vCBT-GAD RCT

JRCT ID: jRCT1032240185

Registered date:26/06/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: generalized anxiety disorder
• Date of first enrollment: 26/06/2024
• Target sample size: 24
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Change in HAM-A from week 0 (baseline) at week 16

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Shimizu Eiji
• Secondary Sponsor: JSPS KAKENHI