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Validation of efficacy of online prolonged exposure for PTSD:a multicenter randomized controlled trial

Validation of efficacy of online prolonged exposure for PTSD:a multicenter randomized controlled trial - OPERA study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1030240132
Enrollment
24
Registered
2024-06-03
Start date
2024-06-03
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

PTSD, Post Traumatic Stress Disorder PTSD, Posttraumatic Stress Disorder, Psychological Trauma

Interventions

Intervention group: Prolonged Exposure (PE) intervention will be provided online via a web conferencing system. Treatment is provided by a PE-certified therapist or higher in the PE treatment certific

Sponsors

Ino Keiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. meet the diagnostic criteria for PTSD in the DSM-5 2. duration of PTSD is at least 3 months 3. Age 18-65 years old 4. Patient has a family psychiatrist within easy reach 5. Patient visits his/her family psychiatrist at least once a month 6. The family psychiatrist allows the patient to receive PE 7. Family psychiatrist is available to help with usual psychiatric crises

Exclusion criteria

Exclusion criteria: 1. inexperienced operation of the web conferencing system that is deemed to interfere with the performance of treatment 2. suicide attempts or serious self-harm within the past 6 months 3. history of psychiatric hospitalization within the past 6 months (including emergency room hospitalization for high dose medication) 4. coexisting severe schizophrenia, current manic/hypomanic episodes, substance use disorder, mental retardation, or higher order dysfunction 5. ongoing litigation in which a PTSD diagnosis would be advantageous 6. other conditions deemed inappropriate by the principal investigator/principal investigator

Design outcomes

Primary

MeasureTime frame
Total PCL-5 score after treatment (TAU at 14 weeks after allocation).

Secondary

MeasureTime frame
PTSD Symptom Check List PCL-5, PTSD Diagnostic Scale PDS-IV,Childhood Trauma Questionnaire CTQ,Post Traumatic Cognitions Inventory PTCI, Dissociative Experiences Scale DES, Beck Depression Inventory-2,BDI-2, State-Trait Anxiety Inventory STAI,Social Adjustment Scale SAS-SR, Brief Pain Inventory BPI, WHO Quality of Life WHOQOL, A Revised Short Version of Working Alliance Inventory WAI-SF.

Contacts

Public ContactKeiko Ino

National Center of Neurology and Psychiatry, National Institute of Mental Health

k-ino@ncnp.go.jp+81-42-341-2711

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026