CompletedNot Applicable

E-aid Cognitive Behavior Therapy for Insomnia to Prevent Transition From Acute Insomnia to Chronic Insomnia in China

China192 participantsStarted 2017-11-01

Plain-language summary

Acute insomnia is one of the most common sleep disorders. Online cognitive behavioral therapy for insomnia (e-aid Cognitive Behavioral Therapy for Insomnia, eCBTI) has received wide attention in recent years. Foreign countries already have some eCBTI treatment tool, shown similar efficacy as standard CBTI, but how eCBTI can help in acute insomnia require further exploration and examination. In this study, Investigators will establish eCBTI treatment tool to test whether eCBTI can reduce the conversion of acute insomnia to chronic insomnia disorder; and whether they can improve insomnia symptoms, sleep-related symptoms, anxiety and depressive symptoms, and quality of life

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical diagnosis for acute insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5); * Must be eighteen years or older; * Must be able to comply with the intervention; * Must be able to provide informed consent; * Owning smart devices (such as smartphones and tablets). Exclusion Criteria: * A significant untreated mental or medical illness (e.g. consciousness disturbances, mania, acute phase of schizophrenia, major depressive disorder); * Received any kind of psychological treatment for insomnia in the past 6 months; * Shift workers, frequent cross-time flyers (e.g. shifted nurse/health professionals, international flight crew). To allow for greater generalisability, this study does not exclude patients with a stable condition of somatic disease, mental disorders (eg, depression in remission), or individuals receiving pharmacological treatments (eg, antihypertensive drugs, antidepressants and benzodiazepines).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of chronic insomnia

Timeframe: 3 months

Trial details

NCT IDNCT03302455

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-02

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