臨床研究等提出・公開システム

Japanese version of the unified protocol for transdiagnostic treatment of emotional disorders in adolescents: A pilot study using a randomized multiple-baseline design (UP-A pilot study in Japan)

Pilot study of cognitive-behavioral therapy for Japanese adolescents with depression and/or anxiety (CBT for Japanese adolescents)

Ito Masaya

National Center of Neurology and Psychiatry

4-1-1 Ogawa-Higashi, Kodaira,Tokyo

masayait@ncnp.go.jp

Fujisato Hiroko

National Center of Neurology and Psychiatry

4-1-1 Ogawa-Higashi, Kodaira,Tokyo

+81-42-341-2711

hi.fujisato@gmail.com

Recruiting

July. 30, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1) Adolescents who meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for major depressive disorder, separation anxiety disorder, specific phobia, social anxiety disorder, panic disorder, agoraphobia, generalized anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, or adjustment disorders.
2) Adolescents who have at least moderate or worse symptoms on the Clinical Global Impressions-Severity (CGI-S) scale at the time of inclusion (CGI-S >= 4).
3) Adolescents aged between 12 and 19 years at the time of inclusion.
4) Adolescents and their parents who understand the purpose and content of this study and voluntarily provide a written consent to participate in the study.

1) Adolescents who meet the DSM-5 criteria for a hypomanic episode, manic episode, or any psychotic disorder at the time of inclusion.
2) Adolescents who have significant suicidality at the time of inclusion.
3) Adolescents who have received other structured psychotherapy at the time of inclusion or are planning to receive it during the intervention period.
4) In the case of adolescents using psychotropic medications, less than 8 weeks' use after dosage stabilization.
5) Adolescents with an intellectual disability or severe learning disorder that can interfere with their understanding of the questions or treatment materials.

Both

MDD, anxiety disorders, OCD, PTSD, adjustment disorders

UP-A is individual cognitive-behavioral therapy (CBT) for adolescents comprising eight core modules (motivation enhancement, psychoeducation about emotions, behavioral activation, awareness of body sensations, cognitive reappraisal, awareness of emotional experiences, situational emotion exposure, and relapse prevention) and an optional parent module. Approximately 60-minute treatment sessions are conducted once a week for an average of 16 sessions (12-21 sessions). These interventions are conducted based on the UP-A Therapist Guide and Workbooks.

emotional disorders

cognitive behavioral therapy, unified protocol

D003865, D001008, D001010, C562465, D000072861, D016584, D000379, D009771, D013313, D000275

D015928

Efficacy: Self-rated anxiety symptoms (Short version of the Spence Children's Anxiety Scale: Short CAS)
Feasibility: Severe adverse events

Efficacy:
1 ) Self-rated depressive symptoms (Short-form Birleson Depression Self-Rating Scale for Children: Short-form DSRS-C)
2 ) Parent-rated anxiety symptoms in adolescents (Short CAS)
3 ) Parent-rated depressive symptoms in adolescents (Short-form DSRS-C)
4 ) Self-rated emotion regulation strategies (Emotion Regulation Questionnaire for Children and Adolescents: ERQ-CA)
5 ) Parent-rated family accommodation (Family Accommodation Scale-Anxiety: FASA)
6 ) Self-rated top problems
7 ) Parent-rated top problems
8 ) Self-rated life satisfaction (Students' Life Satisfaction Scale: SLSS)
9 ) Parent-rated adolescents' life satisfaction (SLSS)

Feasibility:
1 ) Dropout proportion
2 ) Self-rated satisfaction with treatment (Client Satisfaction Questionnaire-8-Children & Youth: CSQ-8-CY)
3 ) Parent-rated satisfaction with treatment (Client Satisfaction Questionnaire-8: CSQ-8)

+81-42-341-2711

July. 05, 2021

No

none