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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021670
Receipt No. 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 2019/07/09

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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
Email 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
Email masaya-ito@umin.ac.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

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
Email 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
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 Open public recruiting
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
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 29 Day
Last modified on
2019 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.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


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