UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031948
Receipt number 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 2020/10/01 09:48:19

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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 or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



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

Completed

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

2020 Year 10 Month 01 Day



Link to view the page

Value
https://center6.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