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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029598
Receipt No. 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

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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
Email 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
Email yk-ito@tmh.or.jp

Sponsor
Institute Tokyo Musashino Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033820

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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