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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028577
Receipt No. R000032650
Scientific Title Effectiveness of acceptance and commitment therapy for panic disorder patients who are resistant to cognitive behavioral therapy
Date of disclosure of the study information 2017/08/09
Last modified on 2017/08/08

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Basic information
Public title Effectiveness of acceptance and commitment therapy for panic disorder patients who are resistant to cognitive behavioral therapy
Acronym Effectiveness of acceptance and commitment therapy for panic disorder patients who are resistant to cognitive behavioral therapy
Scientific Title Effectiveness of acceptance and commitment therapy for panic disorder patients who are resistant to cognitive behavioral therapy
Scientific Title:Acronym Effectiveness of acceptance and commitment therapy for panic disorder patients who are resistant to cognitive behavioral therapy
Region
Japan

Condition
Condition Panic Disorder
Agraphobia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effectiveness of group Acceptance & Commitment Therapy for CBT resistant panic patient.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PDSS (Panic Disorder Severity Scale)
PDSS is evaluated at the end of therapy and 13 weeks after therapy.
Key secondary outcomes BDI-2 (Beck Depression Inventory-2)
AAQ-2(Acceptance and Action Questionnaire-2)
FFMQ(Five Facet Mind-fullness Questionnaire)
CFQ(Cognitive Fusion Questionnaire)
ASI-3(Anxiety Sensitivity Index-3)
SCL-90R(Symptom Check List 90 Revised)
SF-36(MOS 36 Item Short-Form Health Survey)
PDS(PTSD Diagnostic Scale)
PSWQ(Penn-State Worry Questionnaire)
FQ-A (Fear Questionnaire-agoraphobia subscale)
MIA(The Mobility Inventory for Agoraphobia)
ACQ(Agoraphobia Cognitive Questionnaire)
BSQ(Body Sensation Questionnaire)
AQ(Autism-Spectrum Quotient)

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
Behavior,custom
Interventions/Control_1 Group acceptance and commitment therapy:
eight to ten weekly
90min to 120min sessions

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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Female
Key inclusion criteria 1)Patient with principal diagnosis of DSM-5 Panic disorder and Agoraphobia
2)PDSS score =>8 at baseline
3)Patient who had completed group panic CBT program in Nagoya city university hospital.
4) Patinet who demnstrated less than 40% redaction of PDSS score and more than 6 of PDSS score at end of group panic CBT
Key exclusion criteria 1 Requirement for hospitalization.
2 Severe depressive symptom to interfere with the understanding of treatment material.
3 Severe suicidal ideation.
4 Psychotic symptom at baseline.
5 Manic or hypomanic episode at baseline.
6 History of schizophrenia or bipolar I disorder.
7 Mental retardation, substance abuse, mental disorders caused by general physical diseases,dementia, personality disorder.
8 Receiving other structured psychotherapy,except supportive counseling.
9 Other relevant reason decided by the investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KEIKO INO
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive Behavioral Medicine
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8271
Email keiko-ino@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name KEIKO INO
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Psychiatry and Cognitive Behavioral Medicine
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8271
Homepage URL
Email keiko-ino@umin.ac.jp

Sponsor
Institute Department of Psychiatry and Cognitive Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 08 Month 09 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
2015 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 08 Day
Last modified on
2017 Year 08 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032650

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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