Hybrid Dialectical Behavior Therapy for Veterans to Further Reduce Emotion Regulation Problems and Trauma Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArkin
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Hybrid dialectical behavior therapy
BehavioralHybrid 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Hybrid DBTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From the baseline to the end of the follow-up period (between 12-17 months)2
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.
Time frame
From the baseline to the end of the follow-up period (between 12-17 months)Secondary outcomes
1
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.
Time frame
From enrollment to (favourably) the end of the follow-up period (between 12-17 months)Other outcomes
1
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.
Time frame
From the baseline to the end of the follow-up period (between 12-17 months)2
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.
Time frame
From the baseline to the end of the follow-up period (between 12-17 months)3
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.
Time frame
From the baseline to the end of the follow-up period (between 12-17 months)4
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.
Time frame
From the baseline to the end of the follow-up period (between 12-17 months) Source ClinicalTrials.gov