Tokyo, April 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061374) titled 'Feasibility Study of a Self-Help Psychoeducational Program for Working Adults with ADHD Traits' on April 25.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Chiba University
Condition:
Condition - Attention-deficit/hyperactivity traits in adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to examine the feasibility and acceptability of a CBT-based self-help psychoeducational smartphone application for working adults with attention-deficit/hyperactivity traits, and to evaluate changes in attention-deficit/hyperactivity symptoms before and after app use.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants will use a CBT-based self-help psychoeducational smartphone application for 4 weeks.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - 1.Male or female adults aged 18 to 39 years.
2.Individuals working at least 20 hours per week.
3.Individuals with attention-deficit/hyperactivity traits who experience difficulties in daily life (ASRS Part A score of 4 items or more).
4.Individuals with access to the internet (via a computer, smartphone, or tablet).
5.Native Japanese speakers who can understand explanations in Japanese and provide informed consent online voluntarily.
Key exclusion criteria - 1.Individuals diagnosed with schizophrenia, delusional disorder or other psychotic disorders, dementia, intellectual disability, severe depression (PHQ-9 > 19), bipolar disorder, or substance use disorder.
2.Individuals with a high risk of suicide (PHQ-9 item 9 > 1).
3.Individuals currently receiving structured psychotherapy or planning to receive it during the study period.
4.Individuals who have received cognitive behavioral therapy within the past 6 months.
5.Individuals deemed inappropriate for participation by the investigators.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 12 Day
Date of IRB - 2025 Year 11 Month 12 Day
Anticipated trial start date - 2026 Year 04 Month 15 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070078
Disclaimer: Curated by HT Syndication.