NCT01894932

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 14, 2013

Status Verified

July 1, 2013

Enrollment Period

5.3 years

First QC Date

January 30, 2013

Last Update Submit

August 12, 2013

Conditions

Keywords

Psychotherapy, Group

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

MBCT Group for stress patient

EXPERIMENTAL

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

Behavioral: Mindfulness-based cognitive Group therapy

MBCT Group for depression patient

EXPERIMENTAL

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

Behavioral: Mindfulness-based cognitive Group therapy

SR group for stress patient

EXPERIMENTAL

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

Behavioral: psycho-physiological stress regulation group

SR group for depression patient

EXPERIMENTAL

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

Behavioral: psycho-physiological stress regulation group

normal

NO INTERVENTION

normal, no intervention.

Drug treatment remission patient

NO INTERVENTION

Drug treatment remission patient

Interventions

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.

MBCT Group for depression patientMBCT Group for 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.

SR group for depression patientSR group for stress patient

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family Medicine, National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Psychophysiologic DisordersStress, PsychologicalDepressive Disorder

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMood DisordersMental Disorders

Study Officials

  • Lue Bee-Horng, MD

    Department of Family Medicine, National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

July 10, 2013

Study Start

April 1, 2011

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

August 14, 2013

Record last verified: 2013-07

Locations