This study is to examine the superiority of the combined treatments of transdiagnostic cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms among depressive and anxiety disorders.
Participants with depressive or anxiety disorders will be randomized to either Unified Protocol with Treatment-As-Usual or Wail-list with Treatment-As-Usual. Intervention period will be 20-week and the follow-up period will be 43 week from registration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
Unified Protocol(UP) is a transdiagnostic cognitive-behavioral therapy for depressive and anxiety disorders, which is developed by Dr. Barlow and his colleagues at Boston university. UP is weekly, face to face, individual psychotherapy consisting of 9 to 20 sessions. Average session number is 16 sessions. Contents of the treatment includes motivational enhancement, psychoeducation of treatment rationale and emotion, emotion awareness training, cognitive reappraisal, avoidance and emotion driven behaviors, interoceptive exposure and emotion exposure.
Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan
GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD)
Time frame: 21 weeks
Hamilton Anxiety Rating Scale 14 item(HAM-A)
Time frame: 21 weeks
Clinical Global Impression- Severity(CGI-S)
Time frame: 21 weeks
Clinical Global Impression-Improvement(CGI-I)
Time frame: 21 weeks
Responder Status assessed by GRID-HAMD
Reduction in GRID-HAMD score of at least 50% compared with baseline
Time frame: 21 weeks
Remission of symptoms assessed by GRID-HAMD
GRID-HAMD score of less than 8
Time frame: 21 weeks
Psychiatric diagnosis assessed by Structured Clinical Interview for the DSM(SCID)
Time frame: 21 weeks
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