Lessons to learn from pilot studies in clinical trials: The example of a trauma-focused treatment for female survivors of intimate partner violence

Abstract

Background

Research on pilot studies is scarce, despite their importance for the development of effective clinical trials. There is a lack of work addressing the process, limitations and strategies derived from these studies. This gap is even more evident in research studying targeted populations, such as victims of intimate partner violence (IPV), who present specific difficulties, such as high dropout rates, or require the application of challenging treatments, such as trauma-focussed exposure therapy.

Aim

This paper describes a pilot study (PS) implemented as a preliminary step in the development of a clinical trial (CT), in which a trauma-focussed treatment for survivors of IPV with post-traumatic symptomatology was applied. The problems identified in the PS and the solutions that were implemented in the CT are described. Additionally, comparisons between the PS and CT with respect to participant adherence to treatment and satisfaction, as perceived by the participants and the therapist, are analysed.

Results

Results indicate that satisfaction with the treatment was high in both studies; dropouts showed a significant decrease in the CT (25% in CT vs. 75% in the PS; p = .028), while group cohesion increased.

Conclusions

It is concluded that conducting pilot studies allows adapting treatments to the study population, which seems to increase the quality of clinical trials, subsequently improving the evidence of psychological interventions.