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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013693
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Institute Japan Foundation of Neuroscience and Mental Health
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015984


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