PTSD - Post Traumatic Stress DisorderEIPHDTNCT07285161
Evaluating the Impact of a Positive Health Dialogue Tool in Veterans With PTSD: A Randomised Controlled Trial
A study testing Positive Health dialogue tool in people with PTSD - Post Traumatic Stress Disorder, run by Reinier van Arkel at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Positive Health dialogue tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2020to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A formal PTSD diagnosis
- At the start of treatment
- Aged 18 until 64
- Reading, writing, and speaking Dutch
Who cannot join
- Alcohol or drug dependency
- Severe cognitive impairments (e.g., dementia)
- Acute suicide risk, as assessed during the intake procedure
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Reinier van Arkel, Psychotraumacentrum Zuid-Nederland
's-Hertogenbosch, North Brabant, 5211LJ
About this study
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.
Read the 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
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Positive Health dialogue tool
- Keywords
- Veterans, Post Traumatic Stress Disorder, Positive Health, Recovery, Randomised Controlled Trial
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Health dialogue toolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Positive Health dialogue tool Receives: Behavioral: Positive Health dialogue tool |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life Scores from Baseline, 6 Months, and 12 Months as Measured by the MANSA Questionnaire
Measured: 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
Measured: 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
Measured: From enrollment to 12 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Dec 2020
- Primary completion1 Sep 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reinier van Arkel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten Muskens, Reinier van Arkel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285161
- Sponsor's protocol ID
- RvA_PTCZN_NL72664.068.20
- Other IDs
- NL72664.068.20
- Acronym
- EIPHDT
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Positive Health Dialogue Tool in Veterans With PTSD: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07285161
- Acronym / sponsor ID
- EIPHDT / RvA_PTCZN_NL72664.068.20
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- Veterans, Post Traumatic Stress Disorder, Positive Health, Recovery, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Reinier van ArkelUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Positive Health dialogue toolPositive Health dialogue tool |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- A formal PTSD diagnosis
- At the start of treatment
- Aged 18 until 64
- Reading, writing, and speaking Dutch
Key exclusion criteria (3 listed)
- Alcohol or drug dependency
- Severe cognitive impairments (e.g., dementia)
- Acute suicide risk, as assessed during the intake procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive 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. | Behavioural | Intervention group |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Health dialogue tool in people with PTSD - Post Traumatic Stress Disorder, run by Reinier van Arkel at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.