Anxiety Disorders Depressive Disorders
Conditions
Interventions
Unified Protocol with Treatment As Usual Unified Protocol is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more a
Sponsors
National Center of Neurology and Psychiatry, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) DSM-IV or DSM-5 diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID or M.I.N.I.. b) Depressive and anxiety symptoms is mild or more severe (GRID-HAMD >= 8). c) Ages 20 years or older, and 65 years or younger at screening. d) Subjects who give full consent in the participation of the study.
Exclusion criteria
Exclusion criteria: a) No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID or M.I.N.I.. b) No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID or M.I.N.I.. c) No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.) d) No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline. e) Evidence of unable to participate half or more of the intervention phase. f) No structured psychotherapy during at baseline. g) Other relevant reason decided by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GRID-Hamilton Depression Rating Scale-17 (GRID-HAMD) [Time Frame: 21 weeks] | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Therapeutic Mechanisms and Processes (Patient-Reported Questionnaires for Therapeutic Mechanisms) Neuroticism (EPQR-S) [Time Frame: 21 weeks] Anxiety Sensitivity (ASI) [ Time Frame: 21 weeks] Emotion Regulation Skills (ERSQ) [Time Frame: 21 weeks] Emotional Exposure Scale (EES) [Time Frame: 21 weeks] Therapeutic Principles of the Unified Protocol (TRUP) [Time Frame: 21 weeks] (Process Measures) Credibility/Expectancy Questionnaire (CEQ) : Rated by both therapist and patient [Time Frame: 21 weeks] Session Rating Scale (SRS) : Rated by both therapist and patient [Time Frame: 21 weeks] Homework Compliance Scale (HCS) : Rated by therapist [Time Frame: 21 weeks] Therapist Adherence Scale (TAS) : Rated by supervisors and independent raters [Time Frame: 21 weeks] Neuroimaging Data 3-Tesla MRI: Resting-state fMRI and T1-weighted 3D structural images [Time Frame: 21 weeks] | — |
Countries
Japan
Contacts
Public ContactMasaya Ito
National Center of Neurology and Psychiatry National Center of Cognitive-Behavior Therapy and Research
Outcome results
None listed