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LiveWell: Pilot Feasibility Trial of an Adapted Dialectical Behavioral Therapy Skills Training Protocol in Patients
Kelly A Hyland1,2,3, Andrada D Neacsiu4, Hannah M Fisher1
1Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina, USA.
Background:
People living longer with metastatic non-small cell lung cancer (mNSCLC) experience heightened psychological distress and decrements in quality of life. Therefore, we developed LiveWell, an 8-session adapted dialectical behavioral therapy skills training (DBT-ST) protocol delivered one-on-one via telehealth to reduce psychological distress.
Aim:
To conduct a single-arm pilot trial examining the feasibility and acceptability of LiveWell and explore change in outcome variables.
Methods:
Patients receiving systemic therapy for mNSCLC with at least mild distress participated. Outcomes were feasibility (accrual N = 30 in 18 months, > 80% sessions attended, < 25% attrition) and acceptability (> 80% participant satisfaction). Distress (depression and anxiety symptoms; primary outcomes), intolerance of uncertainty, emotion regulation, illness acceptance, symptoms (e.g., fatigue, dyspnea, pain), skill use, and quality of life (secondary outcomes) were assessed at baseline, post-intervention (primary endpoint), and 1-month post-intervention and examined with paired sample t-tests.
Results:
Thirty participants (Mage = 63 years, 77% female) consented and completed the baseline assessment. LiveWell met feasibility (accrual N = 30 in 8 months, 93% sessions attended, 87% retention at post-intervention) and acceptability (96% satisfaction) benchmarks. Participants demonstrated reductions in distress (depression d = 0.35, anxiety d = 0.22) from baseline to post-treatment. Intolerance of uncertainty (d = 0.71), emotion regulation (d = 0.49), and illness acceptance (d = 0.45) improved. Fatigue and pain remained stable or improved (d's 0.07-0.38). Skill use increased (d = 0.65) and quality of life improved (d = 0.21). Improvements were maintained or enhanced at 1-month follow-up.
Conclusions:
LiveWell was feasible and acceptable, and participants demonstrated promising improvement in primary and secondary outcomes. Findings support a larger randomized efficacy trial.
Trial Registration:
ClinicalTrials.gov Identifier: NCT04973436.
