Post-traumatic stress disorder
Conditions
Interventions
All treatments will be provided by trained therapists working at Jellinek and
will consist of twelve 90-minute sessions conducted twice per week.
Intervention 1: Prolonged Exposure (PE): PE involve
Sponsors
Arkin (Amsterdam)
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - age 18 years or older; - substance use disorder(s) according to the Diagnostic and Statistical Manual of Mental Disorders 5 criteria (DSM-5; American Psychiatric Association, 2013) with a primary diagnosis involving one of the following substances: alcohol, cannabis, cocaine (snorting) amphetamine, benzodiazepine, opioid. - posttraumatic stress disorder according to the DSM-5 criteria; - sufficient understanding of the Dutch language.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - acute psychotic disorder; - mental retardation or cognitive impairment (estimated IQ<70); - current physical or sexual abuse or death threats; - suicidal behavior; (A suicide attempt during the past 3 month or acute suicidal ideations according to the MINI) - life threatening self-mutilation; - homelessness. - involvement in a compensation case or legal procedures concerning admission or stay in the Netherlands - involvement in legal procedures regarding the index trauma - engagement in any other current PTSD treatment Current amendement: - Explicit indication at the baseline IC that they do not wish to be approached for future research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is severity of PTSD symptoms as measured with Clinician Administered PTSD Scale for DSM 5 (CAPS-5) (Weathers et al., 2013). The CAPS-5 is the gold standard in PTSD assessment. It is a 30-item structured interview, corresponding to the DSM-5 diagnosis for PTSD, that provides a current total severity score. Current amendment: The primary outcome of the study is violent revictimization as measured with the safety monitor, which assesses the prevalence and context details of three types of interpersonal violence, sexual abuse, threat, and physical abuse, over the past three years. It is a structured interview which has been used in the past in research on victimization and that is used annually by the central bureau for statistics in the Netherlands (CBS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured by therapist: - Completion of PTSD treatment (yes/no); - Completion of SUD treatment (yes/no); Measured with self-report questionnaire during assessments: - Psychological distress (Brief Symptom Inventory (BSI)); - Alcohol and drug use problems (Alcohol Use Disorder Identification Test (AUDIT) Drug Use Disorder Identification Test (DUDIT)); - Substance use past 30 days (MATE-Q-nl module 1) - Interpersonal problems (Inventory of Interpersonal Problems (IIP-32)); - Emotion dysregulation (Difficulties in Emotion Regulation Scale (DERS)); - Trauma-related guilt (Trauma Related Guilt Inventory (TRGI)); - Trauma-related shame (Trauma Related Shame Inventory (TRSI)); - Internalised and externalised anger and anger control (Zelf Expressie en Controle Vragenlijst (ZECV)); - Recent victimization (Veiligheidsmonitor (VM)); - Care consumption/costs (Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)); - Quality of Life (EuroQol 5D (EQ-5D-5L)). - (Recent) victimization and (recent) perpetration (minor extension of LEC-5)); Measured with experimental tasks during assessments: -Impulsivity (delay discounting task); and emotion regulation task. Measured with self-report questionnaire at start of therapy sessions: - PTSD symptoms (PTSD symptom scale -self report (PSS-SR) (every session); - Substance use in past 7 days (every session); - Working alliance (Working Alliance Inventory - short form (WAI-SF) Other study parameters - Demographic characteristics; - Complex PTSD (ITQ part 2) - Childhood trauma (Childhood Trauma Questionnaire (CTQ)); - Daily Emotional Support ((DES) subscale from Social Support Questionnaire (SSQ)); - Traumatic Life events (LEC-5); - Patient preference of type and timing of PTSD treatment; - Therapist working experience; - Therapist preference of type and timing of PTSD treatment; - Number of sessions of PTSD-treatment attended; - Number of sessions of SUD-treatment attended. Current amend | — |
Countries
Netherlands
Outcome results
None listed