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NCT Number: NCT07603687

Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances

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.

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Key information

Conditions

Sleep Disturbance Dyssomnias Insomnia Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sleep and health diary

    Time frame: Daily self-recording during one month intervention period

    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.

  2. Insomnia Severity Index

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

    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.

  3. Pittsburgh Sleep Quality Index

    Time frame: 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 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.

  4. Patient Health Questionnaire 9-item

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

    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.

  5. Generalized Anxiety Disorder 7 Item

    Time frame: 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 (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.

Secondary outcomes

  1. User acceptance and satisfaction with the chatbot-assisted intervention

    Time frame: After four weeks 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fen He Lin, Ph.D. candidate

CONTACT

[email protected]

+886 955 092 848

Jung Chen Chang, Ph.D.

CONTACT

[email protected]

886-2-23123456 ext. 288905

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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