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

11. Juni 2026 aktualisiert von: Arkin

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

24

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Hybrid DBT
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).
Verhalten: 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.
Andere Namen:
  • DBT
  • Dialectical behavior therapy

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PTSD Checklist for the DSM-5 (PCL-5)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
REFRESH - monitoring
Zeitfenster: 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.
From enrollment to (favourably) the end of the follow-up period (between 12-17 months)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Outcome Questionnaire (OQ-30.2)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Alcohol Use Disorders Identification Test (AUDIT)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Drug Use Disorders Identification Test (DUDIT)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Individual Recovery Outcome Counter (i-ROC)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
General Self-Efficacy Scale (GSES)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Dialectical behavioral therapy skills (DBT-skills)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Level of Personality Functioning Scale (LPFS 2.0)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Inventarisatielijst Sociale Betrokkenheid (ISB)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Aggression questionnaire (AGQ)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Suicidal Ideation Attributes Scale (SIDAS)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Non-Suicidal Self-Injury Assement Tool screener (NSSI-AT screener)
Zeitfenster: 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.
From the baseline to the end of the follow-up period (between 12-17 months)
Childhood Trauma Questionnaire (CTQ)
Zeitfenster: 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.
At baseline

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Arkin

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juni 2026

Primärer Abschluss (Geschätzt)

1. September 2028

Studienabschluss (Geschätzt)

1. Oktober 2028

Studienanmeldedaten

Zuerst eingereicht

23. Februar 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Juni 2026

Zuerst gepostet (Tatsächlich)

17. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

17. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

11. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • REFRESH
  • NL-010470 (Registrierungskennung: METC Amsterdam)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Very sensitive personal information.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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