Posttraumatic stress disorder Mental and Behavioural Disorders Posttraumatic stress disorder
Conditions
Interventions
Current interventions as of 14/01/2020:
In this study, the design is a randomised controlled trial (RCT) by blocked randomisation. If a participant meets inclusion criteria a baseline assessment, pre
Heart rate (HR), Heart Rate Variability (HRV) and Pre-ejection (PEP) responses to trauma-related stimuli. Secondary outcomes of the study are change of cortisol level and reduction in PTSD symptoms b
Sponsors
BUDI LN_LPDP (Indonesian Scholarship)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 14/01/2020: 1. Diagnostic and Statistical Manual of Mental Disorder, fifth edition (DSM-5) diagnosis of PTSD as diagnosed with the Structured Clinical Interview for DSM-5 disorders (SCID-5) 2. Age of 18 years or older ______ Previous inclusion criteria: 1. Individuals who were either diagnosed posttraumatic stress disorder (PTSD) by a professional, i.e., by a clinical psychologist and meet DSM-V-TR, the diagnostic rule which requires at least one criteria of A, B, and C and at least two criteria of D and E and with cut off 33 of PCL-5 score 2. Suffering from posttraumatic stress symptoms on a subclinical level with one symptom in each criterion of PTSD symptoms and with cut off 20 of PCL-5 score 3. Minimal age of 18 years
Exclusion criteria
Exclusion criteria: Current inclusion criteria as of 14/01/2020: 1. Current or previous psychotic disorder 2. Current substance use disorder 3. Acute suicidality 4. Current organic disorder i.e. epileptic, brain damage _____ Previous exclusion criteria: 1. Individuals with current organic disorders, psychotic disorders, substance abuse, or suicidal ideation will be excluded 2. Individuals that are currently taking any medication for psychological or psychiatric disorders are excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 14/01/2020: Heart Rate Variability (HRV) measured using the VU AMS device at baseline (T0), during intervention (T1), post-treatment (T2) and six months follow up (T3) _____ Previous primary outcome measure: 1. Heart Rate (HR)/Heart Rate Variability (HRV) is measured using the VU AMS device at baseline (T0), during intervention (T1), post-treatment (T2) and six months follow up (T3) 2. Pre-ejection period (PEP) is measured using the VU AMS device at baseline (T1), during intervention (T1), post-treatment (T2) and 6 months follow up (T3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/01/2020: At baseline (T0), during intervention (T1), post-treatment (T2) and 6 months follow up (T3): 1. Heart Rate (HR) measured using the VU AMS device 2. Pre-ejection period (PEP) measured using the VU AMS device 3. Diagnosis of DSM-5 Axis I disorder using the SCID-5 questionnaire 4. PTSD symptoms using the PCL-5 5. Experiences of traumatic events using Live Events Checklist (LEC) 6. Anxiety and depression symptoms using The Hopkins Symptoms Checklist-25 (HSCL-25) 7. Perceived feelings and thought of stress during the last month using The Perceived Stress Scale (PSS) 8. Quality of life using the Indonesian version of the World Health Organization Quality of Life (WHOQOL-BREF) 9. Neurocognitive Functioning using the Digit Span subtest of the Indonesian WAIS-IV 10. Encoding, short-term retrieval, and recognition of verbal information using The California Verbal Learning Test (CVLT) 11. Information processing speed, shift of attention, planning, and cognitive ?exibility using The Trail Making Test (TMT) _____ Previous secondary outcome measures: 1. Cortisol level is measured using salivary samples using The Salimetrics Cortisol Enzyme Immunoassay Kit at baseline (T0), post-treatment (T2) and six months follow up (T3) 2. PTSD symptom score is measured using CAPS (Clinican Administered PTSD Scale) at baseline (T0), post-treatment (T2) and 6 months follow up (T3) 3. PTSD symptom score is measured using PTSD Checklist for DSM-5 at baseline (T0), post-treatment (T2) and six months follow up (T3) | — |
Countries
Indonesia
Outcome results
None listed