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Recruiting NCT07652645

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

No phase Interventional PTSD Emotion Regulation Disorders Substance Abuse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hybrid dialectical behavior therapy.
Who it may be relevant to
Registry conditions: PTSD, Emotion Regulation Disorders, Substance Abuse. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

  • Behavioral Hybrid 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.

Primary outcome measures

  • 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)]
  • 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)]
Secondary outcome measures (1)
  • REFRESH - monitoring [Time frame: From enrollment to (favourably) the end of the follow-up period (between 12-17 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Sinai Center — Amstelveen

Identifiers

NCT: NCT07652645 · REFRESH · NL-010470

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗