Brief Behavioral Intervention for Insomnia Among Adults With Sleep Disturbances
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nurse-Led Chatbot-Enhanced BBT-I.
- Who it may be relevant to
- Registry conditions: Sleep Disturbance, Insomnia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of a Nurse-led Brief Behavioral Intervention for Insomnia With Health Education Chatbot Assistance Among Community-dwelling Adults: a Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Sleep and health diary [Time frame: Daily self-recording during one month intervention period]
- 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.]
- 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.]
- 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.]
- 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.]
Secondary outcome measures (1)
- User acceptance and satisfaction with the chatbot-assisted intervention [Time frame: After four weeks intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Public classrooms, meeting rooms, or community activity centers — Taipei
Identifiers
NCT: NCT07603687 · 202603048RINE