Clinical Trials Directory

Trials / Completed

CompletedNCT07285161

Evaluating the Impact of a Positive Health Dialogue Tool in Veterans With PTSD: A Randomised Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
44 (actual)
Sponsor
Reinier van Arkel · Academic / Other
Sex
All
Age
18 Years – 64 Years
Healthy volunteers
Not accepted

Summary

The primary outcome is quality of life, with secondary outcomes including PTSD symptoms, and psychosocial functioning. We hypothesise that a low-dose intervention based on empowerment and self-directed goal setting will lead to (a) measurable improvements in veterans' quality of life and (b) reduced PTSD symptoms, and improved psychosocial functioning.

Detailed description

Background: Veterans with post-traumatic stress disorder (PTSD) often experience complex and persistent symptoms that extend beyond the scope of trauma-focused treatments. The Positive Health framework offers an integrative approach to health and well-being, yet its application in veteran populations remains unexplored. This randomized controlled trial investigated the effects of integrating the Positive Health dialogue tool into trauma-focused treatment for veterans with PTSD. The study aimed to evaluate its impact on recovery indicators, including quality of life, PTSD symptoms, and psychosocial functioning. Methods: Forty-four veterans diagnosed with PTSD were randomly assigned to either a treatment group, which received two additional sessions using the dialogue tool alongside standard trauma-focused therapy, or a control group receiving treatment as usual. Outcomes were measured at baseline, 6 months, and 12 months using validated instruments, including the MANSA, PCL-5, and TRACK 2.0. Results: Although both groups showed improvements over time in PTSD symptoms and psychosocial functioning, there were no statistically significant differences found between the treatment and control groups across various recovery indicators. Conclusions: The limited scope, lack of iintegration, and timing of the intervention may have contributed to the absence of measurable effects. While the dialogue tool did not yield additional benefits beyond standard treatment, the findings underscore the need for more structured, integrated, and timely recovery-oriented interventions. Trial registration: The study was approved by the Medical Ethics Committee of Maastricht University (METc azM/UM) and registered under number NL72664.068.20 on July 7, 2020. This study was funded by the Dutch National Care System for Veterans (Landelijk Zorgsysteem voor Veteranen, LZV), which supports research aimed at improving mental health care for military veterans in the Netherlands. Corresponding author: Drs. M.M.P.A. (Maarten) Muskens: Psychotraumacentrum Zuid-Nederland; address: Bethaniestraat 10, 5211JL 's- Hertogenbosch, The Netherlands; phone: 0031 73 658 64 00; email: Maarten. Muskens@reiniervanarkel.nl

Conditions

Interventions

TypeNameDescription
BEHAVIORALPositive Health dialogue toolThis intervention is distinguished by the integration of a structured dialogue tool in two additional sessions, designed to enhance therapeutic engagement and reflection. Unlike standard trauma-focused therapy alone, this approach offers a unique combination of conventional treatment with a targeted communication strategy tailored to veterans with PTSD.

Timeline

Start date
2020-12-01
Primary completion
2024-09-01
Completion
2025-09-01
First posted
2025-12-16
Last updated
2025-12-16

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT07285161. Inclusion in this directory is not an endorsement.