UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059872 |
|---|---|
| Receipt number | R000068299 |
| Scientific Title | A randomized controlled trial of STAIR Narrative Therapy for complex PTSD |
| Date of disclosure of the study information | 2025/11/25 |
| Last modified on | 2025/11/25 11:58:35 |
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Basic information
Public title
A study on the efficacy of psychotherapy for complex PTSD
Acronym
STAIR-NT RCT
Scientific Title
A randomized controlled trial of STAIR Narrative Therapy for complex PTSD
Scientific Title:Acronym
STAIR-NT RCT
Region
| Japan |
Condition
Condition
Complex posttraumatic stress disorder (Complex PTSD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of STAIR Narrative Therapy for complex PTSD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Severity of complex PTSD assessed by the International Trauma Interview (ITI) posttreatment and 3 months after treatment
Key secondary outcomes
-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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Madoka |
| Middle name | |
| Last name | Niwa |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Behavioral Medicine
Zip code
187-8553
Address
4-1-I, Ogawahigashi, Kodaira, Tokyo, Japan
TEL
+81-42-341-2711
cptsd.scale@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Niwa |
Organization
National Institute of Mental Health, National Center of Neurology and Psychiatry
Division name
Department of Behavioral Medicine
Zip code
187-8553
Address
4-1-I, Ogawahigashi, Kodaira, Tokyo, Japan
TEL
+81-42-341-2711
Homepage URL
cptsd.scale@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Okamoto Mental Health Foundation, Japan
IRB Contact (For public release)
Organization
Institutional Review Board at National Center of Neurology and Psychiatry
Address
4-1-I, Ogawahigashi, Kodaira, Tokyo, Japan
Tel
+81-42-341-2711
ml_rinrijimu@ncnp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立精神・神経医療研究センター病院（東京都）
メンタルエイドクリニック（東京都）
かとうメンタルクリニック（北海道）
ほりメンタルクリニック（福島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068299
