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

BACKGROUND: Depressive symptoms and anxiety are highly prevalent among people with chronic obstructive pulmonary disease (COPD), strongly associated with poor outcomes, and rarely recognized or treated. Integrating families into interventions may amplify supportive care treatment effects and overcome common challenges, yet this strategy is understudied. The Supporting Evidence-based Responses to Emotional Needs in Emphysema (SERENE) trial’s main objective is to identify the mechanisms through which a family-partnered Coping Skills Training (CST) reduces depressive symptoms among patients with COPD, testing five putative mechanisms: family relationship quality, patient and caregiver self-efficacy, patient loneliness, and caregiver psychological distress.

METHODS: SERENE will enroll 375 patient-support person (i.e., family caregiver) dyads from two academic health systems. Eligible patients have documented COPD, elevated levels of depressive symptoms (i.e. PHQ-8 scores ≥ 8), and age ≥ 18 years old. Ineligible participants are those with new or changing behavioral health treatments or behavioral health emergencies. After enrollment by research staff, we randomize dyads in a 2:1 ratio to receive either a 12-week CST program or a 12-week COPD education program, respectively. Both are delivered to the dyads via phone or videoconferencing sessions and, therefore, arm assignment is not blinded to staff nor participants. We will test whether randomization to receipt of CST leads to improvements in patients’ depressive symptoms and test mechanisms of efficacy. The primary efficacy outcome is PHQ-9 scores 14 weeks following enrollment. Our five putative mechanisms, corresponding to those previously specified, are measured with the Family Emotional Involvement and Criticism Scale, the General Self-efficacy Scale, the UCLA Loneliness Scale, the PHQ-9, and the Generalized Anxiety Disorder-7. We will measure secondary outcomes through 12 months. Those performing data analyses will remain blinded to group assignments at the individual level until completion of the primary analyses. The study team identifies and reports serious adverse events (i.e., suicidal behaviors or psychiatric hospitalizations).

DISCUSSION: SERENE will determine how scalable supportive care interventions that strengthen existing social networks, including the crucial support of family caregivers, improve outcomes in COPD. The results will lay the foundation for paradigm-shifting approaches to managing COPD and similar illnesses through family-directed supportive care interventions.

National Institute of Nursing Research

Joanna L Hart, Daniel Carter, Chloe Hinton, James Grilli, Lily A Brown, Nora Brier, Yingying Lu, Casey Whitman, Michael O Harhay, Michael Sims, Carmen Alvarez, Lisa R Miller-Matero, C Virginia O’Hayer