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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031948
Receipt No. R000036470
Scientific Title Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Date of disclosure of the study information 2018/04/01
Last modified on 2019/09/13

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Basic information
Public title Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Acronym Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Scientific Title Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Scientific Title:Acronym Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Region
Japan

Condition
Condition anhedonia
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This clinical trial aimed to test the efficacy of the positive valence system-focused cognitive behavior therapy with inaudible high-frequency sound against the positive-valence system focused cognitive behavior therapy with placebo sound on the anhedonic symptoms (Snaith-Hamilton Pleasure Scale) from week 1 to week 12 among the 44 patients with anhedonia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Anhedonia symptoms assessed by the Snaith-Hamilton Pleasure Scale (SHAPS) from week 1 to 12
Key secondary outcomes Anhedonia symptoms assessed by the Snaith-Hamilton Pleasure Scale-clinician administered (SHAPS-C) at week 12

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 Positive valence system-focused cognitive behavior therapy with inaudible high-frequency sounds

Positive valence system-focused cognitive behavior therapy is a psychotherapy for anhedonia. The eight weekly sessions (50 minutes for each) will be conducted during the intervention period of 11 weeks. During each treatment session, participants are exposed to inaudible high-frequency sounds.

Participants will also continue their treatment-as-usual(TAU). The most of the TAU is expected to be pharmacotherapy and clinical monitoring.
Interventions/Control_2 Positive valence system-focused cognitive behavior therapy with placebo sounds

Positive valence system-focused cognitive behavior therapy is a psychotherapy for anhedonia. The eight weekly sessions (50 minutes for each) will be conducted during the intervention period of 11 weeks. During each treatment session, participants are exposed to placebo sounds.

Participants will also continue their treatment-as-usual(TAU). The most of the TAU is expected to be pharmacotherapy and clinical monitoring.
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

Not applicable
Gender Male and Female
Key inclusion criteria (a) Anhedonic symptoms (Snaith-Hamilton Pleasure Scale score <=20)

(b) Depressive symptoms are mild or severer (GRID Hamilton depression rating scale <=8)

(c) Ages 18 years or older
Key exclusion criteria (a) No current psychotic disorders at baseline assessed by the Mini-International Neuropsychiatric Interview (MINI)

(b) No current manic episode at baseline assessed by MINI

(c) No severe substance use disorders at baseline assessed by MINI

(d) No serious suicidal ideation at baseline assessed by MINI

(e) No severe or unstable physical disorders or major cognitive deficits at baseline

(f) Other problems that can be seriously obstacle for conducting cognitive behavior therapy
Target sample size 44

Research contact person
Name of lead principal investigator
1st name Masaya, Masaru
Middle name
Last name Ito, Horikoshi
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive Behavior Therapy and Research
Zip code 187-8551
Address Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
TEL +81-42-341-2711
Email masaya-ito@umin.ac.jp

Public contact
Name of contact person
1st name Masaya
Middle name
Last name Ito
Organization National Center of Neurology and Psychiatry
Division name National Center for Cognitive-Behavior Therapy
Zip code 187-8551
Address Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
TEL +81-42-341-2711
Homepage URL
Email masaya-ito@umin.ac.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Public Health Research Foundation

IRB Contact (For public release)
Organization Institutional Review Board at National Center of Neurology and Psychiatry
Address Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
Tel +81-42-341-2711
Email ml_rinrijimu@ncnp.go.jp

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 国立精神・神経医療研究センター病院

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 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
2018 Year 03 Month 22 Day
Date of IRB
2017 Year 11 Month 13 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2020 Year 05 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 28 Day
Last modified on
2019 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036470

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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