Post-traumatic stress symptoms in patients with chronic post-traumatic stress disorder and a comorbid psychotic disorder in the schizophrenia spectrum Mental and Behavioural Disorders Post-traumatic stress disorder
Conditions
Interventions
Participants are randomly assigned to one of four arms. Randomization is conducted by the independent randomisation bureau of Parnassia Psychiatric Institute with the use of block randomisation with t
Sponsors
Vrije Universiteit Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 16+ years 2. A lifetime diagnosis of a psychotic disorder in the schizophrenia spectrum, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) 3. Full DSM-5 diagnostic criteria for chronic PTSD on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a minimum score =23 4. Willingness to undergo randomisation and a trauma-focused therapy
Exclusion criteria
Exclusion criteria: 1. Changes in antipsychotic or antidepressant medication regimen within 4 weeks before the inclusion interview assessment (to control for medication effects) 2. Insufficient competence in the Dutch language 3. Severe intellectual impairment, defined as an estimated IQ of 70 or less 4. Not being able to travel (or be accompanied) to the outpatient service 5. Not willing or able to learn to use a smartphone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Researcher-rated changes in severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). This will be measured at baseline, at 7 weeks (mid-treatment), 13 weeks (post-treatment), 6-month follow-up, 12-month follow-up, and 24-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in the number of participants fulfilling the diagnostic criteria of PTSD - CAPS-5 2. Self-rated severity of PTSD symptoms, measured using PTSD Checklist for the DSM-5 (PCL5) 3. Severity of complex PTSD symptoms, measured using International Trauma Questionnaire (ITQ) 4. Posttraumatic cognitions, measured using Brief version of the Posttraumatic Cognitions Inventory (PTCI-9) 5. Dissociation, measured using Trait State Dissociation Questionnaire short version (TSDQ-s) 5. Depression symptoms, measured usingBeck Depression Inventory II (BDI-II) 6. Paranoia, measured using Green et al. Paranoid Thought Scales (GPTS) 7. Auditory verbal hallucinations, measured using Psychotic symptoms rating scales (PSYRATS) & Voice Impact Scale (VIS) 8. Disruption of social functioning by PTSD symptoms, measured using ITQ 9. Resilience, measured using Brief Resilience Scale (BRS) 10. Personal recovery, measured using Questionnaire about the Process of Recovery (QPR) 11. Sexual functioning, measured using Arizona Sexual Experience Scale (ASEX) & Sexual Autonomy Scale (SAS) 12. Social functioning measured with 2 items adapted from the Time Use Survey 13. Adversities measured using the 7-item TTIP Adverse Events Questionnaire 14. Revictimization, measured using Trauma and Life Events Checklist (TALE) Measures 1-11 will be measured at baseline, at 7 weeks (mid-treatment), 13 weeks (post-treatment), 6-month follow-up, 12-month follow-up, and 24-month follow-up. Measures 12-14 will be measured weekly from baseline until 6-month follow-up. | — |
Countries
Netherlands
Outcome results
None listed