PTSD due to trauma(s) that took place before the age of 16. PTSS t.g.v. van trauma's die plaatsvonden in de kindertijd, voor de leeftijd van 16 jaar.
Conditions
Interventions
EMDR, 12 sessions, delivered once a week
EMDR, 12 sessions, delivered twice a week
ImRs, 12 sessions, delivered once a week
ImRs, 12 sessions, delivered twice a week
Sponsors
University of Amsterdam, Netherlands;University of Western Australia, Australia;University of Munich, Germany;University of Münster, Germany;University of Lübeck, Germany;Hunter New England Mental Health Service, Newcastle, Australia;Sexual Assault Resource Centre, Perth, Australia; PsyQ Amsterdam, Beverwijk, the Netherlands;GGZ Oost-Brabant, Helmond, the Netherlands;GGZ Noord-Holland Noord, Heerhugowaard, the Netherlands;Sinai Center, Amstelveen, the Netherlands; ABATE, Enkhuizen, the Netherlan
Eligibility
Inclusion criteria
Inclusion criteria: - PTSD as defined by the DSM-5, assessed with the SCID-5-CV or SCID-5-RV and the CAPS. - PTSD as main complaint - Duration of PTSD > 3 months. - Index trauma happened before the age of 16 - patient agrees that index trauma is focus of treatment - If a recent trauma occurred: recent trauma happened more than 6 months ago - Age between 18 and 70 - Ability to understand, read, write and speak country's language. In German and Dutch sites the English language is also possible, if the site has research assistants and therapists of both conditions that are sufficiently fluent in English.
Exclusion criteria
Exclusion criteria: - Acute PTSD - DSM-5 substance use disorder, severity level moderate or severe (defined by 4 or more symptoms). (After 6 weeks of abstinence participation is possible). - Use of benzodiazepine (patients are motivated to stop benzodiazepine use in order to follow treatment protocol) (After 2 weeks of abstinence participation is possible) - Comorbid psychotic disorder - DSM-5 Bipolar disorder, type 1 (current or past) - Acute suicide risk - IQ < 80 - Serious neurological problems like dementia - Scheduled to begin another form of PTSD treatment - PTSD focused therapy within the past 3 months. If patients are in treatment for PTSD, there should be a 3-months treatment free period before they can participate in the study. PTSD-focused treatment includes emotion-regulation treatments for PTSD like STAIR and other PTSD-focused treatments, but not general supportive treatments. - Patients should not start with any form of psychological treatment or medication during screening or during the study's treatment or waitlist period. Medication should be on a stable level for 3 months, if not stopped. (Non-PTSD focused supportive treatment may be continued during wait and screening, but not during the study treatment and study post-treatment follow-up period (i.e., up to the 24 weeks assessment). - Not able to plan 12 sessions of 90 minutes within 6 to 8 weeks (time in between the sessions needs to be at least 2 days), or 12 sessions within 12 to 16 weeks (time in between sessions needs to be at least 6 days and on the average a week or longer). COVID-19 related ad hoc exclusion of participants that could not be seen face-to-face during all their treatment sessions. The research into factors explaining the possible superiority of the twice-a-week treatment require face-to-face treatment because of the pre-session assessment procedures of patients and therapists. The (temporary) closure of mental health institutes in Australia, Germany, and the Netherlands, has lead the study board to take this decision. Moreover, because of excluding these participants, and the slowing down of recruitment during the pandemic, the stop date has been provisionally extended with at least a year. Because of capacity problems 3 PsyQ sites did not start participation, only the Amsterdam and Beverwijk PsyQ sites participate. To compensate, the ABATE mental health institute joined the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CAPS-5 total severity score, assessed at 24 weeks after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Self-reported PTSD-symptoms are assessed with the PCL, at every assessment as well as at start of every session (Weathers et al., 2013). The time frame in the instruction of the PCL will be changed from “in the past month” to “in the past week”. Seven items are added to the PCL to assess shame, anger, guilt, disgust, sadness, anxiety and happiness (see Arntz et al., 2007). Therapists can use these ratings to steer the treatment. 2. Depression will be assessed with the BDI-II (Beck, Steer, & Brown, 1996; Van der Does, 2002), a 21-item self-report instrument assessing depressive symptoms during the last two weeks. 3. PTSD-related cognitions: the PTCI, a self-report instrument, is used to assess trauma related cognitions (Foa et al, 1999). 4. Guilt and Shame will be assessed with a new instrument developed on the basis of the PFQ2 & ASGS, with 8 items to assess how often the participant experienced feelings of guilt amd shame (Harder & Zalma, 1990). 5. Anger will be assessed with the Self-Expression and Control Scale (SECS) (van Elderen et al., 1996, 1997; Dutch: Zelfexpressie en –controle vragenlijst, ZECV; van Elderen et al., 1995), and with the hostility subscale of the Symptom Checklist-90-Revised (SCL-90, Arrindel & Ettema, 1986; Derogatis, 2010). 6. General, social and societal functioning will be assessed with the WHODAS, taken by the research assistant who is blind for condition (WHO, 2000; 2001). 7. Learned Helplessness is assessed with the DAQ (Kleim et al., 2011). 8. Happiness is assessed with the 1-item happiness question validated in more than 30 countries (Veenhoven, 2011) 9. Dissociative experiences will be assessed with the Dissociative Experiences Scale Taxon (DES-T; Waller, Putnam, & Carlson, 1996) 10. Medication use will be monitored during treatment and at each assessment. 11. Vividness, valence and encapsulated belief(s) will be assessed by having the participants rate these aspects on 0-100% scales immediately after shortly imagini | — |
Contacts
Public ContactArnoud Arntz
University of Amsterdam
Outcome results
None listed