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NCT Number: NCT07652645

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sinai Center

Amstelveen, North Holland, 1186 AM, Netherlands

Location status: Recruiting

Location contact

Kathleen Thomaes, Senior researcher

CONTACT

[email protected]

020 545 7200

Kathleen Thomaes, Senior researcher

PRINCIPAL_INVESTIGATOR

Mariejean Albers, MSc

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: DBT, Dialectical behavior therapy

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. REFRESH - monitoring

    Time frame: From 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.

Other outcomes

  1. Outcome Questionnaire (OQ-30.2)

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

    This self-report questionnaire gives an indication of overall psychiatric symptoms and entails 30 items. Answers options go from '0 = almost never' to '4 = almost alywas'. The score ranges between 0-120, with a higher score indicating a worse outcome.

  2. Alcohol Use Disorders Identification Test (AUDIT)

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

    This self-report questionnaire contains 10 items with answer options from '0 = never' to '4 = high usage', resulting in a score between 0-40. A higher score indicates having alcohol problems.

  3. Drug Use Disorders Identification Test (DUDIT)

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

    This self-report questionnaire contains 11 items with answer options from '0 = never' to '4 = high usage', resulting in a score between 0-40. A higher score indicates having drug problems.

  4. Individual Recovery Outcome Counter (i-ROC)

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

    This questionnaires measures wellbeing outcomes. This self-report questionnaire of 12 items uses answer options from '1 = Never' to '6 = Always', resulting in a score ranging between 12-72. A higher score indicates a better outcome.

  5. General Self-Efficacy Scale (GSES)

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

    This questionnaire measures self-efficacy. This self-report questionnaire of 10 items, with answer options from '1 = Not at all true' to '4 = Exactly true', with scores ranging from 10-40. A higher score indicates more self-efficacy.

  6. Dialectical behavioral therapy skills (DBT-skills)

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

    This questionnaire asks participants about their use of DBT skills. This self-report questionnaire of 17 items has answer options from '1 = never' to '5 = often', giving a score rangen between 17-85. A higher score indicates a positive outcome.

  7. Level of Personality Functioning Scale (LPFS 2.0)

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

    This questionnaire measures the level of personality functioning. This self-report questionnaire contains 12 items, with answers ranging from '1 = not often true' to '4 = often true', resulting in a score between 12-48. A higher score indicates a worse outcome.

  8. Inventarisatielijst Sociale Betrokkenheid (ISB)

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

    This questionnaire is about social wellbeing. This self-report questions contains 11 items, with results from '1 = almost never' to '4 = almost always', resulting in a score between 11-44. A higher score indicates a positive outcome.

  9. Aggression questionnaire (AGQ)

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

    This questionnaire measures different forms of aggression. This self-report questionnaire contains 29 items, with answer from '1 = Extremely uncharacteristic' to '5 = Extremely characteristic', resulting in a score between 29-145. A higher score indicates a worse outcome.

  10. Suicidal Ideation Attributes Scale (SIDAS)

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

    This questionnaire measures suicidal ideation. This self-report questionnaire contains 5 items, with answer from '0 = Not at all' to '10 = Completely', resulting in a score between 0-50. A higher score indicates a higher level of suicidal ideation.

  11. Non-Suicidal Self-Injury Assement Tool screener (NSSI-AT screener)

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

    This questionnaire measures self-injurious behavior. This self-report questionnaire contains 7 items asking about the frequency and severity of self-injurious behaviour. There is no scoring.

  12. Childhood Trauma Questionnaire (CTQ)

    Time frame: At baseline

    This questionnaire assess childhood maltreatment. This self-report questionnaire contains 28 items, with answers from '1 = Never true' to '5 = Very often true', resulting in a score between 28-140. A higher score indicate a worse outcome.

Sponsors and collaborators

Lead sponsor

Arkin

Industry

Registry information

Official study 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

Acronym: REFRESH

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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