UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of acceptance and commitment therapy for panic disorder patients who are resistant to cognitive behavioral therapy
Title of the study (Brief title)	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	KEIKO INO
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive Behavioral Medicine
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	KEIKO INO
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Psychiatry and Cognitive Behavioral Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 01 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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