Hybrid Dialectical Behavior Therapy for Veterans to Further Reduce Emotion Regulation Problems and Trauma Symptoms (REFRESH)
11 juni 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
24
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
North Holland
-
Amstelveen, North Holland, Nederländerna, 1186 AM
- Rekrytering
- Sinai Center
-
Kontakt:
- Kathleen Thomaes, Senior researcher
- Telefonnummer: 020 545 7200
- E-post: refreshonderzoek@sinaicentrum.nl
-
Kontakt:
- Mariejean Albers, MSc
- E-post: mariejean.albers@sinaicentrum.nl
-
Huvudutredare:
- Kathleen Thomaes, Senior researcher
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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).
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PTSD Checklist for the DSM-5 (PCL-5)
Tidsram: 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)
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
REFRESH - monitoring
Tidsram: 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)
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Outcome Questionnaire (OQ-30.2)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2026
Primärt slutförande (Beräknad)
1 september 2028
Avslutad studie (Beräknad)
1 oktober 2028
Studieregistreringsdatum
Först inskickad
23 februari 2026
Först inskickad som uppfyllde QC-kriterierna
11 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- REFRESH
- NL-010470 (Registeridentifierare: METC Amsterdam)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Very sensitive personal information.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .