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Efficacy of Reasonable Access to Brief Behavioral Insomnia Treatment

Brief cognitive behavioral therapy for insomnia provided by healthcare workers: A protocol of a multi-center randomized controlled trial - Effectiveness of Brief Cognitive Behavioral Therapy for Insomnia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000052911
Enrollment
76
Registered
2024-01-10
Start date
2024-01-15
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

chronic insomnia

Interventions

Intervention is a brief cognitive behavioral therapy with 2-week intervals, a total of 3 interviews, each lasting about 15 minutes. The control group will receive the usual treatment and sleep hygien

Sponsors

University of Toyama
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Meets the diagnostic criteria for chronic insomnia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5). 2.Score of 8 or more on the Insomnia Severity Index (ISI). 3.Is being treated with sleeping medication or is not taking sleeping medication at his/her request. 4.Other psychotropic medications have been stable for the past 3 months and are not expected to change until 12 weeks after the start of the study (note: sleeping medications can be reduced or discontinued).

Exclusion criteria

Exclusion criteria: 1.The primary illness or complication is a physical illness and the patient is in severe physical distress such as pain, dyspnea, etc. 2.Patients with psychiatric disorders other than depression and anxiety such as schizophrenia, bipolar disorder, dementia, substance dependence, personality disorder, eating disorder, and intellectual developmental disorder (if diagnosed as moderate or higher). 2) Patients with depression and anxiety and with severe symptoms such as suicidal ideation. 3.The patient is engaged in shift work involving night shifts (shift workers). 4.Has serious problems in his/her life (e.g., harassment) that prevent him/her from devoting himself/herself to treatment. 5.Has difficulty reading and writing Japanese. 6.Other problems that make it difficult for the attending physician to participate in this study.

Design outcomes

Primary

MeasureTime frame
ISI(8 weeks post-intervention)

Secondary

MeasureTime frame
ISI(12 weeks post-intervention) EQ-5D-5L/PAQ9/GAD7/ST/WACO/TST/SE(8 weeks and 12 weeks post-intervention)

Countries

Japan

Contacts

Public ContactMakie Nagai

University of Toyama Department of Public Health, Faculty of Medicine

m-nagai@amall.co.jp080-8850-0489

Outcome results

None listed

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