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

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.

Study Overview

• Status: Completed
• Conditions: PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Positive Health dialogue tool

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

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • North Brabant
    • 's-Hertogenbosch, North Brabant, Netherlands, 5211LJ
      • Reinier van Arkel, Psychotraumacentrum Zuid-Nederland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group; Positive Health dialogue tool	Behavioral: Positive Health dialogue tool; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Quality of Life Scores from Baseline, 6 Months, and 12 Months as Measured by the MANSA Questionnaire	From enrollment to 12 months post-enrollment

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in PTSD Symptom Severity from Baseline, 6 Months, and 12 Months as Measured by the PCL-5 Questionnaire	rom enrollment to 12 months post-enrollment
Change in Psychosocial Functioning from Baseline, 6 Months, and 12 Months as Measured by the TRACK 2.0 Questionnaire	From enrollment to 12 months post-enrollment

Collaborators and Investigators

• Sponsor: Reinier van Arkel

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Recovery; Veterans; Post Traumatic Stress Disorder; Randomised Controlled Trial; Positive Health
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Combat Disorders
• Other Study ID Numbers: RvA_PTCZN_NL72664.068.20; NL72664.068.20 (Other Identifier: METc Maastricht University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The datasets generated during and/or analysed during the current study will be stored in a nonpublicly available repository en will be available upon request from the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No