An implementation evaluation of the physical activity counseling in in-patients with major depressive disorder (PACINPAT) randomized controlled trial

Abstract

BackgroundThe physical activity counseling for in-patients with major depression (PACINPAT) randomized controlled trial was launched to tackle physical inactivity in in-patients with major depressive disorder. Evidence shows that despite potential treatment effects, physical inactivity is prevalent in this population. To contribute to the assessment of the impact of this in-person and remote, theory-based, individually tailored intervention, the aim of this study is to evaluate its implementation. MethodsThis implementation evaluation was conducted within a multi-center randomized controlled trial according to the Process Evaluation Framework by the Medical Research Council including the analysis of reach, dose, delity and adaptation. Data were collected from the implementers and the participants randomized to the intervention group of the trial. ResultsThe study sample comprised 95 physically inactive in-patients (mean age: 42 years, 53% women) with diagnosed major depressive disorder. The intervention reached the intended population. The intervention dose varied between early dropouts and study completers with both low and high participation rates.Differences in the attendance groups were recognizable in the rst two counseling sessions. Fidelity of the in-person counseling content was partly achieved and adapted, whereas that of the remote counseling content was well achieved. Participants reported satisfaction with the intervention and the implementers. Adaptations were made to content, delivery mode and dose. ConclusionThe PACINPAT trial was implemented in the intended population, in varying doses and with adaptations made to in-person counseling content and remote counseling dose. These ndings are key to understanding outcome analyses, further developing interventions and contributing to implementation research.