generalized anxiety disorder generalized anxiety disorder
Conditions
Interventions
The group receiving an 16-week course of videoconference-based cognitive behavioral therapy, consisting of weekly 50-minute sessions, with treatment as usual and the treatment as usual group.
Cognitive Behavioral Therapy
Sponsors
Shimizu Eiji
JSPS KAKENHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects in this study were those who met all of the following criteria: 1) Meets the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) for generalized anxiety disorder. 2) Between the ages of 18 and 65 at the time of consent. 3) Voluntary, written consent is obtained from the participant after sufficient explanation and upon sufficient understanding at the clinical assessment. 4) Pharmacotherapy (e.g., psychotropic medication) for generalized anxiety disorder is permissible, so long as there are no plans to begin new pharmacotherapy or change existing pharmacotherapy during the trial period. 5) Able to understand explanation of cognitive behavioral therapy, and mentally and physically able to continuously receive training for at least 16 weeks.
Exclusion criteria
Exclusion criteria: Those with severe psychiatric symptoms caused by organic brain syndromes including dementia, psychosis, bipolar disorders, or those with drug abuse or dependence. Those at imminent risk of suicide. Those with a serious, progressive physical illness including cancer, cardiac disease and stroke. Those with mental developmental delays and borderline intellectual function. Those who have received cognitive behavioral therapy within the last 6 months. Any other person who the physicians or therapists deem unable to safely participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HAM-A from week 0 (baseline) at week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in HAM-A from week 0 (baseline) at week 8 2. Changes in the following items (PSWQ, GAD7, PHQ9, STAI, EQ-5D-5L, BDI-II) from week 0 (baseline) at week 8 and week 16 3. Names and daily doses of psychotropic drugs 4. Adverse events | — |
Contacts
Public ContactAkari Matsuzawa
Chiba University
Outcome results
None listed