Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances

Effectiveness of a Nurse-led Brief Behavioral Intervention for Insomnia With Health Education Chatbot Assistance Among Community-dwelling Adults: a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Sleep Disturbance
• Intervention / Treatment: Behavioral: Nurse-Led Chatbot-Enhanced BBT-I

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fen He Lin, Ph.D. candidate; Phone Number: +886 955 092 848; Email: smallbox0955092848@gmail.com
• Study Contact Backup: Name: Jung Chen Chang, Ph.D.; Phone Number: 288905 886-2-23123456; Email: jungchenchang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Public classrooms, meeting rooms, or community activity centers
    • Contact: Fen He Lin, Ph.D. candidate; Phone Number: +886 955 092 848; Email: smallbox0955092848@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Receiving BBT-I intervention combined with a chatbot support	Behavioral: Nurse-Led Chatbot-Enhanced BBT-I; 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.
No Intervention: Self-monitoring control group; Participants are only required to self-monitor their sleep patterns and join a chatbot group for contact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
User acceptance and satisfaction with the chatbot-assisted intervention	Based on the six dimensions of the Healthcare Information System (HIS) success model proposed by DeLone and McLean (2003), a questionnaire was designed to assess the intervention group's satisfaction with and acceptance of the education chatbot. This self-administered tool utilized a 5-point Likert scale (ranging from 1 to 5), where higher scores indicate greater acceptance and satisfaction.	After four weeks intervention

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: sleep disturbance; Brief Behavioral Treatment for Insomnia
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 202603048RINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No