Psychophysiologic DisordersNCT01894932
MBCGT and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient
A study testing Mindfulness-based cognitive Group therapy and psycho-physiological stress regulation group in people with Psychophysiologic Disorders and Stress, Psychological, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychophysiologic Disorders, Stress, Psychological, Unipolar Depression
- What is being tested?
- Mindfulness-based cognitive Group therapy and psycho-physiological stress regulation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Family Medicine, National Taiwan University Hospital
Taipei, Taiwan, 100
About this study
Official title: 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.
Read the 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.
- Being tested
- Mindfulness-based cognitive Group therapy, psycho-physiological stress regulation group
- Keywords
- Psychotherapy, Group
- Medical subject headings
- Psychophysiologic Disorders, Stress, Psychological, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based cognitive Group therapyBehavioural
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 groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| MBCT Group for stress patient | Experimental | Mindfulness-based cognitive Group therapy will be administered on stress patient. Receives: Behavioral: Mindfulness-based cognitive Group therapy |
| MBCT Group for depression patient | Experimental | Mindfulness-based cognitive Group therapy will be administered on depression patient. Receives: Behavioral: Mindfulness-based cognitive Group therapy |
| SR group for stress patient | Experimental | psycho-physiological stress regulation group will be administered on stress patient. Receives: Behavioral: psycho-physiological stress regulation group |
| SR group for depression patient | Experimental | psycho-physiological stress regulation group will be administered on depression patients. Receives: Behavioral: psycho-physiological stress regulation group |
| normal | No intervention | normal, no intervention. |
| Drug treatment remission patient | No intervention | Drug treatment remission patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startApr 2011
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychophysiologic DisordersStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lue Bee-Horng, MD, Study director, Department of Family Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894932
- Sponsor's protocol ID
- 201103042RC
- Status last verified
- Jul 2013
- First submitted
- 30 Jan 2013
- Last updated
- 14 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Cognitive Group Therapy (MBCGT) and Psycho-physiological Stress Regulation Group for Depression and Psycho-physiological Stress Patient: An Outcome Study
- ClinicalTrials.gov ID
- NCT01894932
- Acronym / sponsor ID
- 201103042RC
- Keywords
- Psychotherapy, Group
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 10 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MBCT Group for stress patient | Experimental | Behavioral: Mindfulness-based cognitive Group therapyMindfulness-based cognitive Group therapy will be administered on stress patient. |
| MBCT Group for depression patient | Experimental | Behavioral: Mindfulness-based cognitive Group therapyMindfulness-based cognitive Group therapy will be administered on depression patient. |
| SR group for stress patient | Experimental | Behavioral: psycho-physiological stress regulation grouppsycho-physiological stress regulation group will be administered on stress patient. |
| SR group for depression patient | Experimental | Behavioral: psycho-physiological stress regulation grouppsycho-physiological stress regulation group will be administered on depression patients. |
| normal | No intervention | –normal, no intervention. |
| Drug treatment remission patient | No intervention | –Drug treatment remission patient |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based cognitive Group therapyIn 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. | Behavioural | MBCT Group for depression patient, MBCT Group for stress patient |
| psycho-physiological stress regulation groupPhysical 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. | Behavioural | SR group for depression patient, SR group for stress patient |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lue Bee-Horng, MD study director
Department of Family Medicine, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based cognitive Group therapy and psycho-physiological stress regulation group in people with Psychophysiologic Disorders and Stress, Psychological, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2013.