NCT06600126: SERENE

Supporting Evidence-based Responses to Emotional Needs in Emphysema

Recruiting now NA Last updated 30 January 2026

What this trial tests

NA trial testing Coping Skills Training in COPD in 750 participants. Currently enrolling.

Timeline

30 September 2024

Primary endpoint
1 June 2027

5 March 2028

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	750
Start date	30 September 2024
Primary completion	1 June 2027
Estimated completion	5 March 2028
Sites	2 locations across United States

Drugs / interventions tested

• Coping Skills Training
• COPD Education

Conditions studied

• COPD — all drugs for COPD →

Sponsor

University of Pennsylvania

Who can join

18 and older, any sex, with COPD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Hart JL, Carter D, Hinton C, Grilli J, et al · · 2026 · PMID 41742282 · DOI 10.1186/s13063-025-09210-0