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

JRCT ID: jRCT1030240132

Registered date:03/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: PTSD, Post Traumatic Stress Disorder
• Date of first enrollment: 03/06/2024
• Target sample size: 24
• Study type: Interventional

Intervention(s)

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 certification system, following the treatment manual by Edna Foa et al, the originators of PE.Each session will last 90 minutes, once a week, for 10-16 sessions. Treatment is initiated after documenting medical coordination with the family psychiatrist and obtaining approval to cooperate in responding to the crisis.
TAU group:General psychiatric care (medication and psychoeducation, lifestyle guidance, etc.) at the family physchiatrist at least once a month.

Outcome(s)

• Primary Outcome: Total PCL-5 score after treatment (TAU at 12 weeks after allocation).
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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 doctor 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

Exclude 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

Related Information

• Primary Sponsor: Ino Keiko
• Source(s) of Monetary Support: Japan Society for the Promotion of Science (JSPS),Japan Agency of Medical Research and Development