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| ID | Type | Description | Link |
|---|---|---|---|
| NL-010470 | Registry Identifier | METC Amsterdam |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| REFRESH - monitoring | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome Questionnaire (OQ-30.2) | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinai Center | Recruiting | Amstelveen | North Holland | 1186 AM | Netherlands |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2026 | Jun 11, 2026 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 30, 2026 | Jun 11, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000077252 | Dialectical Behavior Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Multiple baseline design
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| Alcohol Use Disorders Identification Test (AUDIT) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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 |