COPDNCT02413840
Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable COPD Patients
A study testing Baduanjin qigong in people with COPD and Anxiety, run by Huimin Gong at 1 site in China.
Trial summary
This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COPD, Anxiety, Depression
- What is being tested?
- Baduanjin qigong
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to May 2015
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed of COPD
- In stable phase
- FEV1%predicted <80.
Who cannot join
- Cancer
- Severe cerebrovascular disease
- Severe arrhythmia,cardiac insufficiency
- Alzheimer's disease
- Mental illness
- Severe liver disfunction
- Severe renal disfunction
- Physical activity disable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing institute of respiratory diseases
Beijing
Ting Yang, 8613651380809
About this study
Official title: Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable Chronic Obstructive Pulmonary Disease Patients
This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.
Read the detailed description
Anxiety and depression is one of the most common complications of COPD patients.This research use psychological questionnaires to evaluate the stage of COPD patients with anxiety and/or depression(asymptomatic, subclinical，clinical). The subclinical type will divided into the treatment group of Baduanjin qigong，and the control group. Two groups are all receive the same psychological counseling, the treatment group also receive further treatment of Baduanjin qigong under the guidance of medical staff. The treatment along for 1 year. Two groups were followed up for 2 years, dynamically observe the stage of anxiety and depression,the number of exacerbations,lung function,etc.
- Conditions
- COPD, Anxiety, Depression
- Being tested
- Baduanjin qigong
- Keywords
- COPD, Baduanjin qigong, depression, anxiety
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin qigongBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin qigong group | Experimental | Doing exercise of Baduanjin qigong under the guidance of medical staff;psychological counseling at the same time. Receives: Behavioral: Baduanjin qigong |
| control group | No intervention | Psychological counseling only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stage of anxiety and depression ((Hospital Anxiety and Depression Scale)
use psychological questionnaires(Hospital Anxiety and Depression Scale,etc)to evaluate the stage of anxiety and/or depression
Measured: one year
Secondary outcomes (2)
the number of acute exacerbations
Measured: one year
lung function (pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected)
use pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huimin Gong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huimin Gong, Capital Medical University
- Investigators
- Ting Yang, Study chair, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413840
- Sponsor's protocol ID
- CMU900314
- Status last verified
- Apr 2015
- First submitted
- 4 Feb 2015
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation, Psychological Intervention and Follow-up Study of Anxiety and Depression in Stable Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT02413840
- Acronym / sponsor ID
- CMU900314
- Conditions
- COPD, Anxiety, Depression
- Keywords
- COPD, Baduanjin qigong, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Huimin GongUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 10 Apr 2015 (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.
This study expect to investigate psychological intervention (Baduanjin qigong) in COPD patients combined with anxiety and/or depression.
Detailed description
Anxiety and depression is one of the most common complications of COPD patients.This research use psychological questionnaires to evaluate the stage of COPD patients with anxiety and/or depression(asymptomatic, subclinical，clinical). The subclinical type will divided into the treatment group of Baduanjin qigong，and the control group. Two groups are all receive the same psychological counseling, the treatment group also receive further treatment of Baduanjin qigong under the guidance of medical staff. The treatment along for 1 year. Two groups were followed up for 2 years, dynamically observe the stage of anxiety and depression,the number of exacerbations,lung function,etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin qigong group | Experimental | Behavioral: Baduanjin qigongDoing exercise of Baduanjin qigong under the guidance of medical staff;psychological counseling at the same time. |
| control group | No intervention | –Psychological counseling only. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed of COPD
- In stable phase
- FEV1%predicted <80.
Key exclusion criteria (8 listed)
- Cancer
- Severe cerebrovascular disease
- Severe arrhythmia,cardiac insufficiency
- Alzheimer's disease
- Mental illness
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 |
|---|---|---|
| Baduanjin qigong | Behavioural | Baduanjin qigong group |
Primary outcome
stage of anxiety and depression ((Hospital Anxiety and Depression Scale)
Time frame: one year
use psychological questionnaires(Hospital Anxiety and Depression Scale,etc)to evaluate the stage of anxiety and/or depression
2 secondary outcomes
the number of acute exacerbations
Time frame: one year
lung function (pulmonary function test(20 minutes after inhaled 400ug albuterol),the forced expiratory volume in 1 second(FEV1)will be detected)
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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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.
Ting Yang study chair
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin qigong in people with COPD and Anxiety, run by Huimin Gong at 1 site in China.
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 3 inclusion and 8 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 10 Apr 2015. 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 China. 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?
Contact Huimin Gong (8613436379130, 570866508@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stage of anxiety and depression ((Hospital Anxiety and Depression Scale) (time frame: one year). 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 10 Apr 2015.