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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Coping Skills Training for COPD?

Research suggests that coping skills training, including stress management and psychological support, may improve quality of life for COPD patients. A study found that a telephone-based coping skills intervention improved psychological and physical quality of life and reduced hospitalizations in COPD patients. ^{1 2 3 4 5}

Is coping skills training safe for people with COPD?

The research does not provide specific safety data for coping skills training in COPD patients, but these programs generally focus on education and psychological support, which are typically safe for humans. ^{3 4 5 6 7}

How is the Coping Skills Training treatment different from other treatments for COPD?

Coping Skills Training for COPD is unique because it focuses on improving patients' psychological coping mechanisms, helping them accept their condition, manage stress, and improve their quality of life, rather than directly targeting physical symptoms like other treatments. ^{3 4 6 8 9}

Research Team

Joanna Hart, MD MS

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Coping styles in patients with COPD before and after pulmonary rehabilitation. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled evaluation of a psychosocial intervention in adults with chronic lung disease. [2015]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The role of coping resources and coping style in quality of life of patients with asthma or COPD. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Can a pulmonary health teaching program alter patients' ability to cope with COPD? [2019]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Coping and psychological distress in hospitalized patients with chronic obstructive pulmonary disease. [2006]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of a minimal home-based psychoeducative intervention in patients with advanced COPD: A randomised controlled trial. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

The poorly coping COPD patient: a psychotherapeutic perspective. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The relationship between coping styles and clinical outcomes in patients with COPD entering pulmonary rehabilitation. [2015]