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 |
Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Augmentation of positive valance system-focused cognitive behavior therapy by inaudible high-frequency sound therapy: A placebo-controlled randomized trial
Japan |
anhedonia
Psychiatry | Adult |
Others
NO
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.
Efficacy
Exploratory
Explanatory
Phase II
Anhedonia symptoms assessed by the Snaith-Hamilton Pleasure Scale (SHAPS) from week 1 to 12
Anhedonia symptoms assessed by the Snaith-Hamilton Pleasure Scale-clinician administered (SHAPS-C) at week 12
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
2
Treatment
Behavior,custom | Other |
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.
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.
18 | years-old | <= |
Not applicable |
Male and Female
(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
(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
44
1st name | Masaya, Masaru |
Middle name | |
Last name | Ito, Horikoshi |
National Center of Neurology and Psychiatry
National Center for Cognitive Behavior Therapy and Research
187-8551
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
+81-42-341-2711
masaya-ito@umin.ac.jp
1st name | Masaya |
Middle name | |
Last name | Ito |
National Center of Neurology and Psychiatry
National Center for Cognitive-Behavior Therapy
187-8551
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
+81-42-341-2711
masaya-ito@umin.ac.jp
National Center of Neurology and Psychiatry
Japan Agency for Medical Research and Development
Japanese Governmental office
Public Health Research Foundation
Institutional Review Board at National Center of Neurology and Psychiatry
Ogawahigashi 4-1-1, Kodaira, Tokyo, JAPAN
+81-42-341-2711
ml_rinrijimu@ncnp.go.jp
NO
国立精神・神経医療研究センター病院
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Completed
2018 | Year | 03 | Month | 22 | Day |
2017 | Year | 11 | Month | 13 | Day |
2018 | Year | 04 | Month | 01 | Day |
2020 | Year | 05 | Month | 10 | Day |
2018 | Year | 03 | Month | 28 | Day |
2020 | Year | 10 | Month | 01 | Day |
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 |