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Hybrid Dialectical Behavior Therapy for Veterans to Further Reduce Emotion Regulation Problems and Trauma Symptoms

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07652645
Acronym
REFRESH
Enrollment
24
Registered
2026-06-17
Start date
2026-06-01
Completion date
2028-10-01
Last updated
2026-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotion Regulation Disorders, PTSD, Substance Abuse

Keywords

Emotional dysregulation, PTSD, DBT, Hybrid DBT, Veterans

Brief 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. 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.

Interventions

BEHAVIORALHybrid 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.

Sponsors

Arkin
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Multiple baseline design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
PTSD Checklist for the DSM-5 (PCL-5)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)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.

Secondary

MeasureTime frameDescription
REFRESH - monitoringFrom enrollment to (favourably) the end of the follow-up period (between 12-17 months)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.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 18, 2026