Coping Skills Training for COPD

(SERENE Trial)

Recruiting at 1 trial location

Overseen By Joanna Hart, MD, MSHP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Dementia, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

750 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a Coping Skills Training program can reduce depression and anxiety in people with chronic obstructive pulmonary disease (COPD). It compares this program to a regular COPD education program to determine which better improves mental health and overall well-being. The trial focuses on assisting individuals who may face additional challenges, such as those with low income or living in rural areas. Individuals diagnosed with COPD who can attend weekly online sessions for 12 weeks may be suitable candidates. Participants will also complete surveys and may share their experiences in interviews. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance mental health support for COPD patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on coping skills training rather than medication changes.

What prior data suggests that the Coping Skills Training program is safe for people with COPD?

Research has shown that Coping Skills Training can be safe and beneficial for people with COPD. Studies have found that this training improves quality of life by helping individuals manage stress and anxiety. No reports of harm or side effects have emerged from the training itself, likely because it focuses on teaching stress management rather than using medication or medical procedures.

Programs like this are generally well-tolerated, meaning participants typically do not experience negative effects. Therefore, joining a trial that uses Coping Skills Training should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Coping Skills Training for COPD because it offers a fresh, non-pharmacological approach to managing the condition. Unlike typical treatments like bronchodilators and steroids that focus on opening airways and reducing inflammation, this training aims to equip patients with techniques to handle stress and anxiety, which often exacerbate COPD symptoms. By empowering patients with these skills, the hope is to improve their overall quality of life and potentially reduce the frequency of hospital visits. This approach focuses on the mental and emotional aspects of living with COPD, which are often overlooked in traditional treatments.

What evidence suggests that the Coping Skills Training program is effective for reducing depression and anxiety in COPD patients?

Research has shown that Coping Skills Training (CST), a treatment under study in this trial, can improve the quality of life for people with chronic obstructive pulmonary disease (COPD). One study found that patients who received CST managed stress and anxiety more effectively. Another study demonstrated that CST, which includes stress management and emotional support, enhanced the mental health of COPD patients. These findings suggest that CST may reduce depression and anxiety in people with COPD, potentially leading to better overall health. Meanwhile, another arm of this trial will evaluate COPD Education, which focuses on disease management and pulmonary rehabilitation. ^{2 6 7 8 9}

Who Is on the Research Team?

Joanna Hart, MD MS

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for people with COPD, especially emphysema, who may be dealing with depression and anxiety. It's focused on helping those facing health disparities such as low income, different racial backgrounds, or living in rural areas.

Inclusion Criteria

I can make weekly phone or video calls for 3 months.

Patients must score greater than or equal to 8 during baseline screening using the PHQ-8

I have an adult who will support me during my treatment.

Exclusion Criteria

Patients with documentation in the EHR that the COPD diagnosis has not yet been disclosed to the patient

Patients under the ongoing care of a licensed behavioral health clinician

I need to be referred to a specialist for my mental health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 12-week Coping Skills Training program or a COPD Education program

12 weeks

12 weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• COPD Education
• Coping Skills Training

Trial Overview The study compares a Coping Skills Training program (12 weekly sessions of 30 minutes) against a COPD Education program (12 weekly sessions of 10 minutes) to see which better improves mental health outcomes in participants.

How Is the Trial Designed?

Group I: Coping Skills Training Experimental Treatment 1 Intervention

Group II: COPD Education Experimental Treatment 1 Intervention

Coping Skills Training is already approved in United States, European Union for the following indications:

Approved in United States as Coping Skills Training for:

• Chronic Obstructive Pulmonary Disease (COPD) related anxiety and depression

Approved in European Union as Coping Skills Training for:

• COPD-related psychological distress

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

A study of 303 COPD patients showed that after participating in a pulmonary rehabilitation program, patients significantly increased their active coping styles while decreasing avoidance and passive coping strategies, indicating a positive shift in how they manage their condition.

Improvements in coping styles were associated with better exercise tolerance and reductions in anxiety and depression, although these changes did not correlate with overall health status improvements as measured by the St. George's Respiratory Questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping styles in patients with COPD before and after pulmonary rehabilitation. Stoilkova, A., Janssen, DJ., Franssen, FM., et al.[2013]

In a study of 92 patients hospitalized for acute exacerbations of COPD, 64% experienced psychological distress, with most identifying their breathing issues as the main stressor.

The use of problem-solving coping strategies was found to be inversely related to psychological distress, suggesting that encouraging these strategies could help reduce distress during hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping and psychological distress in hospitalized patients with chronic obstructive pulmonary disease. Andenaes, R., Kalfoss, MH., Wahl, AK.[2006]

The proposed model for psychotherapeutic intervention in Chronic Obstructive Pulmonary Disease (COPD) patients focuses on helping them accept their illness and restructure their life goals, which can improve their coping mechanisms.

Family or marital therapy is highlighted as the most effective treatment option, aiming to reduce anxiety, improve compliance with medical regimens, and enhance the patient's control over their emotional and respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The poorly coping COPD patient: a psychotherapeutic perspective. Post, L., Collins, C.[2019]

In a study of 698 COPD patients entering pulmonary rehabilitation, coping styles were linked to symptoms of anxiety and depression, with active coping associated with better exercise tolerance (measured by 6-minute walking distance) and avoidance coping linked to poorer exercise tolerance.

While coping styles influenced exercise capacity, they did not show a significant relationship with overall health status as measured by the St. George's Respiratory Questionnaire, suggesting that improving coping strategies may enhance exercise outcomes but not necessarily health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between coping styles and clinical outcomes in patients with COPD entering pulmonary rehabilitation. Stoilkova, A., Wouters, EF., Spruit, MA., et al.[2015]

A telephone-based coping skills intervention (CST) significantly improved psychological quality of life in COPD patients, reducing depression and anxiety, and enhancing overall mental health and social functioning, compared to standard COPD education.

While CST led to meaningful improvements in quality of life and functional capacity, it did not significantly reduce the risk of COPD-related hospitalizations or all-cause mortality over the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of a telehealth coping skills intervention on outcomes in chronic obstructive pulmonary disease: primary results from the INSPIRE-II study. Blumenthal, JA., Emery, CF., Smith, PJ., et al.[2022]

A minimal home-based psychoeducative intervention significantly reduced anxiety symptoms in patients with advanced COPD, as evidenced by a lower average score on the Hospital Anxiety and Depression scale (HADS-A) compared to usual care, with results maintained at one and three months post-intervention.

The intervention also improved patients' self-management abilities, reflected in higher scores on the Chronic Respiratory Questionnaire (CRQ) domain of mastery, indicating that the intervention not only alleviated anxiety but also enhanced overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a minimal home-based psychoeducative intervention in patients with advanced COPD: A randomised controlled trial. Bove, DG., Lomborg, K., Jensen, AK., et al.[2018]

In a study of 273 patients with asthma and COPD, an emotional coping style was linked to poorer health-related quality of life (HRQoL) for both groups, highlighting the importance of coping strategies in managing chronic diseases.

For asthma patients specifically, lower self-efficacy and mastery, along with an avoidant coping style, were associated with worse HRQoL, while COPD patients showed that a rational coping style was also linked to poorer HRQoL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of coping resources and coping style in quality of life of patients with asthma or COPD. Hesselink, AE., Penninx, BW., Schlösser, MA., et al.[2018]

A study involving 30 participants with chronic obstructive pulmonary disease (COPD) found that group teaching programs improved knowledge but did not significantly change the coping strategies used by patients, as measured by the Jalowiec Coping Scale.

The lack of change in coping methods suggests that pulmonary rehabilitation programs should focus more on teaching effective coping strategies to help patients manage their condition better.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a pulmonary health teaching program alter patients' ability to cope with COPD? Janelli, LM., Scherer, YK., Schmieder, LE.[2019]

A stress management program for patients with chronic lung disease, involving techniques like cognitive restructuring and relaxation exercises, showed no significant differences in morbidity or psychosocial and physical function compared to a control group over 12 months.

However, participants in the intervention group reported better functional outcomes at the 12-month mark, indicating a potential benefit from the stress management techniques used in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled evaluation of a psychosocial intervention in adults with chronic lung disease. Blake, RL., Vandiver, TA., Braun, S., et al.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4197099/

The Effects of a Telehealth Coping Skills Intervention on ... The goal of the present study was to evaluate the efficacy of a telehealth coping skills training (CST) intervention for improving QoL and medical outcomes in ...

2. withpower.com withpower.com/trial/coping-skills-training-for-copd-52bd6

Coping Skills Training for COPD (SERENE Trial) Research suggests that coping skills training, including stress management and psychological support, may improve quality of life for COPD patients. A study ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0954611105004099

Psychological outcomes of an outpatient pulmonary ... The 26 rehabilitation patients with COPD were compared with 19 control patients with COPD similar in age, gender, COPD severity and other variables.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12545121/

The impact of social and psychological support on patients ... Abstract. Objective. To investigate the effects of social support and psychological interventions on COPD patients across varying severity levels.

5. publications.ersnet.org publications.ersnet.org/content/erj/44/6/1538

A self-management programme for COPD: a randomised ... The Self-Management Programme of Activity, Coping and Education (SPACE) FOR COPD is a 6-week self-management intervention for COPD, and this study aimed to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2690229/

Caregiver-assisted coping skills training for patients with ... Measures will include assessments of somatic symptoms (fatigue, cough, and dyspnea), depression, anxiety, QoL, coping, communication, self-efficacy for symptom ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714413000955

A self-management approach using self-initiated action ... A self-management approach using self-initiated action plans for symptoms with ongoing nurse support in patients with Chronic Obstructive Pulmonary Disease ( ...

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1659691/full

The impact of social and psychological support on patients ... Objective: To investigate the effects of social support and psychological interventions on COPD patients across varying severity levels.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03461887

Home-based Exercise Training for COPD Patients The aim of this study is to assess the effectiveness of a home-based exercise training program in COPD patients who have completed a pulmonary rehabilitation.