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A study on the efficacy of psychotherapy for complex PTSD

A randomized controlled trial of STAIR Narrative Therapy for complex PTSD - STAIR-NT RCT

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000059872
Enrollment
40
Registered
2025-11-25
Start date
2025-11-25
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

Complex posttraumatic stress disorder (Complex PTSD)

Interventions

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

Sponsors

National Center of Neurology and Psychiatry
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Severity of complex PTSD assessed by the International Trauma Interview (ITI) posttreatment and 3 months after treatment

Secondary

MeasureTime frame
-Severity of complex PTSD symptoms (International Trauma Questionnaire; ITQ) -Emotion regulation difficulties (Difficulties in Emotion Regulation Scale; DERS) -Interpersonal problems (Inventory of Interpersonal Problems-32; IIP-32) -Quality of life (WHO Quality of Life 26; WHO-QOL26) -Functional impairment (Work and Social Adjustment Scale; WSAS) -Severity of depressive symptoms (Beck Depression Inventory; BDI) -Severity of dissociative symptoms (Dissociative Experiences Scale; DES) -Severity of DSM-5 PTSD symptom (Posttraumatic Diagnostic Scale for DSM-5; PDS-5) -Posttraumatic cognitions (Posttraumatic Cognitions Inventory; PTCI) -Neurocognitive functioning (Repeatable Battery for the Assessment of Neuropsychological Status; RBANS) -Dropout rate and reasons for dropout -Occurrence of adverse events

Countries

Japan

Contacts

Public ContactMadoka Niwa

National Institute of Mental Health, National Center of Neurology and Psychiatry Department of Behavioral Medicine

cptsd.scale@ncnp.go.jp+81-42-341-2711

Outcome results

None listed

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