Skip to content

Optimizing exposure therapy for Posttraumatic Stress Disorder

Optimizing exposure therapy for Posttraumatic Stress Disorder - OPEN up

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54936
Enrollment
180
Registered
2020-08-01
Start date
2020-11-17
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

PTSD

Interventions

Irrespective of group allocation, participants will receive one 90-minute exposure session. The control group will receive *standard exposure*, that is, exposure as it is currently delivered in rout
2) increasing fear and stimulus variability
3) increasing context variability.

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: A. Satisfying DSM-5 defined criteria for Post-Traumatic Stress Disorder B. One specific memory related to the index trauma C. Age between 18 and 70 years

Exclusion criteria

Exclusion criteria: A. Entry of patients with other psychiatric disorders will be permitted in order to increase accrual of a clinically relevant sample; however, in cases where PTSD is not judged to be the predominant disorder, participants will not be eligible. B. Current psychotherapeutic trauma-focused treatment (e.g. exposure; EMDR) C. Patients with significant suicidal ideations or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from participation. D. Mental retardation E. Substance or alcohol dependence F. Somatic illness that interfere with exposure interventions or planned assessments (e.g. cardiac conditions) G. Pregnancy H. Participants that use psychotropic medication will not be excluded but have to be on a stable dose for at least 6 weeks prior to enrollment. I. Participants that cannot commit to refraining from using sedative medication/alcohol on the days of the intervention and testing. J. Insufficient ability to speak and write Dutch

Design outcomes

Primary

MeasureTime frame
The main outcome will be change from baseline to one week follow-up in subjective fear (i.e. Subjective Units of Distress; SUDs) and physiological fear responses (i.e. heart rate and skin conductance) during a personalized trauma-script.

Secondary

MeasureTime frame
Secondary study outcomes will be change from baseline to one week follow-up in: • Avoidance behavior • Self-reported PTSD symptoms over the past week (with the PCL-5). Long-term effect of the intervention on symptoms (i.e. PTSD symptoms) will be explored at the three month follow-up (T4).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)