Tokyo, Oct. 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059428) titled 'One-Year Follow-Up Study on the Prognosis of Adult Patients with Generalized Anxiety Disorder' on Oct. 23.
Study Type:
Observational
Primary Sponsor:
Institute - Chiba University
Condition:
Condition - Generalized Anxiety Disorder
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Patients who participated in the randomized controlled trial "Online Cognitive Behavioral Therapy in Addition to Treatment-as-Usual versus Treatment-as-Usual Alone for Adult Patients with Generalized Anxiety Disorder (G2023010)" will be followed up within the scope of routine clinical practice, and changes in clinical data will be observed. Since the natural course of one-year changes following online cognitive behavioral therapy for generalized anxiety disorder has not yet been clarified, it is of clinical significance to conduct follow-up and observational assessments.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Patients who meet all of the following criteria will be included:
The primary diagnosis meets the diagnostic criteria for generalized anxiety disorder (DSM-5).
Age between 18 and 65 years at the time of obtaining informed consent.
Written informed consent is obtained voluntarily from the patient after receiving a sufficient explanation of the study and demonstrating adequate understanding.
Usual treatment (regular consultations with a primary physician are mandatory, and the presence or absence of pharmacotherapy for generalized anxiety disorder at the time of entry is not restricted) is being provided, and no new initiation or additional changes in pharmacotherapy for generalized anxiety disorder are planned during the study period.
Pharmacotherapy for generalized anxiety disorder refers to psychotropic medications such as antidepressants, anxiolytics, or hypnotics, regardless of indication.
The patient is able to understand cognitive behavioral therapy and is in a mental and physical condition that allows for continuous practice for at least 16 weeks.
Key exclusion criteria - The following individuals will be excluded:
Those with comorbid schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, substance-related and addictive disorders, neurocognitive disorders, or neurodevelopmental disorders.
Those at imminent risk of suicide.
Those with serious physical illnesses such as cancer, heart disease, or stroke.
Those with intellectual disability (estimated IQ < 80 based on the JART-25: Japanese Adult Reading Test-25 or similar measures).
Those who have received cognitive behavioral therapy within the past six months.
Any other individuals deemed unsuitable for safe participation in this study by the principal investigator or study therapists.
Target Size - 24
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 07 Month 28 Day
Date of IRB - 2025 Year 07 Month 28 Day
Anticipated trial start date - 2025 Year 07 Month 28 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067810
Disclaimer: Curated by HT Syndication.
