Hybrid Dialectical Behavior Therapy for Veterans to Further Reduce Emotion Regulation Problems and Trauma Symptoms (REFRESH)
11 juni 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Werving
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
24
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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North Holland
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Amstelveen, North Holland, Nederland, 1186 AM
- Werving
- Sinai Center
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Contact:
- Kathleen Thomaes, Senior researcher
- Telefoonnummer: 020 545 7200
- E-mail: refreshonderzoek@sinaicentrum.nl
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Contact:
- Mariejean Albers, MSc
- E-mail: mariejean.albers@sinaicentrum.nl
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Hoofdonderzoeker:
- Kathleen Thomaes, Senior researcher
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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).
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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:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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PTSD Checklist for the DSM-5 (PCL-5)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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REFRESH - monitoring
Tijdsspanne: From enrollment to (favourably) the end of the follow-up period (between 12-17 months)
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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.
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From enrollment to (favourably) the end of the follow-up period (between 12-17 months)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Outcome Questionnaire (OQ-30.2)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Alcohol Use Disorders Identification Test (AUDIT)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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Drug Use Disorders Identification Test (DUDIT)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Individual Recovery Outcome Counter (i-ROC)
Tijdsspanne: 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.
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From the baseline to the end of the follow-up period (between 12-17 months)
|
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General Self-Efficacy Scale (GSES)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Dialectical behavioral therapy skills (DBT-skills)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Level of Personality Functioning Scale (LPFS 2.0)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Inventarisatielijst Sociale Betrokkenheid (ISB)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Aggression questionnaire (AGQ)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Suicidal Ideation Attributes Scale (SIDAS)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Non-Suicidal Self-Injury Assement Tool screener (NSSI-AT screener)
Tijdsspanne: From the baseline to the end of the follow-up period (between 12-17 months)
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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.
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From the baseline to the end of the follow-up period (between 12-17 months)
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Childhood Trauma Questionnaire (CTQ)
Tijdsspanne: At baseline
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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.
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At baseline
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Medewerkers en onderzoekers
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Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juni 2026
Primaire voltooiing (Geschat)
1 september 2028
Studie voltooiing (Geschat)
1 oktober 2028
Studieregistratiedata
Eerst ingediend
23 februari 2026
Eerst ingediend dat voldeed aan de QC-criteria
11 juni 2026
Eerst geplaatst (Werkelijk)
17 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
11 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REFRESH
- NL-010470 (Register-ID: METC Amsterdam)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Very sensitive personal information.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .