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IPE for PTSD in patients with a psychotic disorder

Intensive prolonged exposure therapy for posttraumatic stress disorder in patients with a psychotic disorder: a single trial design - IPE for PTSD in patients with a psychotic disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51923
Enrollment
10
Registered
2021-07-30
Start date
2022-12-05
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1) PTSD (2) trauma

Interventions

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 th

Sponsors

Pro Persona
Lead Sponsor

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: 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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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.

Countries

Netherlands

Contacts

Public ContactM Laarhoven

GGZ Oost Brabant

m.van.laarhoven@ggzoostbrabant.nl088 846 0464

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 11, 2026