Unique ID issued by UMIN | UMIN000023632 |
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Receipt number | R000027209 |
Scientific Title | Feasibility study of group unified protocol psychotherapy for patients with depressive and anxiety disorders |
Date of disclosure of the study information | 2016/08/17 |
Last modified on | 2019/02/21 17:23:25 |
Feasibility study of group unified protocol psychotherapy for patients with depressive and anxiety disorders
Pilot study of group unified protocol for anxiety and depression (GUPPY Study)
Feasibility study of group unified protocol psychotherapy for patients with depressive and anxiety disorders
Pilot study of group unified protocol for anxiety and depression (GUPPY Study)
Japan |
Unipolar mood disorders, Anxiety disorders
Psychiatry |
Others
NO
To examine the feasibility of the group format of the unified protocol for adult patients with unipolar mood and/or anxiety disorders.
Safety,Efficacy
Exploratory
Phase I,II
1. The Clinical Global Impressions Scale-Severity(CGI-S)
2. Objective severity of depressive symptoms(GRID-HAMD)
1. The Clinical Global Impressions Scale- Improvement(CGI-I)
2. Subjective severity of Anxiety and impairment(OASIS)
3. Subjective severity of Depression and impairment(ODSIS)
4. Quality of life(EQ-5D-5L)
5. Function(SDISS/GAF)
6. Emotion Regulation(ERSQ)
7. Neuroticism(EPQR-S)
8. Subjective symptoms for primary diagnosis
9. Drop Out rate
10. Adverse Event
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Behavior,custom |
Group cognitive behavioral therapy (Unified Protocol)
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1. Subjects with current DSM-IV Panic disorder with/without Agoraphobia, Agoraphobia without history of Panic Disorder, Specific Phobia, Social Phobia (Social Anxiety Disorder), Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, Generalized Anxiety Disorder, Major Depressive Disorder, Dysthymic disorder
2. The Clinical Global Impressions Scale-Severity of illness >= 4
3. Age 20 years or older, and 65 years or younger at screening
4. Subjects who give full consent in the participation of the study
1. No alcohol or substance use disorder in a year prior to the baseline
2. No manic episode or psychotic disorders at baseline
3. No serious suicidal ideation at baseline (GRID-HAMD Item 3 symptom intensity is less than moderate)
4. Evidence of unable to participate half or more of the intervention phase
5. No structured psychotherapy (except supportive therapy) during the intervention
6. No major cognitive deficits or No life-threatening, severe or unstable physical disorders at baseline
7. Other relevant reason decided by the investigators
24
1st name | |
Middle name | |
Last name | Masaru Horikoshi Ph.D. |
National Center of Neurology and Psychiatry
National Center for Cognitive Behavior Therapy and Research
Ogawahigashi4-1-1, Kodaira-shi, Tokyo, Japan
042-341-2711
mhorikoshi@ncnp.go.jp
1st name | |
Middle name | |
Last name | Noriko Kato |
National Center of Neurology and Psychiatry
National Center for Cognitive Behavior Therapy and Research
Ogawahigashi4-1-1, Kodaira-shi, Tokyo, Japan
042-341-2711
norikokato@ncnp.go.jp
National Center of Neurology and Psychiatry
Japan Society for the Promotion of Science
Japanese Governmental office
Keio University School of Medicine
Nishimura clinic
NO
国立精神・神経医療研究センター(東京都)
慶應義塾大学医学部(東京都)
にしむらクリニック(東京都)
2016 | Year | 08 | Month | 17 | Day |
Unpublished
Completed
2016 | Year | 06 | Month | 06 | Day |
2016 | Year | 08 | Month | 24 | Day |
2018 | Year | 12 | Month | 01 | Day |
2019 | Year | 01 | Month | 10 | Day |
2016 | Year | 08 | Month | 15 | Day |
2019 | Year | 02 | Month | 21 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027209
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