PTSDREFRESHNCT07652645
Hybrid Dialectical Behavior Therapy for Veterans to Further Reduce Emotion Regulation Problems and Trauma Symptoms
A study testing Hybrid dialectical behavior therapy in people with PTSD and Emotion Regulation Disorders, run by Arkin at 1 site in Netherlands.
Trial summary
Around 10% of post-active veterans experience post-traumatic stress disorder (PTSD) many years post-mission. PTSD in veterans is frequently associated with challenges in emotion regulation, aggression, suicidality, and financial and psychosocial stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Emotion Regulation Disorders, Substance Abuse
- What is being tested?
- Hybrid dialectical behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2026to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult veteran (18 years or older), treated at Sinai Center, with knowledge of DBT
- Primairy diagnosis of PTSD, determined with CAPS-5, resulting from war-related traumas
- Stable for four weeks on their medication (type and doses)
- Able to to do online homework assignments and communicate with their therapist via an eHealth platform
- Dutch speaking
Who cannot join
- Chronic psychosis (psychotic features as comorbidity from PTSD is allowed) or bipolar disorder type 1
- IQ below 80 or cognitive disorders
- Severe self-harming behaviour, such as auto-mutilation or suicidal ideations as main problem
- Following day treatments or other intensive treatment for residual symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Sinai Center
Amstelveen, North Holland, 1186 AM
Kathleen Thomaes, Senior researcher, 020 545 7200, refreshonderzoek@sinaicentrum.nl
Mariejean Albers, MSc, mariejean.albers@sinaicentrum.nl
About this study
Official title: REfreshment of Dialectical Behaviour Therapy for Veterans to Further Reduce Symptoms and Prevent Relapse of Post-traumatic Stress Disorder and Emotion Regulation Symptoms by Guided Self-Help
Around 10% of post-active veterans experience post-traumatic stress disorder (PTSD) many years post-mission. PTSD in veterans is frequently associated with challenges in emotion regulation, aggression, suicidality, and financial and psychosocial stress. In 2018, a 12-week clinical treatment programme, the Veterans Intensive Treatment Unit (VIBU), was developed for veterans experiencing these psychiatric symptoms, for whom conventional treatments had proven ineffective. The VIBU provides patients with trauma-focused and dialectical behaviour therapy (DBT). A recent study revealed that the VIBU was effective in reducing psychiatric symptoms. However, a recurrence of symptoms was observed in patients a few months after discharge. Consequently, an aftercare programme consisting of hybrid DBT is offered to consolidate and repeat the DBT skills and apply them in daily life.
- Conditions
- PTSD, Emotion Regulation Disorders, Substance Abuse
- Being tested
- Hybrid dialectical behavior therapy
- Keywords
- Emotional dysregulation, PTSD, DBT, Hybrid DBT, Veterans
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid dialectical behavior therapyBehavioural
Also called DBT, Dialectical behavior therapy
Hybrid DBT will be provided to veterans who have followed a 3-month inpatient DBT treatment. The hybrid DBT will include face-to-face skill groups, online individual sessions and online homework assignements.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid DBT | Experimental | All participants will follow the same hybrid DBT program (i.e., group sessions, individual sessions and online homework assignments). Randomization will determine the length of the waiting period between baseline and start of the intervention (i.e., hybrid DBT). Receives: Behavioral: Hybrid dialectical behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for the DSM-5 (PCL-5)
One of the two main outcomes of this study is PTSD symptom score. The self-report questionnaire contains 20 questions with answer options ranging from '0 = Not at all' to '4 = Extremely', resulting in a score between 0-80. A higher score indicates more likelyhood of having PTSD.
Measured: From the baseline to the end of the follow-up period (between 12-17 months)
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
One of the two main outcomes of this study is emotion dysregulation severity. The self-report questionnaire contains 18 questions with answer options from '1 = Almost never' to '5 = Almost always', resulting in a score between 18-90. A higher score indicates more difficulties with regulation emotions.
Measured: From the baseline to the end of the follow-up period (between 12-17 months)
Secondary outcomes (1)
REFRESH - monitoring
Weekly short questionnaire (i.e., 10 questions) specifically tailored to this population to monitore PTSD, emotion regulation, substance use and DBT skills. Answer options range from '1 = Totally disagree' to '10 = Totally agree', resulting in a score between 10-100. A higher score means a worse outcome.
Measured: From enrollment to (favourably) the end of the follow-up period (between 12-17 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Jun 2026
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Single group
- Model description
- Multiple baseline design
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07652645
- Sponsor's protocol ID
- REFRESH
- Other IDs
- NL-010470
- Acronym
- REFRESH
- Status last verified
- Jun 2026
- First submitted
- 23 Feb 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Very sensitive personal information.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REfreshment of Dialectical Behaviour Therapy for Veterans to Further Reduce Symptoms and Prevent Relapse of Post-traumatic Stress Disorder and Emotion Regulation Symptoms by Guided Self-Help
- ClinicalTrials.gov ID
- NCT07652645
- Acronym / sponsor ID
- REFRESH / REFRESH
- Conditions
- PTSD, Emotion Regulation Disorders, Substance Abuse
- Keywords
- Emotional dysregulation, PTSD, DBT, Hybrid DBT, Veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- ArkinIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 17 Jun 2026 (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.
Around 10% of post-active veterans experience post-traumatic stress disorder (PTSD) many years post-mission. PTSD in veterans is frequently associated with challenges in emotion regulation, aggression, suicidality, and financial and psychosocial stress. In 2018, a 12-week clinical treatment programme, the Veterans Intensive Treatment Unit (VIBU), was developed for veterans experiencing these psychiatric symptoms, for whom conventional treatments had proven ineffective. The VIBU provides patients with trauma-focused and dialectical behaviour therapy (DBT). A recent study revealed that the VIBU was effective in reducing psychiatric symptoms. However, a recurrence of symptoms was observed in patients a few months after discharge. Consequently, an aftercare programme consisting of hybrid DBT is offered to consolidate and repeat the DBT skills and apply them in daily life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple baseline design
| Arm | Type | Receives |
|---|---|---|
| Hybrid DBT | Experimental | Behavioral: Hybrid dialectical behavior therapyAll participants will follow the same hybrid DBT program (i.e., group sessions, individual sessions and online homework assignments). Randomization will determine the length of the waiting period between baseline and start of the intervention (i.e., hybrid DBT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult veteran (18 years or older), treated at Sinai Center, with knowledge of DBT
- Primairy diagnosis of PTSD, determined with CAPS-5, resulting from war-related traumas
- Stable for four weeks on their medication (type and doses)
- Able to to do online homework assignments and communicate with their therapist via an eHealth platform
- Dutch speaking
Key exclusion criteria (4 listed)
- Chronic psychosis (psychotic features as comorbidity from PTSD is allowed) or bipolar disorder type 1
- IQ below 80 or cognitive disorders
- Severe self-harming behaviour, such as auto-mutilation or suicidal ideations as main problem
- Following day treatments or other intensive treatment for residual symptoms
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 |
|---|---|---|
| Hybrid dialectical behavior therapyAlso: DBT, Dialectical behavior therapyHybrid DBT will be provided to veterans who have followed a 3-month inpatient DBT treatment. The hybrid DBT will include face-to-face skill groups, online individual sessions and online homework assignements. | Behavioural | Hybrid DBT |
Primary outcome
PTSD Checklist for the DSM-5 (PCL-5)
Time frame: From the baseline to the end of the follow-up period (between 12-17 months)
One of the two main outcomes of this study is PTSD symptom score. The self-report questionnaire contains 20 questions with answer options ranging from '0 = Not at all' to '4 = Extremely', resulting in a score between 0-80. A higher score indicates more likelyhood of having PTSD.
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Time frame: From the baseline to the end of the follow-up period (between 12-17 months)
One of the two main outcomes of this study is emotion dysregulation severity. The self-report questionnaire contains 18 questions with answer options from '1 = Almost never' to '5 = Almost always', resulting in a score between 18-90. A higher score indicates more difficulties with regulation emotions.
1 secondary outcome
REFRESH - monitoring
Time frame: From enrollment to (favourably) the end of the follow-up period (between 12-17 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Very sensitive personal information.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid dialectical behavior therapy in people with PTSD and Emotion Regulation Disorders, run by Arkin 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for the DSM-5 (PCL-5) (time frame: From the baseline to the end of the follow-up period (between 12-17 months)). The study lists 2 primary outcomes in all. 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 17 Jun 2026.