UMIN-CTR Clinical Trial

Public title

Feasibility trial of mindfulness-based cognitive therapy (MBCT) follow-up programs for anxiety disorders

Acronym

Feasibility trial of MBCT follow-up programs for anxiety disorders

Scientific Title

Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy (MBCT) follow-up engagement programs for anxiety disorders : a randomised controlled feasibility trial

Scientific Title:Acronym

Effectiveness and cost-effectiveness of MBCT follow-up engagement programs for anxiety disorders : a randomised controlled feasibility trial

Region

Japan

Condition

Anxiety disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the feasibility of follow-up engagement program of MBCT for the patients with anxiety disorders (panic disorder, agoraphobia, and social anxiety disorder). To investigate whether this program is effective and cost effective compared to the control group or not.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

1) enrollment rate, 2) dropout rate, 3)retention rate, 4) mean and standardized deviation of the clinical parameters (STAI) at 5, 8, 12months

Key secondary outcomes

mean and standardized deviation of the following clinical parameters at 5, 8, 12months: Panic disorder severity scale, Mobility inventory, LSAS-J, SF-36, SPANE, RSES, FFMQ, CD-RISC, SCS, QIDS, GAD7, PSS, HPQ, SWLS, FS, MAIA, EQ-5D, HAM-A, interoception, healthcare service usage, medication adherence, adherence to home work etc. Cost effectiveness will be assessed by Incremental Cost Effectiveness Ratio using quality adjusted life years as a clinical parameter.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

8 weekly sessions of MBCT + 10 monthly follow-up engagement program

Interventions/Control_2

8 weekly sessions of MBCT only

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

/Diagnosed as panic disorder, agoraphobia, or social anxiety disorder, based on SCID
/ No improvement after 4 week's TAU
/Ability to consent in writing

Key exclusion criteria

/Past history of substance related disorders
/Alcohol dependence
/Drug dependence
/Anti social personality disorder
/Severe suicidal ideation or self-harm behaviour
/Difficult to follow up for 12 months after start of intervention
/Dissent to the possibility of being allocated to the control group
/Organic brain disorders
/Other severe general medical conditions

Target sample size

50

Name of lead principal investigator

1st name	mitsuhiro
Middle name
Last name	sado

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-(0)3-5363-3971

Email

mitsusado@keio.jp

Name of contact person

1st name	mitsuhiro
Middle name
Last name	sado

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

168-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-(0)3-5363-3971

Homepage URL

Email

mitsusado@keio.jp

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

Tel

+81-(0)3-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

11

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

43

Results

Results date posted

Results Delayed

Delay expected

Results Delay Reason

Due to the delay in analysis.

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2019

Year

11

Month

19

Day

Date of IRB

2019

Year

11

Month

18

Day

Anticipated trial start date

2019

Year

11

Month

19

Day

Last follow-up date

2022

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

11

Month

19

Day

Last modified on

2023

Year

06

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044009