Tokyo, Nov. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059872) titled 'A study on the efficacy of psychotherapy for complex PTSD' on Nov. 25.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - Active

Primary Sponsor: Institute - National Center of Neurology and Psychiatry

Condition: Condition - Complex posttraumatic stress disorder (Complex PTSD) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To examine the efficacy of STAIR Narrative Therapy for complex PTSD Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - STAIR Narrative Therapy with treatment-as-usual

STAIR Narrative Therapy, a psychotherapy based on the manual by Cloitre et al. (2020), consisting of 18 sessions in principle, delivered once weekly for 60 minutes each. Participants will continue their treatment-as-usual. Interventions/Control_2 - Treatment-as-usual only

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - 1) Age between 18 and 65 years at the time of consent 2) Diagnosis of complex PTSD according to ICD-11, assessed with the International Trauma Interview (ITI), with at least one identifiable traumatic memory 3) Sufficient ability to read, write, and communicate in Japanese Key exclusion criteria - 1) Current alcohol or substance use disorder not in remission for at least 3 months 2) Current comorbid schizophrenia or related disorders, severe cognitive impairment, or untreated bipolar disorder 3) Severe suicidal risk within the past 3 months (suicidal ideation or attempts requiring hospitalization or emergency care), self-harm in the past 3 months, or history of suicide attempt requiring emergency hospitalization 4) Ongoing litigation related to PTSD 5) Any other condition judged by the investigators to be inappropriate for study participation Target Size - 40

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 05 Month 28 Day Date of IRB - 2025 Year 06 Month 06 Day Anticipated trial start date - 2025 Year 11 Month 25 Day Last follow-up date - 2030 Year 03 Month 07 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068299

Disclaimer: Curated by HT Syndication.