UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029598 |
|---|---|
| Receipt number | R000033820 |
| Scientific Title | Group Acceptance and Commitment Therapy for Japanese patients with Depressive or Anxiety symptoms: A Pilot Study |
| Date of disclosure of the study information | 2017/10/18 |
| Last modified on | 2018/05/29 21:29:31 |
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Basic information
Public title
Group Acceptance and Commitment Therapy for Japanese patients with Depressive or Anxiety symptoms: A Pilot Study
Acronym
A pilot study of group ACT
Scientific Title
Group Acceptance and Commitment Therapy for Japanese patients with Depressive or Anxiety symptoms: A Pilot Study
Scientific Title:Acronym
A pilot study of group ACT
Region
| Japan |
Condition
Condition
Subjective depressive and/or anxiety symptoms
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility and the effectiveness of group ACT for depressive and/or anxiety symptoms.
Basic objectives2
Others
Basic objectives -Others
We develop the transdiagnostic Acceptance and Commitment group therapy and expand the program based upon the feedbacks acquired from the treatment provider team(e.g., Dr,Ns,CP,OT,PSW).
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Beck Depression Inventory-2(pre-treatment, 8 week,12 week and 20 week.)
Key secondary outcomes
(1) Diagnoses assessed by the M.I.N.I.
(2) State-Trait Anxiety Inventory
(3) 36-item Short Form Health Survey
(4) Mindful Attention Awareness Scale
(5) Acceptance and Action Questionnaire-2
(6) Satisfaction
(7) Dropout rate
(8) Adverse evnents
(9) The usuability of the program evaluated by CP,OT,PSW
(1) to (4) are evaluated at pre-treatment,8week and 12week. (5) is conducted at pre-treatment,3week,5week,7week,8week
and 12week. (6) is conducted at every session.
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 | Maneuver |
Interventions/Control_1
8 session of 100 minutes group ACT.
Follow up sessions are held at 6 week and 10 week post to the treatment period.
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Psychiatric outpatients with subjective depressive and/or anxiety symptoms
(2) Aged 18 years or order, and 70 years or younger at screening
(3) Subjects who give full consent in the participation of the study
Key exclusion criteria
(1) Manic state or psychotic symptoms
(2) Diagnosis of schizophrenia
(3) Diagnosis of dementia
(4) Currently receiving any other structured psychotherapy during the intervention
(5) Other relevant reason decided by the investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Ito |
Organization
Tokyo Musashino Hospital
Division name
Department of Psychiatry
Zip code
Address
4-11-11, Komone, Itabashi-ku, Tokyo, Japan
TEL
03-5986-3111
yk-ito@tmh.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuka Ito |
Organization
Tokyo Musashino Hospital
Division name
Department of Psychiatry
Zip code
Address
4-11-11, Komone, Itabashi-ku, Tokyo, Japan
TEL
03-5986-3111
Homepage URL
yk-ito@tmh.or.jp
Sponsor or person
Institute
Tokyo Musashino Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
精神医学研究所附属 東京武蔵野病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 18 | 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
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2018 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033820
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| Registered date | File name |
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