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

NCT07652645 | Recruiting

• 2 other identifiers: REFRESHNL-010470
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD; Emotion Regulation Disorders; Substance Abuse

Keywords

Emotional dysregulation; PTSD; DBT; Hybrid DBT; Veterans

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  From the baseline to the end of the follow-up period (between 12-17 months)

Secondary Outcomes (1)

• REFRESH - monitoring

  From enrollment to (favourably) the end of the follow-up period (between 12-17 months)

Other Outcomes (12)

• Outcome Questionnaire (OQ-30.2)

  From the baseline to the end of the follow-up period (between 12-17 months)

• Alcohol Use Disorders Identification Test (AUDIT)

  From the baseline to the end of the follow-up period (between 12-17 months)

• Drug Use Disorders Identification Test (DUDIT)

  From the baseline to the end of the follow-up period (between 12-17 months)

Study Arms (1)

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).

Behavioral: Hybrid dialectical behavior therapy

Interventions

Hybrid dialectical behavior therapy BEHAVIORAL

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.

Also known as: DBT, Dialectical behavior therapy

Hybrid DBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arkin: lead

Study Sites (1)

Sinai Center

Amstelveen, North Holland, 1186 AM, Netherlands

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple baseline design

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)