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
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
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
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
