Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances

NCT07603687 | Not Yet Recruiting

• 1 other identifier: 202603048RINE
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to develop a in person nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention integrated with a chatbot and evaluate its effects on sleep disturbance, anxiety, depression, and fatigue among community-dwelling adults, as well as user acceptance and satisfaction with the chatbot-assisted intervention. Participants who meet the inclusion criteria will be randomly assigned to either an intervention group receiving BBT-I combined with a chatbot or a self-monitoring control group.

Conditions

Sleep Disturbance; Insomnia

Keywords

sleep disturbance; Brief Behavioral Treatment for Insomnia

Outcome Measures

Primary Outcomes (5)

• Sleep and health diary

  Daily self-recording of sleep behaviors during the intervention. Such as time in/out of bed, napping, and subjective sleep quality along with lifestyle factors like screen time, diet, and exercise, helps researchers understand subjects' actual sleep patterns and health behaviors.

  Daily self-recording during one month intervention period

• Insomnia Severity Index

  The Insomnia Severity Scale (ISI) is a 7-item self-report scale for insomnia symptoms. Participants self-report their difficulty falling asleep, difficulty maintaining sleep, early awakening, and the severity of these symptoms' impact on daily life. Each item on the ISI is scored on a 5-point Likert scale (0-4 points), with the total score ranging from 0 to 28 points. Higher score indicates more severe insomnia.

  Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.

• Pittsburgh Sleep Quality Index

  Pittsburgh Sleep Quality Scale (PSQI) was utilized to assess the level of sleep disturbances for adults. The PSQI is a 19-item self-administered questionnaire scored on a Likert scale from 0 to 3. Higher score indicates greater sleep disturbances.

  Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.

• Patient Health Questionnaire 9-item

  The Patient Health Questionnaire 9-item (PHQ-9) scale contains 7 items to assess the level of depression over the past two weeks. Each item is rated on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day). The scale score range is 0 to 27. Higher score indicates more severe depression level.

  Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.

• Generalized Anxiety Disorder 7 Item

  Generalized Anxiety Disorder 7 Item (GAD-7) consists of 7 questions asking about anxiety symptoms or feelings over the past two weeks. Each question is scored on a 4-point Likert scale, ranging from 0 (never) to 3 (almost every day), with a score range of 0 to 21. Higher score indicates greater level of anxiety.

  Assessments will be conducted at baseline (pre-intervention), post-intervention, and at a one-month follow-up after the four-week intervention period.

Secondary Outcomes (1)

• User acceptance and satisfaction with the chatbot-assisted intervention

  After four weeks intervention

Study Arms (2)

Receiving BBT-I intervention combined with a chatbot support

EXPERIMENTAL

Behavioral: Nurse-Led Chatbot-Enhanced BBT-I

Self-monitoring control group

NO INTERVENTION

Participants are only required to self-monitor their sleep patterns and join a chatbot group for contact.

Interventions

Nurse-Led Chatbot-Enhanced BBT-I BEHAVIORAL

An in-person, nurse-led Brief Behavioral Treatment for Insomnia (BBT-I) intervention, supplemented by an chatbot that provides educational content and remote, two-way interactive support.

Receiving BBT-I intervention combined with a chatbot support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 or older
• Self-reported have sleep disturbances, such as: difficulty falling asleep, difficulty maintaining sleep, waking up too early and being unable to fall asleep

You may not qualify if:

• Individuals with cognitive impairment who are unable to communicate in Mandarin or Taiwanese
• Individuals lack the ability to use smartphones to join the chatbot group

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Public classrooms, meeting rooms, or community activity centers

Taipei, Taiwan

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

Fen He Lin, Ph.D. candidate

CONTACT

+886 955 092 848; smallbox0955092848@gmail.com

Jung Chen Chang, Ph.D.

CONTACT

886-2-23123456; jungchenchang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)