Coping Skills Training for COPD

(SERENE Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Joanna Hart, MD MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Pennsylvania

Disqualifiers: Dementia, Cognitive impairment, others

No Placebo Group

Approved in 2 Jurisdictions

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.

Trial 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 (Behavioural Intervention)
• Coping Skills Training (Behavioural Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Henry Ford Health System Detroit, MI

University of Pennsylvania Philadelphia, PA

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2118

Patients Recruited

45,270,000+

Thomas Jefferson University

Collaborator

Trials

475

Patients Recruited

189,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Patients Recruited

10,400,000+

Henry Ford Health System

Collaborator

Trials

334

Patients Recruited

2,197,000+

References

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

Coping styles in patients with COPD before and after pulmonary rehabilitation. [2013] Pulmonary rehabilitation (PR) improves physical and psychological symptoms in COPD patients. Patients' coping with daily symptoms and limitations may have more influence on important patient-centred outcomes than the impaired lung function. To date, it remains unknown whether and to what extent coping styles change following PR, and whether coping styles are associated with the outcomes of a comprehensive PR.

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

A randomized controlled evaluation of a psychosocial intervention in adults with chronic lung disease. [2015] The effect of a stress management program on morbidity and psychosocial and physical function in patients with chronic lung disease was assessed. Adults attending either a VA pulmonary clinic or university hospital pulmonary rehabilitation clinic who met criteria for obstructive or restrictive pulmonary disease were randomly assigned to receive the intervention or to a control group. The intervention was provided by a nurse and included one to three teaching sessions, reading material, audiotapes, and telephone follow-up. The program focused on stress management techniques such as cognitive restructuring, progressive relaxation, breathing exercises, and visual imagery. The 45 experimental subjects were similar to the 49 controls with respect to baseline characteristics. Experimental and control subjects had similar rates of mortality, hospital days, bed-disability days, restricted-activity days, and physician visits during the 12-month follow-up. There were no differences between the two groups in physical or psychosocial function at six months or in levels of stressful life changes, social supports, and self-esteem at six and 12 months. Intervention recipients had better function at 12 months, suggesting a possible benefit of the intervention.

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] Sufficient psychosocial coping resources and an adequate coping style may have a beneficial influence on quality of life in patients with a chronic disease. Until now little research has been directed at these associations and particularly not among patients with asthma or chronic obstructive pulmonary disease (COPD). The objective of this study is to examine the association between psychosocial coping resources and coping style with HRQoL, for asthma and COPD separately.

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

Can a pulmonary health teaching program alter patients' ability to cope with COPD? [2019] Many clinical nurse specialists (CNSs) are involved in providing group teaching programs for individuals with chronic obstructive pulmonary disease (COPD). Although knowledge levels often are enhanced by these programs, what is less well known is whether such programs also can affect the coping methods used by those with this disease. The exploratory study described here was part of a larger research project aimed at determining patients' knowledge, specific psychological parameters (anxiety, hostility, depression), and coping strategies. Thirty people agreed to participate in the study. The Jalowiec Coping Scale (JCS) (Jalowiec & Powers, 1981) was used so that participants could rate each coping method according to the degree of use and to determine whether the methods employed were affective or problem-solving approaches. There was very little change in the pre- and posttest scores on the JCS, indicating that there was little change in coping strategies used. There also were no significant correlations between the JCS scores and the demographic characteristics of age, educational level, and the length of time since diagnosis of COPD. The results of this study seem to indicate that pulmonary rehabilitation programs should place more emphasis on appropriate coping strategies that the COPD patient can incorporate into his or her lifestyle.

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] Chronic obstructive pulmonary disease (COPD) is associated with increased morbidity and mortality and reduced quality of life (QoL). Novel interventions are needed to improve outcomes in COPD patients. The present study assessed the effects of a telephone-based coping skills intervention on psychological and somatic QoL and on the combined medical end point of COPD-related hospitalizations and all-cause mortality.

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

Coping and psychological distress in hospitalized patients with chronic obstructive pulmonary disease. [2006] Previous studies have emphasized the importance of coping in patients with chronic obstructive pulmonary disease (COPD). In other medical conditions, inadequate coping is associated with higher levels of psychological distress. Therefore, the types of coping strategies that patients use may also influence the distress that accompanies an acute exacerbation of COPD.

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] Anxiety is a common comorbidity in patients with advanced Chronic Obstructive Pulmonary Disease (COPD) with major impact on quality of life and associated with increased risk of death. The objective of this randomised controlled trial was to test the efficacy of a minimal home-based psychoeducative intervention versus usual care for reducing symptoms of anxiety in patients with advanced COPD.

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

The poorly coping COPD patient: a psychotherapeutic perspective. [2019] An etiology of maladaptive coping in Chronic Obstructive Pulmonary Disease is proposed and a model for psychotherapeutic intervention with poorly coping COPD patients is presented. Failure in mourning, manifested by a lack of shift in patient's expectations and goals leads to: 1) difficulty in accepting illness related feelings of loss; 2) chronic anxiety; 3) attribution of responsibility for feelings and behavior to external factors; and 4) poor compliance with medical regime. Recommendations for establishing a therapeutic alliance with the poorly coping patient are discussed. Psychotherapeutic intervention aims at: 1) facilitating acceptance of losses and restructuring of life goals; 2) interrupting the cycle of alienation and social withdrawal; and 3) increasing patient's control over affective arousal and respiratory functioning. Utilization of supportive individual psychotherapy, family or marital therapy, and specific behavioral techniques is discussed. Family or marital therapy is seen as the treatment of choice. The psychotherapeutic model proposed is useful in promoting more adaptive coping in the COPD patient.

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

The relationship between coping styles and clinical outcomes in patients with COPD entering pulmonary rehabilitation. [2015] Symptoms of anxiety, depression and exercise intolerance contribute to an impaired health status in patients with Chronic Obstructive Pulmonary Disease (COPD). Coping styles may also be related to symptoms and health status. Objectives of this study were to assess the distribution of coping styles in patients entering pulmonary rehabilitation (PR) with and without anxiety and/or depression; and to assess whether coping styles contribute to exercise intolerance and reduced health status.