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TEMPO trial: Trauma-focused Exposure with Motion for Posttraumatic stress disorder

TEMPO trial: Trauma-focused Exposure with Motion for Posttraumatic stress disorder - TEMPO trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53394
Enrollment
182
Registered
2023-08-30
Start date
2023-11-27
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Posttraumatic Stress Disorder PTSD

Interventions

Participants in both VR exposure conditions receive at least 9 weekly treatment sessions, including two preparatory treatment sessions, six VR exposure sessions, and one concluding session. Based on

Sponsors

GGZ Drenthe (Assen)
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1) PTSD diagnosis established by the Clinician-Administered PTSD scale for DSM-5 (CAPS-5) 2) age 18 years or older 3) sufficient mastery of the Dutch language to perform the assessments 4) be able to keep a stable dose of psychotropic medication between four weeks before entering the trial and until the first follow-up assessment, three months post treatment (F4).

Exclusion criteria

Exclusion criteria: 1) unable to walk for approximately one hour 2) a high acute risk of suicidality 3) hospitalized in the past three months due to severe psychiatric conditions (e.g., severe self-injury, acute florid psychotic symptoms or severe eating disorder 4) report high levels of acute dissociative amnesia (memory gaps) which might prevent them to store new, corrective information from the trauma-focused treatment session 5) severe substance use disorder which needs specialized treatment 6) uses substances and cannot adhere to the agreement of not being under the influence of addictive substances during treatment.

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter is PTSD severity over time, measured with Clinical-Administered PTSD Scale for DSM-5 (CAPS-5).

Secondary

MeasureTime frame
Secondary outcome parameters are trauma-related avoidance and general avoidance tendencies. Moreover, self-reported PTSD symptoms, depressive- and dissociative symptoms, treatment expectancy and engagement, and heart and respiration rate during VR exposure sessions will be measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)