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Completed

NCT Number: NCT07285161

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

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reinier van Arkel, Psychotraumacentrum Zuid-Nederland

's-Hertogenbosch, North Brabant, 5211LJ, Netherlands

About this study

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. [email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A formal PTSD diagnosis
  • At the start of treatment
  • Aged 18 until 64
  • Reading, writing, and speaking Dutch

Exclusion criteria

  • Alcohol or drug dependency
  • Severe cognitive impairments (e.g., dementia)
  • Acute suicide risk, as assessed during the intake procedure

Treatment and study plan

Positive Health dialogue tool

Behavioral

This 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.

Primary outcomes

  1. Change in Quality of Life Scores from Baseline, 6 Months, and 12 Months as Measured by the MANSA Questionnaire

    Time frame: From enrollment to 12 months post-enrollment

Secondary outcomes

  1. Change in PTSD Symptom Severity from Baseline, 6 Months, and 12 Months as Measured by the PCL-5 Questionnaire

    Time frame: rom enrollment to 12 months post-enrollment

  2. Change in Psychosocial Functioning from Baseline, 6 Months, and 12 Months as Measured by the TRACK 2.0 Questionnaire

    Time frame: From enrollment to 12 months post-enrollment

Sponsors and collaborators

Lead sponsor

Reinier van Arkel

Other

Registry information

Acronym: EIPHDT

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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