Body therapy versus treatment as usual among Danish veterans with PTSD: Study protocol for a randomised controlled trial combined with a qualitative study

Contemp Clin Trials Commun. 2020 Jun 20:19:100596. doi: 10.1016/j.conctc.2020.100596. eCollection 2020 Sep.

Abstract

Background: Many veterans suffer from Post-Traumatic Stress Disorder (PTSD) after returning from military missions. This implies complex physical and psychosocial problems for veterans and their families. Treatment options today are primarily medically and psychologically founded but treatment response is incomplete. Body therapy for PTSD is scarcely researched though subject of increased attention. In 2015, a Danish pilot study was conducted exploring body therapy for PTSD. The study showed positive results and formed basis for a randomised controlled trial. This paper outlines the protocol for this trial.

Methods: The intervention will be evaluated in a two-arm randomised controlled trial (1:1). The trial will include 42 veterans with PTSD recruited by the Danish Military Psychiatric Centre. The intervention group receives treatment as usual and weekly body therapy treatment as add-on. The control group receives treatment as usual (TAU). Participants will complete four questionnaires assessing PTSD, depression, quality of life, function level and body awareness: at baseline, and at 3 months, 6 months and 12 months post baseline. Linear regression models and mixed effects models will be used to assess intervention effects. Furthermore, an ethnographic study will examine how the participants experience the treatment and changes in their everyday life. The ethnographic study is based on in-depth interviews, participant observations and focus groups. A mixed method, convergent parallel design will be applied.

Discussion: This study examines the efficacy of body therapy for veterans with PTSD and how the treatment is experienced and affects daily life. The study will contribute with important knowledge on an alternative treatment for PTSD.

Trial registration: ClinicalTrials.gov Identifier: NCT03777800.

Keywords: Body therapy; Denmark; Mixed methods; PTSD; Randomized controlled trial; Veterans.

Associated data

  • ClinicalTrials.gov/NCT03777800