COPDSERENENCT06600126
Supporting Evidence-based Responses to Emotional Needs in Emphysema
A study testing Coping Skills Training and COPD Education in people with COPD, run by University of Pennsylvania at 2 sites in United States.
Trial summary
The goal of this clinical trial is to understand how a Coping Skills Training program can reduce depression and anxiety in people with chronic obstructive pulmonary disease (COPD), particularly those who face health disparities, including those with low income, different racial backgrounds, or those living in rural… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Coping Skills Training and COPD Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2024to 5 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients
- Be at least 18 years of age
- Have a documented diagnosis of COPD and confirmation of obstructive lung disease by spirometry (American Thoracic Society/European Respiratory Society guidelines) or radiology (imaging report indicating emphysematous changes)
- Score greater than or equal to 8 during baseline screening using the PHQ-8
- Identify an adult caregiver to participate with them
- Have the ability to access a telephone or videoconferencing call up to once weekly (for approximately 30 minutes) for 12 sessions of the study intervention
Show all 10Show fewer
- Spoken proficiency in Spanish and/or English
- Caregivers
- Be at least 18 years of age
- Have the ability to access a telephone or videoconferencing call up to once weekly (for approximately 30 minutes) for 12 weeks
Who cannot join
- Patients
- Has significant dementia or cognitive impairment
- Documentation in the EHR that the COPD diagnosis has not yet been disclosed to the patient
- Is under the ongoing care of a licensed behavioral health clinician
- Requires immediate referral to specialized behavioral health management
- Caregivers
- Has significant dementia or cognitive impairment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Lisa Matero, PhD, 313-874-6677, lmatero1@hfhs.org
Lisa Matero, PhD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Joanna Hart, MD, MSHP, 267-271-0665, Joanna.Hart@pennmedicine.upenn.edu
Daniel Carter, 215-573-7082, Daniel.Carter@pennmedicine.upenn.edu
About this study
The goal of this clinical trial is to understand how a Coping Skills Training program can reduce depression and anxiety in people with chronic obstructive pulmonary disease (COPD), particularly those who face health disparities, including those with low income, different racial backgrounds, or those living in rural areas. The main questions it aims to answer are:
- How does the Coping Skills Training program help reduce stress and anxiety in patients?
- What causes variations in the effectiveness of the Coping Skills Training program?
- What are the barriers and facilitators to the uptake of the Coping Skills Training program?
Read more
Researchers will compare a 12-week Coping Skills Training program with a COPD Education program to see if the training leads to better health outcomes for participants.
Participants will:
- Take part in weekly 30-minute sessions for 12 weeks if assigned to the Coping Skills Training group.
- Take part in weekly 10-minute sessions for 12 weeks if assigned to the COPD Education group.
- Complete surveys before, during, and after the intervention.
- Patients and caregivers, including those who chose not to enroll, as well as clinicians, will be invited to participate in interviews to share their perspectives.
Read the detailed description
Social environments, including family structure and function, shape patients' care and outcomes. Yet the role of family caregivers in chronic illness care is often unrecognized or undervalued even when critically relevant. For example, psychological distress is highly prevalent among patients with chronic obstructive pulmonary disease (COPD). COPD affects more than 212 million people worldwide, annual US medical costs are over $49 billion, and groups experiencing health disparities are most affected. Family caregivers, patients, and clinicians identify emotional symptoms and coping as critical priorities in COPD care. Psychological distress is strongly associated with poor quality of life and clinical outcomes for patients with COPD, such as more frequent exacerbations and higher post-discharge mortality. Yet affected patients rarely receive psychological care, particularly patients who face barriers to behavioral health care access. Integrating families into approaches to reduce patients' psychological distress is likely to improve outcomes and equity.
The investigators' overarching objective is to reduce the burden of chronic illness on patients and families. The central hypothesis is that improving patients' coping skills and caregivers' ability to coach patients in use of these skills will improve patients' outcomes. The existing evidence amongst patients with COPD is strongest for non- pharmacological interventions for psychological distress, but fails to represent diverse study populations. High-quality family relationships (i.e., cohesion, problem solving, and communication) are associated with better clinical outcomes. Among patients with COPD, better family relationship quality is associated with reduced psychological distress and improved self-management and dyspnea. Coping Skills Training is a scalable intervention that uses cognitive-behavioral skills to teach patient-caregiver dyads how to respond to the many emotional, physical, functional, and psychosocial consequences of COPD. In an NIH-funded trial of 326 dyads, Coping Skills Training improved patients' psychological and health-related quality of life more than an educational control. Yet, the mechanisms of the intervention's success remain unknown and the prior work underrepresented groups experiencing health disparities. Filling these critical knowledge gaps is an urgent need that will allow the investigators to refine and scale effective and efficient interventions addressing this critical need.
The investigators propose a randomized clinical trial to test putative treatment mechanisms through which the Coping Skills Training program administered to patients with COPD and their family caregivers improves outcomes. Outpatients with COPD who screen positive for psychological distress will be randomized in a 2:1 ratio to participate in a 12-week program with a caregiver, either a Coping Skills Training program (i.e., weekly 30-minute protocolized sessions delivered by a behavioral health specialist) or COPD Education program (i.e., weekly 10-minute sessions without coping skills).
- Conditions
- COPD
- Being tested
- Coping Skills Training, COPD Education
- Keywords
- Pulmonary Disease, Coping Skills, Psychological Distress, Mixed Methods
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping Skills TrainingBehavioural
The Coping Skills Training arm will consist of 12 weekly 30-minute sessions via videoconferencing or phone. A trained research staff member will deliver sessions that focus on building coping skills for patients with COPD, such as progressive relaxation training, pleasant activity scheduling, and building communication skills. Caregivers will also participate, learning how to support the patient in using these skills. Participants will complete assignments between sessions to reinforce their learning. Additionally, participants will receive a Coping Skills Training workbook.
COPD EducationBehavioural
The COPD Education arm will consist of 12 weekly 10-minute sessions via videoconferencing or phone. A trained research staff member will provide scripted general support and encouragement without using specific psychoeducational techniques. Caregivers will also participate. Additionally, participants will receive a COPD Education workbook with material from The COPD Foundation, which is also available on the Foundation's website. This program augments usual care, providing an attention control for comparison.
| Study group | Role | What they receive |
|---|---|---|
| Coping Skills Training | Experimental | Not described Receives: Behavioral: Coping Skills Training |
| COPD Education | Experimental | Not described Receives: Behavioral: COPD Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Psychological Distress
Patient psychological distress will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, with total scores ranging from 0 to 27. Higher scores indicate greater distress.
Measured: Baseline, 14 weeks
Secondary outcomes (13)
Patient Psychological Distress (Secondary Outcome)
Patient psychological distress will be measured as a secondary outcome using the Patient Health Questionnaire-9 (PHQ-9) after 7 weeks and 14 weeks. As described above, the PHQ-9 consists of 9 items, with total scores ranging from 0 to 27. Higher scores indicate greater distress.
Measured: Baseline, 7 weeks, 26 weeks
Patient Anxiety
Patient anxiety will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 consists of 7 items, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety.
Measured: Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (St. George's Respiratory Questionnaire for COPD patients)
Health-related quality of life will be measured using the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C). The SGRQ-C consists of 40 items, with total scores ranging from 0 to 100. Higher scores indicate greater limitations and poorer health-related quality of life.
Measured: Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (mMRC Dyspnoea Scale)
Health-related quality of life will also be measured using the Modified Medical Research Council (mMRC) Dyspnoea Scale. The mMRC consists of 1 item, with a 5-point scale from 0 to 4. Higher scores indicate poorer health-related quality of life.
Measured: Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (COPD Assessment Test™)
Health-related quality of life will also be measured using the COPD Assessment Test™ (CAT™). The CAT consists of 8 items, with total scores ranging from 0 to 40. Higher scores indicate poorer health-related quality of life.
Measured: Baseline, 7 weeks, 14 weeks, 26 weeks
Time to COPD-Related Hospitalization
Time to COPD-related hospitalization will be assessed by reviewing electronic health records for hospitalizations occurring within the 12-month period following enrollment. Hospitalizations will be identified as COPD-related if the condition is listed as a primary or secondary diagnosis, or if the records indicate that COPD was an active or contributory condition. Time to COPD hospitalization will be measured in days from the trial enrollment date.
Measured: 12 months following enrollment
All-Cause Mortality
All-cause mortality will be tracked through electronic health record reviews. Additional data will be gathered from caregivers and confirmed through Internet obituary searches, if necessary, to ensure accurate capture of deaths not recorded in medical records.
Measured: 12 months following enrollment
Caregiver Burden
Caregiver burden will be measured using the Zarit Caregiver Burden Inventory (ZBI). The ZBI consists of 22 items, with total scores ranging from 0 to 88. Higher scores indicate greater burden.
Measured: Baseline, 7 weeks, 14 weeks, 26 weeks
Family Relationship Quality
Family relationship quality will be measured using the Family Emotional Involvement and Criticism Scale (FEICS). The FEICS consists of 14 items with 2 subscales (perceived criticism and emotional involvement), each with total scores ranging from 0 to 28. Higher scores indicate more expressed emotion in family relationships.
Measured: Baseline, 5 weeks, 12 weeks, 24 weeks
Self-Efficacy
Self-efficacy will be measured among patients and caregivers using the General Self-Efficacy Scale (GSE). The GSE consists of 10 items, with total scores ranging from 10 to 40. Higher scores indicate greater self-efficacy.
Measured: Baseline, 5 weeks, 12 weeks, 24 weeks
Patient Loneliness
Patient-reported loneliness will be measured using the UCLA Loneliness Scale. The UCLA Loneliness Scale consists of 20 items, with total scores ranging from 20 to 80. Lower scores indicate greater feelings of loneliness.
Measured: Baseline, 5 weeks, 12 weeks, and 24 weeks following enrollment
Caregivers' Psychological Distress
Caregivers' psychological distress will be measured using the PHQ-9. As described above, the PHQ-9 consists of 9 items, with total scores ranging from 0 to 27. Higher scores indicate greater distress.
Measured: Baseline, 5 weeks, 12 weeks, 24 weeks
Caregiver Anxiety
Caregivers' anxiety will be measured using the Generalized Anxiety Disorder-7 (GAD-7). As described above, the GAD-7 consists of 7 items, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety.
Measured: Baseline, 5 weeks, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start30 Sep 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion5 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Henry Ford Health System, Thomas Jefferson University
- Responsible party
- Sponsor
- Investigators
- Joanna Hart, MD, MSHP, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600126
- Sponsor's protocol ID
- 852619
- Other IDs
- R01NR020819
- Acronym
- SERENE
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Three datasets will be generated: (1) survey data from participants (patients and caregivers), (2) electronic health record data from patient participants, and (3) interview data from patients, caregivers, and clinicians. These datasets will be shared through the Inter-university Consortium for Political and Social Research (ICPSR) data repository. The shared data will be de-identified according to ICPSR's de-identification standards.
Publications
Hart JL, Carter D, Hinton C, Grilli J, Brown LA, Brier N, Lu Y, Whitman C, Harhay MO, Sims M, Alvarez C, Miller-Matero LR, O'Hayer CV. Supporting Evidence-based Responses to Emotional Needs in Emphysema (SERENE): protocol for a randomized, open-label mechanistic trial comparing Coping Skills Training and disease-specific education for depressive symptoms conducted in United States health systems. Trials. 2026 Feb 25;27(1):262. doi: 10.1186/s13063-025-09210-0.
PubMed 41742282
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Evidence-based Responses to Emotional Needs in Emphysema
- ClinicalTrials.gov ID
- NCT06600126
- Acronym / sponsor ID
- SERENE / 852619
- Conditions
- COPD
- Keywords
- Pulmonary Disease, Coping Skills, Psychological Distress, Mixed Methods
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), Henry Ford Health System, Thomas Jefferson University
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 5 Mar 2028 (estimated)
- First posted
- 19 Sep 2024 (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.
The goal of this clinical trial is to understand how a Coping Skills Training program can reduce depression and anxiety in people with chronic obstructive pulmonary disease (COPD), particularly those who face health disparities, including those with low income, different racial backgrounds, or those living in rural areas. The main questions it aims to answer are:
- How does the Coping Skills Training program help reduce stress and anxiety in patients?
- What causes variations in the effectiveness of the Coping Skills Training program?
- What are the barriers and facilitators to the uptake of the Coping Skills Training program?
Researchers will compare a 12-week Coping Skills Training program with a COPD Education program to see if the training leads to better health outcomes for participants.
Participants will:
- Take part in weekly 30-minute sessions for 12 weeks if assigned to the Coping Skills Training group.
- Take part in weekly 10-minute sessions for 12 weeks if assigned to the COPD Education group.
- Complete surveys before, during, and after the intervention.
- Patients and caregivers, including those who chose not to enroll, as well as clinicians, will be invited to participate in interviews to share their perspectives.
Detailed description
Social environments, including family structure and function, shape patients' care and outcomes. Yet the role of family caregivers in chronic illness care is often unrecognized or undervalued even when critically relevant. For example, psychological distress is highly prevalent among patients with chronic obstructive pulmonary disease (COPD). COPD affects more than 212 million people worldwide, annual US medical costs are over $49 billion, and groups experiencing health disparities are most affected. Family caregivers, patients, and clinicians identify emotional symptoms and coping as critical priorities in COPD care. Psychological distress is strongly associated with poor quality of life and clinical outcomes for patients with COPD, such as more frequent exacerbations and higher post-discharge mortality. Yet affected patients rarely receive psychological care, particularly patients who face barriers to behavioral health care access. Integrating families into approaches to reduce patients' psychological distress is likely to improve outcomes and equity.
The investigators' overarching objective is to reduce the burden of chronic illness on patients and families. The central hypothesis is that improving patients' coping skills and caregivers' ability to coach patients in use of these skills will improve patients' outcomes. The existing evidence amongst patients with COPD is strongest for non- pharmacological interventions for psychological distress, but fails to represent diverse study populations. High-quality family relationships (i.e., cohesion, problem solving, and communication) are associated with better clinical outcomes. Among patients with COPD, better family relationship quality is associated with reduced psychological distress and improved self-management and dyspnea. Coping Skills Training is a scalable intervention that uses cognitive-behavioral skills to teach patient-caregiver dyads how to respond to the many emotional, physical, functional, and psychosocial consequences of COPD. In an NIH-funded trial of 326 dyads, Coping Skills Training improved patients' psychological and health-related quality of life more than an educational control. Yet, the mechanisms of the intervention's success remain unknown and the prior work underrepresented groups experiencing health disparities. Filling these critical knowledge gaps is an urgent need that will allow the investigators to refine and scale effective and efficient interventions addressing this critical need.
The investigators propose a randomized clinical trial to test putative treatment mechanisms through which the Coping Skills Training program administered to patients with COPD and their family caregivers improves outcomes. Outpatients with COPD who screen positive for psychological distress will be randomized in a 2:1 ratio to participate in a 12-week program with a caregiver, either a Coping Skills Training program (i.e., weekly 30-minute protocolized sessions delivered by a behavioral health specialist) or COPD Education program (i.e., weekly 10-minute sessions without coping skills).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coping Skills Training | Experimental | Behavioral: Coping Skills Training |
| COPD Education | Experimental | Behavioral: COPD Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients
- Be at least 18 years of age
- Have a documented diagnosis of COPD and confirmation of obstructive lung disease by spirometry (American Thoracic Society/European Respiratory Society guidelines) or radiology (imaging report indicating emphysematous changes)
- Score greater than or equal to 8 during baseline screening using the PHQ-8
- Identify an adult caregiver to participate with them
Key exclusion criteria (7 listed)
- Patients
- Has significant dementia or cognitive impairment
- Documentation in the EHR that the COPD diagnosis has not yet been disclosed to the patient
- Is under the ongoing care of a licensed behavioral health clinician
- Requires immediate referral to specialized behavioral health management
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 |
|---|---|---|
| Coping Skills TrainingThe Coping Skills Training arm will consist of 12 weekly 30-minute sessions via videoconferencing or phone. A trained research staff member will deliver sessions that focus on building coping skills for patients with COPD, such as progressive relaxation training, pleasant activity scheduling, and building communication skills. Caregivers will also participate, learning how to support the patient in using these skills. Participants will complete assignments between sessions to reinforce their learning. Additionally, participants will receive a Coping Skills Training workbook. | Behavioural | Coping Skills Training |
| COPD EducationThe COPD Education arm will consist of 12 weekly 10-minute sessions via videoconferencing or phone. A trained research staff member will provide scripted general support and encouragement without using specific psychoeducational techniques. Caregivers will also participate. Additionally, participants will receive a COPD Education workbook with material from The COPD Foundation, which is also available on the Foundation's website. This program augments usual care, providing an attention control for comparison. | Behavioural | COPD Education |
Primary outcome
Patient Psychological Distress
Time frame: Baseline, 14 weeks
Patient psychological distress will be measured using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 consists of 9 items, with total scores ranging from 0 to 27. Higher scores indicate greater distress.
13 secondary outcomes
Patient Psychological Distress (Secondary Outcome)
Time frame: Baseline, 7 weeks, 26 weeks
Patient Anxiety
Time frame: Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (St. George's Respiratory Questionnaire for COPD patients)
Time frame: Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (mMRC Dyspnoea Scale)
Time frame: Baseline, 7 weeks, 14 weeks, 26 weeks
Health-Related Quality of Life (COPD Assessment Test™)
Time frame: Baseline, 7 weeks, 14 weeks, 26 weeks
Time to COPD-Related Hospitalization
Time frame: 12 months following enrollment
All-Cause Mortality
Time frame: 12 months following enrollment
Caregiver Burden
Time frame: Baseline, 7 weeks, 14 weeks, 26 weeks
Family Relationship Quality
Time frame: Baseline, 5 weeks, 12 weeks, 24 weeks
Self-Efficacy
Time frame: Baseline, 5 weeks, 12 weeks, 24 weeks
Patient Loneliness
Time frame: Baseline, 5 weeks, 12 weeks, and 24 weeks following enrollment
Caregivers' Psychological Distress
Time frame: Baseline, 5 weeks, 12 weeks, 24 weeks
Caregiver Anxiety
Time frame: Baseline, 5 weeks, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Derived from this study: PubMed 41742282Hart JL, Carter D, Hinton C, Grilli J, Brown LA, Brier N, Lu Y, Whitman C, Harhay MO, Sims M, Alvarez C, Miller-Matero LR, O'Hayer CV. Supporting Evidence-based Responses to Emotional Needs in Emphysema (SERENE): protocol for a randomized, open-label mechanistic trial comparing Coping Skills Training and disease-specific education for depressive symptoms conducted in United States health systems. Trials. 2026 Feb 25;27(1):262. doi: 10.1186/s13063-025-09210-0.
- Individual participant dataSharing planned: Yes. Three datasets will be generated: (1) survey data from participants (patients and caregivers), (2) electronic health record data from patient participants, and (3) interview data from patients, caregivers, and clinicians. These datasets will be shared through the Inter-university Consortium for Political and Social Research (ICPSR) data repository. The shared data will be de-identified according to ICPSR's de-identification standards.
Related trials for COPD
Active, not recruitingPhase 2
Effect of Ensifentrine (MK-5884/RPL554) on Sputum Markers of Inflammation in Chronic Obstructive Pulmonary Disease (COPD) (MK-5884-023/RPL554-CO-207)
Pulmonary Disease, Chronic Obstructive, COPD
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
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.
Joanna Hart, MD, MSHP principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping Skills Training and COPD Education in people with COPD, run by University of Pennsylvania at 2 sites in United States.
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 10 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna Hart, MD, MSHP (267-271-0665, Joanna.Hart@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Psychological Distress (time frame: Baseline, 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06600126, which also lists 1 linked publication.
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 30 Jan 2026; AzTrials last refreshed its copy on 4 Nov 2026.