Psychological Intervention Program on Insomnia Symptoms

A Randomized Controlled Trial of Internet-Based Psychosocial Intervention for Safety Behaviors on Insomnia Symptoms - Prevention of Safety Behaviors on Insomnia Symptoms (PSBIS)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000044770

Enrollment

Registered

2021-07-06

Start date

2021-07-07

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

Insomnia Symptoms

Interventions

FSET for sleep (False Safety Aid Elimination Therapy for Sleep Treatment) PHET (Physical Health Education Treatment)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Insomnia symptoms (ISI score of 8 and above). 2) Interest in improving their own sleep and willingness to work on tasks and to record their sleep. 3) Subjects with access to a computer to view online websites. 4) Subjects who can understand Japanese explanation and agree with online consent by voluntary free will.

Exclusion criteria

Exclusion criteria: 1) Presence of treatment and hospital visits for sleep disorders or mental illness. 2) Subjects engaged in shift work, including late night. 3) Suicidal ideation (PHQ9 Question 2 of 2 and above).

Design outcomes

Primary

Measure	Time frame
ISI (Insomnia Severity Index)	—

Secondary

Measure	Time frame
SOL (Sleep Onset Latency) WASO (Wake after sleep onset) NOA (Number of awaking) TST (Total Sleep Time) SE (Sleep Efficiency) PHQ-9 (Patient Health Questionnaire) GAD-7 (Generalized Anxiety Disorder)	—

Countries

Japan

Contacts

Public ContactAyaka Ubara

Doshisha Unibersity Graduate School of Psychology

cykc1005@mail2.doshisha.ac.jp0774-65-8276

Outcome results

None listed

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