UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013693
Receipt number R000015984
Scientific Title Adding smartphone cognitive-behavior therapy to pharmacotherapy for major depression: A randomized control trial
Date of disclosure of the study information 2014/06/01
Last modified on 2017/12/19 12:35:20

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Basic information

Public title

Adding smartphone cognitive-behavior therapy to pharmacotherapy for major depression: A randomized control trial

Acronym

FLATT1

Scientific Title

Adding smartphone cognitive-behavior therapy to pharmacotherapy for major depression: A randomized control trial

Scientific Title:Acronym

FLATT1

Region

Japan


Condition

Condition

Major depressive disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the value of adding smartphone cognitive-behavior therapy to pharmacotherapy
for major depression

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Slope of Patient Health Questionnaire-9 (PHQ-9) scores at 0, 1, 5 and 9 weeks

Key secondary outcomes

Slope of Beck Depression Inventory-II (BDI-II) scores at 0, 1, 5 and 9 weeks,
Response rate at 9 weeks (defined as 4 or less on PHQ-9)
Treatment satisfaction at 9 weeks
Continuation of antidepressant pharmacotherapy through 9 weeks
Slope of Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER) scores at 0, 1, 5 and 9 weeks


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Other

Interventions/Control_1

smartphone cognitive-behavior therapy in addition to switch to escitalopram 5-10 mg/day or sertraline 25-100 mg/day

Interventions/Control_2

Switch to escitalopram 5-10 mg/day or sertraline 25-100 mg/day

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

25 years-old <=

Age-upper limit

59 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Age between 25 and 59, of both sexes
2) Primary diagnosis is major depressive disorder (DSM-5)
3) Pharmacotherapy-resistant, as confirmed by no to partial response to one or more antidepressants at adequate dose for four or more weeks and scoring 10 or more on BDI-II
4) Antidepressant as monotherapy with no concomitant antipsychotic or mood stabilizer
5) Indication for smartphone CBT according to treating physician
6) Adequate knowledge of smartphone
7) Outpatient at enrollment

Key exclusion criteria

1) Treatment with monoamine oxidase inhibitors, electroconvulsive therapy , repetitive transcranial magnetic stimulation, escitalopram/sertraline or individual face-to-face cognitive-behavior or interpersonal therapy during the index episode
2) Psychiatric omorbidities
2-1) Lifetime diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder
2-2) Current diagnosis of neurocognitive disorder, eating disorder, substance dependence or borderline personality disorder
3) Imminent risk of suicide
4) Physical comorbidities that interfere with escitalopram treatment
4-1) prolonged QTc (>450 ms for men, and >470 for women)
4-2) co-administration of drugs known to cause QTc prolongation as judged by treating physician
5) Pregnant or breast-feeding women
6) Current participation in another clinical intervention research

Target sample size

164


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiaki A. Furukawa

Organization

Kyoto University Graduate School of Medicine / School of Public Health

Division name

Dept of Health Promotion and Human Behavior

Zip code


Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

075-753-9491

Email

furukawa@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiaki A. Furukawa

Organization

Kyoto University Graduate School of Medicine / School of Public Health

Division name

Dept of Health Promotion and Human Behavior

Zip code


Address

Yoshida Konoe-cho, Sakyo-ku, Kyoto

TEL

075-753-9491

Homepage URL


Email

furukawa@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Japan Foundation of Neuroscience and Mental Health

Institute

Department

Personal name



Funding Source

Organization

Japan Foundation of Neuroscience and Mental Health

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


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

名古屋市立大学病院(愛知県)、早稲田クリニック(愛知県)、高知大学医学部附属病院(高知県)、愛宕病院(高知県)、北海道大学病院(北海道)、新さっぽろメンタルクリニック(北海道)、北大通こころのクリニック(北海道)、東邦大学大森病院(東京都)、東邦大学大橋病院(東京都)、銀座泰明クリニック(東京都)、あらたまこころのクリニック(愛知県)、志岐クリニック(愛知県)、鳴海ひまわりクリニック(愛知県)、船山メンタルクリニック(愛知県)、広島大学病院(広島県)、まんたに心療内科(広島県)、草津病院(広島県)、呉医療センター(広島県)


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 01 Day


Related information

URL releasing protocol

http://www.ncbi.nlm.nih.gov/pubmed/26149441

Publication of results

Published


Result

URL related to results and publications

http://www.jmir.org/2017/11/e373/

Number of participants that the trial has enrolled


Results

Please see:
Mantani A, Kato T, Furukawa TA, Horikoshi M, Imai H, Hiroe T, Chino B, Funayama T, Yonemoto N, Zhou Q & Kawanishi N (2017) Smartphone Cognitive Behavioral Therapy as an Adjunct to Pharmacotherapy for Refractory Depression: Randomized Controlled Trial. Journal of Medical Internet Research, 19, e373.

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

Main results already published

Date of protocol fixation

2014 Year 04 Month 04 Day

Date of IRB


Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date

2016 Year 10 Month 31 Day

Date of closure to data entry

2016 Year 10 Month 31 Day

Date trial data considered complete

2016 Year 12 Month 31 Day

Date analysis concluded

2017 Year 06 Month 30 Day


Other

Other related information

The following secondary papers have been published:
Furukawa TA, Horikoshi M, Fujita H, Tsujino N, Jinnin R, Kako Y, Ogawa S, Sato H, Kitagawa N, Shinagawa Y, Ikeda Y, Imai H, Tajika A, Ogawa Y, Akechi T, Yamada M, Shimodera S, Watanabe N, Inagaki M & Hasegawa A (in press) How do patients with major depression use and benefit from smartphone CBT? Content analyses of completed cognitive and behavioral skills exercises with Kokoro-app. JMIR Mental Health.


Management information

Registered date

2014 Year 04 Month 11 Day

Last modified on

2017 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015984


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name