Sinai Center
Amstelveen, North Holland, 1186 AM, Netherlands
Location status: Recruiting
Location contact
Kathleen Thomaes, Senior researcher
CONTACT
Kathleen Thomaes, Senior researcher
PRINCIPAL_INVESTIGATOR
Mariejean Albers, MSc
CONTACT
NCT Number: NCT07652645
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Amstelveen, North Holland, 1186 AM, Netherlands
Location status: Recruiting
Kathleen Thomaes, Senior researcher
CONTACT
Kathleen Thomaes, Senior researcher
PRINCIPAL_INVESTIGATOR
Mariejean Albers, MSc
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Arkin
Industry
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
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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