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

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 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


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

Value
https://center6.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