1. A frequency of two sessions per week is more effective than a frequency of one session per week. 2. Treatment type (EMDR vs.) ImRs moderates the frequency effect. 3. The frequency effect is mediated by memory, relationships and motivational…
ID
Bron
Verkorte titel
Aandoening
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.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
CAPS-5 total severity score, assessed at 24 weeks after start of treatment
Achtergrond van het onderzoek
This international randomized clinical trial (RCT) investigates the effects of frequency of treatment sessions of Imagery Rescripting (ImRs) and EMDR as treatments of PTSD due to childhood trauma. Participants are randomized to ImRs or EMDR (both 12 sessions), either twice a week, or once a week a session (2x2 design). The primary outcome is change in PTSD severity as assessed with the CAPS-5. Various secondary measures are assessed, including guilt, shame, and anger. Factors that might explain an effect of session frequency are investigated both among patients and therapists. We will also develop an index that predicts which patient is better off with what treatment, frequency, or treatment-frequency combination (personalized medicine). There are 11 participating sites, 2 Australian, 3 German, and 6 Dutch sites (2 of the academic network PsyQ-UvA; 1 of GGZ Oost-Brabant; 1 of GGZ-NHN; 1 of Sinaï Centrum; 1 of ABATE). Total minimum N = 220, possibly N=280.
Senior researchers:
Arnoud Arntz (UvA); Thomas Ehring (LMU, München); Eva Fassbinder (UKSH, Lübeck); Chris Lee (UWA, Perth); Nexh Morina (WWU, Münster)
Note that ethical approval has been obtained from the ethical committee of the University of Amsterdam for the Dutch sites. German and Australian sites are in the process of obtaining ethical approval from local ethical committees.
Doel van het onderzoek
1. A frequency of two sessions per week is more effective than a frequency of one session per week.
2. Treatment type (EMDR vs.) ImRs moderates the frequency effect.
3. The frequency effect is mediated by memory, relationships and motivational facors in both patient and therapist.
Onderzoeksopzet
baseline
6-8 weeks (i.e., post resp. halfway treatment for high resp. low frequency arms)
12-16 weeks (i.e., post treatment for low frequency)
24 weeks
52 weeks
there might be an additional pre-wait assessment if natural waitlist is > 5 weeks at the participating site.
Onderzoeksproduct en/of interventie
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
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6965 |
| NTR-old | NTR7153 |
| Ander register | Ethics Review Board (FMG-UvA) University of Amsterdam : 2017-CP-8638 |