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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000030889 |
Receipt No. | R000035227 |
Scientific Title | An open-label trial of cognitive behavioral therapy for complex posttraumatic stress disorder |
Date of disclosure of the study information | 2018/01/20 |
Last modified on | 2019/07/24 |
Basic information | ||
Public title | An open-label trial of cognitive behavioral therapy for complex posttraumatic stress disorder | |
Acronym | An open-label trial of cognitive behavioral therapy for complex PTSD | |
Scientific Title | An open-label trial of cognitive behavioral therapy for complex posttraumatic stress disorder | |
Scientific Title:Acronym | An open-label trial of cognitive behavioral therapy for complex PTSD | |
Region |
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Condition | ||
Condition | Complex Posttraumatic Stress Disorder (Complex PTSD) | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To examine the feasibility, safety, and efficacy of STAIR/NST for patients with complex PTSD |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Severity of complex PTSD assessed by PTSD & Complex PTSD Diagnostic Interview |
Key secondary outcomes | Complex PTSD severity (ICD-TQ)
Emotion regulation (DERS, NMR) Interpersonal problems (IIP) PTSD severity (PDS) |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | STAIR/NST (Skills Training in Affective and Interpersonal Regulation followed by Narrative Story Telling)
STAIR/NST is psychotherapy for complex PTSD (Cloitre et al., 2011). The sixteen weekly sessions (60 minutes for each) will be conducted. |
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Interventions/Control_2 | ||
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 |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1) Women between the ages of 18 and 65 years
2) Primary diagnosis of complex PTSD related to childhood sexual abuse and/or physical abuse before the age of 18 years 3) Native Japanese speaker |
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Key exclusion criteria | 1) Substance use disorders has not been in remission at least for 3 months
2) Comorbidity of psychotic and related disorders, significant cognitive impairment, or untreated bipolar disorder 3) Presence of acute suicidality in the previous 3 months requiring hospitalization or referral to the emergency room 4) Ongoing court litigation in relation with PTSD 5) Other relevant reason decided by the investigators |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Institute of Mental Health, National Center of Neurology and Psychiatry
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Division name | Department of Behavioral Medicine | ||||||
Zip code | 187-8553 | ||||||
Address | 4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan | ||||||
TEL | 042-341-2711 | ||||||
kim@ncnp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Institute of Mental Health, National Center of Neurology and Psychiatry | ||||||
Division name | Department of Behavioral Medicine | ||||||
Zip code | 187-8553 | ||||||
Address | 4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan | ||||||
TEL | 042-341-2711 | ||||||
Homepage URL | |||||||
m-niwa@umin.ac.jp |
Sponsor | |
Institute | National Center of Neurology and Psychiatry |
Institute | |
Department |
Funding Source | |
Organization | KAKENHI Grants-in-aid for Scientific Research |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | National Center of Neurology and Psychiatry Ethics Committee |
Address | 4-1-1, Ogawahigashi, Kodaira, Tokyo, 187-8553, Japan |
Tel | 042-341-2711 |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035227 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |