan	Department of Family Medicine, National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	25 weeks	No