Depressive Disorder Anxiety Disorder
Conditions
Interventions
Sponsors
Keio University, School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with DSM-V Depressive Disorder or Anxiety Disorder 2. Subjects with CGIS (Clinical Global Impression) score is 3(mildly ill), 4(Moderately ill) or 5(Markedly ill). 3. Subjects between the ages of 20 and 70 at the time of screening 4. Subjects can obtain written consent
Exclusion criteria
Exclusion criteria: 1. No alcohol or substance use disorder in 24 months prior to the screening. 2. No history or concurrent manic, psychotic episode. 3. No other primary Axis I Disorders in 6 months prior to the screening. 4. No comorbid of antisocial personality disorder. 5. No serious suicidal ideation at screening. 6. Unlikely to attend more than 4 visits during the 8-week trial phase. 7. No treatment of CBT or CBGT within the last year prior to the screening. 8. No organic brain lesions or major cognitive deficits. 9. No severe or unstable medical illness at screening. 10. Other relevant reason decided by the CogGr principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dropout rate based on the following points; 1. Voluntary discontinuation at the request of the patient 2. Discontinuation due to symptom deterioration according to clinical findings 3. Discontinuation due to absence of 3 or more sessions out of total 8 sessions The validity of the judgement of dropout will be determined by the Efficacy and Safety Evaluation Committee. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pre and post intervention assessment -Coping stress: CISS (Coping Inventory for Stressful Situation) -Depressive symptom: PHQ-9 (Patient Health Questionnaire-9) -Anxiety symptom: GAD-7 (Generalized Anxiety Disorder) -QOL: EQ5D-5L (European Quality of Life Questionnaire-5 Dimension) -Disability: SDISS (Sheehan Disability Scale) -Satisfaction: CSQ-8 (Client Satisfaction G) -Others: Questionnaire on the use of CBT skill after participating in CBGT | — |
Countries
Japan
Contacts
Public ContactMiyuki Tajima
Keio University, School of Medicine Department of Neuropsychiatry
Outcome results
None listed