COPDNCT03187249
Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression
A study testing Cognitive Behavioral Therapy, Pulmonary Rehabilitation Therapy and Combined Therapy in people with COPD and Anxiety, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary disease (COPD). Intervention strategy including behavioral-cognitive therapy and pulmonary rehabilitation are promising in improving life quality, disease symptom and outcomes. But there's not standard algorithm in China so far. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- COPD, Anxiety, Depression
- What is being tested?
- Cognitive Behavioral Therapy, Pulmonary Rehabilitation Therapy and Combined Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2017to 31 Dec 2020
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable COPD patients with mild or moderate anxiety and depression
Who cannot join
- Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
- Patients with tumor history during past 5 years
- Patients with COPD exacerbations during past 4 weeks
- Participants in clinical trials
- Patients in pregnancy or breastfeeding
- Patients unable to complete questionaire independently
- Patients older than 80 years old
- Patients receiving long-term domiciliary oxygen therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Jiangna Han, MD, 13520053104, 13520053104@139.com
About this study
Anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary disease (COPD). Intervention strategy including behavioral-cognitive therapy and pulmonary rehabilitation are promising in improving life quality, disease symptom and outcomes. But there's not standard algorithm in China so far. The study aims to compare the effectiveness of these interventions and develop an intervention algorithm of anxiety and depression in COPD.
- Conditions
- COPD, Anxiety, Depression
- Being tested
- Cognitive Behavioral Therapy, Pulmonary Rehabilitation Therapy, Combined Therapy
- 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.
Cognitive Behavioral TherapyBehavioural
12 weeks cognitive-behavioral lessons, once a week
Pulmonary Rehabilitation TherapyBehavioural
12 weeks pulmonary rehabilitation exercise
Combined TherapyBehavioural
cognitive-behavioral lessons and pulmonary rehabilitation exercise for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | receive cognitive-behavioral therapy for 12 weeks Receives: Behavioral: Cognitive Behavioral Therapy |
| Pulmonary Rehabilitation Therapy | Experimental | receive pulmonary rehabilitation therapy for 12 weeks Receives: Behavioral: Pulmonary Rehabilitation Therapy |
| Combined Therapy | Experimental | receive both cognitive-behavioral therapy and pulmonary rehabilitation therapy for 12 weeks Receives: Behavioral: Combined Therapy |
| Regular Therapy | No intervention | receive regular therapy for chronic obstructive pulmonary disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
total score
Measured: 12 weeks
Secondary outcomes (3)
moderate and severe COPD exacerbations
total times
Measured: 3 years
modified British medical research council score
total score
Measured: 3 years
COPD assessment test score
total score
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start15 Jun 2017 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (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.
- More trials run by Chinese Academy of Medical Sciences, Fuwai 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187249
- Sponsor's protocol ID
- 2016YFC1304404B
- Status last verified
- Jun 2017
- First submitted
- 13 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Strategy in Chronic Obstructive Pulmonary Disease With Anxiety and Depression
- ClinicalTrials.gov ID
- NCT03187249
- Acronym / sponsor ID
- 2016YFC1304404B
- Conditions
- COPD, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 14 Jun 2017 (actual)
- 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.
Anxiety and depression have negative effect on outcomes of chronic obstructive pulmonary disease (COPD). Intervention strategy including behavioral-cognitive therapy and pulmonary rehabilitation are promising in improving life quality, disease symptom and outcomes. But there's not standard algorithm in China so far. The study aims to compare the effectiveness of these interventions and develop an intervention algorithm of anxiety and depression in COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral Therapyreceive cognitive-behavioral therapy for 12 weeks |
| Pulmonary Rehabilitation Therapy | Experimental | Behavioral: Pulmonary Rehabilitation Therapyreceive pulmonary rehabilitation therapy for 12 weeks |
| Combined Therapy | Experimental | Behavioral: Combined Therapyreceive both cognitive-behavioral therapy and pulmonary rehabilitation therapy for 12 weeks |
| Regular Therapy | No intervention | –receive regular therapy for chronic obstructive pulmonary disease |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Stable COPD patients with mild or moderate anxiety and depression
Key exclusion criteria (8 listed)
- Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
- Patients with tumor history during past 5 years
- Patients with COPD exacerbations during past 4 weeks
- Participants in clinical trials
- Patients in pregnancy or breastfeeding
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 |
|---|---|---|
| Cognitive Behavioral Therapy12 weeks cognitive-behavioral lessons, once a week | Behavioural | Cognitive Behavioral Therapy |
| Pulmonary Rehabilitation Therapy12 weeks pulmonary rehabilitation exercise | Behavioural | Pulmonary Rehabilitation Therapy |
| Combined Therapycognitive-behavioral lessons and pulmonary rehabilitation exercise for 12 weeks | Behavioural | Combined Therapy |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: 12 weeks
total score
3 secondary outcomes
moderate and severe COPD exacerbations
Time frame: 3 years
modified British medical research council score
Time frame: 3 years
COPD assessment test score
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy, Pulmonary Rehabilitation Therapy and Combined Therapy in people with COPD and Anxiety, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 1 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 14 Jun 2017. 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 Jiangna Han, MD (13520053104, 13520053104@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Anxiety and Depression Scale (time frame: 12 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 Jun 2017.