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

NCT07285161 | Completed

• 2 other identifiers: RvA_PTCZN_NL72664.068.20NL72664.068.20
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

Veterans; Post Traumatic Stress Disorder; Positive Health; Recovery; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

Positive Health dialogue tool

Behavioral: Positive Health dialogue tool

Control group

NO INTERVENTION

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Reinier van Arkel: lead

Study Sites (1)

Reinier van Arkel, Psychotraumacentrum Zuid-Nederland

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

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Drs.

Model Details: 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.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)