UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028577 |
|---|---|
| Receipt number | 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 13:24:42 |
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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
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
keiko-ino@umin.ac.jp
Sponsor or person
Institute
Department of Psychiatry and Cognitive Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032650
