UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021670 |
|---|---|
| Receipt number | R000024285 |
| Scientific Title | A single-center, assessor-blind, randomized, 16-week intervention, parallel-group, superiority study to compare the efficacy of combined out-patient cognitive-processing therapy and treatment-as-usual versus treatment-as-usual only in the reduction of post-traumatic stress symptoms of patients with posttraumatic stress disorders. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2023/04/04 17:13:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A single-center, assessor-blind, randomized, 16-week intervention, parallel-group, superiority study to compare the efficacy of combined out-patient cognitive-processing therapy and treatment-as-usual versus treatment-as-usual only in the reduction of post-traumatic stress symptoms of patients with posttraumatic stress disorders.
Acronym
Randomized Controlled Trial of Cognitive Processing Therapy for Posttraumatic stress disorder:Safety, Power, Intimacy, Esteem, Trust to PTSD patient (SPINET)
Scientific Title
A single-center, assessor-blind, randomized, 16-week intervention, parallel-group, superiority study to compare the efficacy of combined out-patient cognitive-processing therapy and treatment-as-usual versus treatment-as-usual only in the reduction of post-traumatic stress symptoms of patients with posttraumatic stress disorders.
Scientific Title:Acronym
Randomized Controlled Trial of Cognitive Processing Therapy for Posttraumatic stress disorder:Safety, Power, Intimacy, Esteem, Trust to PTSD patient (SPINET)
Region
| Japan |
Condition
Condition
Post-traumatic Stress Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial aimed to test the efficacy of the combined out-patient cognitive processing therapy and treatment-as-usual against the treatment-as-usual only on the post-traumatic stress symptoms (CAPS-5) at 17-week among the patients diagnosed as post-traumatic stress disorder
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Post-traumatic stress symptoms assessed by Clinician Administered PTSD scale for DSM-5 diagnoses at 17-week
Key secondary outcomes
Post-traumatic stress symptoms assessed by PTSD Check List for DSM-5 at 17-week
Responder status at 17-week
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 not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Cognitive processing therapy with treatment-as-usual
Cognitive processing therapy is a psychotherapy for PTSD(Resick et al., 2014). The twelve to sixteen weekly sessions (50 minutes for each) will be conducted during the intervention period of 16 weeks.
Participants will continue their treatment-as-usual(TAU). The most of the TAU is expected to be pharmacotherapy and clinical monitoring.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(a) DSM-5 diagnosis of Post-traumatic Stress Disorder assessed by CAPS-5
(b) Ages 18 years or older, and 70 years or younger at baseline.
(c) Subjects who give full consent in the participation of the study.
Key exclusion criteria
(a) No severe substance use disorders at baseline as assessed by the Mini-International Neuropsychiatric Interview (MINI)
(b) No current manic episode or current psychotic disorders at baseline assessed by MINI
(c) No serious suicidal ideation at baseline assessed by MINI
(d) No severe or unstable physical disorders or major cognitive deficits at baseline.
(e) No structured psychotherapy at baseline.
(f) Other relevant reason decided by the investigators.
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Masaya, Masaru |
| Middle name | |
| Last name | Ito, Horikoshi |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive-Behavior Therapy
Zip code
187-8551
Address
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
TEL
+82-42-341-2711
masaya-ito@umin.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Ito |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive-Behavior Therapy
Zip code
187-8551
Address
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
TEL
+82-42-341-2711
Homepage URL
masaya-ito@umin.ac.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
KAKENHI Grant-in-Aid (A)
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
Institutional Review Board at National Center of Neurology and Psychiatry
Address
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
Tel
042-341-2711
rinri-jimu@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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://bmjopen.bmj.com/content/7/6/e014292
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 29 | Day |
Last modified on
| 2023 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024285
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
