The primary objective is to determine the effects of iPE on the PTSD diagnosis, on the self-rated and clinician-rated severity of PTSD symptoms. The secondary objectives are to determine the effects on psychotic symptoms, depression symptoms,…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome is self-rated changes in severity of PTSD symptoms on the PTSD
checklist for DSM 5 (PCL-5) and clinician-rated PTSD symptoms and diagnosis
measured with the Clinician-Administered PTSD Scale (CAPS-5).
Secondary outcome
- Self-reported psychotic symptom severity, measured with the Community
Assessment of Psychic Experiences (CAPE)-42.
- Self-reported paranoia severity, measured with the Revised Green et al.
Paranoid Thought Scales (R-GPTS).
- Self-reported hallucination severity, measured with the modified Launay Slade
Hallucination Scale (LSHS).
- Self-reported depression symptom severity, measured with the Inventory of
Depressive Symptomatology - SR (IDS-SR).
- Self-reported general functioning, measured with the Outcome Questionnaire
(OQ-45).
- Self-reported treatment safety, monitored with self-report of adverse events
(e.g. suicide attempt, self-harm, aggressive behavior, problematic alcohol/drug
abuse, crisis contact with mental health care, psychiatric hospitalization).
- Subjective experienced burden, measured in an ecologically valid manner,
using a questionnaire with an 11-point Likert-scale and additional open-ended
questions.
Background summary
Studies show positive effects of prolonged exposure (PE) treatment on
posttraumatic stress disorder (PTSD) and beneficial side effects on psychosis
in patients with both PTSD and psychosis. Intensive prolonged exposure therapy
(iPE) is a relatively new strategy to deliver trauma focused treatment sessions
in a highly intense format and therefore shorter duration compared to regular
PE, resulting in a low drop-out and fast symptom reduction. However, little is
known about the effects of this iPE on PTSD and psychotic symptoms in the
patient group.
Study objective
The primary objective is to determine the effects of iPE on the PTSD diagnosis,
on the self-rated and clinician-rated severity of PTSD symptoms. The secondary
objectives are to determine the effects on psychotic symptoms, depression
symptoms, general functioning, experienced burden and treatment safety
Study design
The study design is a within-subject, time-series design in which all subjects
will receive the same intervention (iPE). Before iPE starts, subjects are
randomized to varying baseline length (3 to 9 weeks). The post-treatment phase
varies in length as well in such a way that baseline, intervention phase and
post-treatment together equal 18 weeks. Self-reported PTSD and psychotic
symptoms will be weekly measured during these 18 weeks (as well as during a
follow-up phase (four-weekly measurements) after 3 months. Furthermore, the
clinician administered PTSD symptom severity and diagnosis, self-rated
psychotic symptoms (hallucinations and paranoid thoughts), self-rated
depression symptom severity and self-rated general functioning secondary were
measured at 3 single time points: at baseline (right before the start of the
treatment), posttreatment (at the end of the iPE therapy;) and at 3-month
follow-up. Adverse events will be measured at multiple time points during the
intervention phase and posttreatment (at the end of the iPE therapy). Expected
burden will be evaluated at the start of the iPE therapy, and experienced
burden posttreatment (at the end of the iPE therapy).
Intervention
The iPE therapy program is based on Foa*s PE protocol, but given in a highly
intensive format instead of weekly sessions. The total duration of the
intervention is 6 weeks. The intensive phase of the treatment will have a
duration of four weekdays, delivered in two weeks. After the intensive phase,
the subject will participate in the booster phase in which the subject will
receive a 90-minute PE booster session weekly over the next four weeks.
Study burden and risks
Prior research shows that iPE programs are safe. Worsening of symptoms or other
adverse events are not expected. Furthermore, patient follow up-care as usual
is embedded. During and after the study subjects will continue their regular
psychosis treatment.
Velperweg 26
Arnhem 6824 BJ
NL
Velperweg 26
Arnhem 6824 BJ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1) a minimum age of 18 years;
2) a diagnosis of PTSD that meets the criteria of the DSM-5 (American
Psychiatric Association, 2013) measured with the Clinician-Administered PTSD
Scale (CAPS-5; Weathers, Keane, & Davidson, 2001; Weathers, et al., 2018) and;
3) a co-morbid current diagnosis of a psychotic disorder according to the
Mini-International Neuropsychiatric Interview-S (MINI-S) (Sheehan, et al.,
1998)
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1) high acute suicide risk, characterized as a suicide attempt within the past
2 months;
2) changes in antipsychotic or antidepressant medication within two months
before the start of this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75271.091.21 |