A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education as a Control

A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education as a Control - A Randomized Controlled Trial of Internet based Cognitive Behavioral Therapy for Insomnia with Psychological Education

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000044016

Enrollment

405

Registered

2021-04-22

Start date

2021-06-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insonmia

Interventions

Internet-based Cognitive Behavioral Therapy program Three Good Things Exercise Sleep Hygiene Education

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Insomnia symptom(PSQI score of 6 and above, AIS score of 6 and above, and ISI score of 8 and above) Insomnia cause at least 3 nights a week and last for at least 3 months Subjects with an internet environment Subjects who can understand Japanese explanation and agree with online consent by voluntary free will

Exclusion criteria

Exclusion criteria: Moderate or severe anxiety symptom(GAD7 score of 10 and above) Moderate or severe depressive symptom(GAD7 score of 10 and above) Alcohol dependence Drug dependence Suicidal ideation(PHQ9 Question 2 of 2 and above) Cerebral organic disease such as Sleep apnea syndrome, restless legs syndrome, epilepsy, dementia, and cerebrovascular disorders Diagnosis of severe progressive physical disorders such as cancer and heart failure, and under medical treatment Subjects who are not permitted by primary doctor to participate in this research, for psychological symptoms medication including insomnia Subjects who do not go to bed twenty to two o'clock(night shift worker)

Design outcomes

Primary

Measure	Time frame
PSQI; Pittsburgh Sleep Quality Index	—

Secondary

Measure	Time frame
SOL; Sleep Onset Latency TST; Total Sleep Time SE; Sleep Efficiency AIS; Athens Insomnia Scale GAD-7; Generalized Anxiety Disorder ISI; Insomnia Severity Index PHQ-9; Patient Health Questionnaire CES-D; Center for Epidemiologic Studies Depression Scale EQ-5D-5L; EuroQOL - 5 dimensions - 5 level	—

Countries

Japan

Contacts

Public ContactDaisuke Sato

Chiba University Graduate School of Medicine Department of Cognitive Behavioral Physiology

neurophys1@ml.chiba-u.jp043-226-2027

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026