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

NCT03302455 | Completed

• 1 other identifier: NFEC-2017-131
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Insomnia

Keywords

insomia; eCBTI; internet; psychotherapy; guided self-help; psychological treatment

Outcome Measures

Primary Outcomes (1)

• Incidence of chronic insomnia

  the diagnostic criteria for chronic insomnia disorder according to DSM-5

  3 months

Secondary Outcomes (9)

• Changes in Ford Insomnia Response to Stress Test (FIRST)

  baseline and 3 months

• Changes in Short Form 12-Item Health Survey version 2（SF-12v2）

  baseline and 3 months

• Changes in Sleep Hygiene and Practices Scale(SHPS)

  baseline and 3 months

• Changes in Pre-Sleep Arousal Scale(PSAS)

  baseline and 3 months

• Changes in Epworth Sleepiness Scale(ESS)

  baseline and 3 months

Study Arms (2)

eCBTI

EXPERIMENTAL

This group will receive a 1-week of eCBTI treatment and will receive 3 months of follow-up.

Behavioral: eCBTI

Control

NO INTERVENTION

This group does not receive any interventions during first 3 months of clinical study. If the participants still have no remission from insomnia after 3 months, will be recommended to enter the standardized insomnia treatment (medication and / or non-drug treatment).

Interventions

eCBTI BEHAVIORAL

The brief eCBTI contains a one-week core course: sleep hygiene education, sleep restriction, stimulus control, relaxation audios, cognitive components, information about sleeping pills, and a brief overview. In addition, individual customized sleep restriction and stimulation control treatments were provided according to the subject's previous 2-week sleep status.

eCBTI

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Yang Y, Luo X, Paudel D, Zhang J, Li SX, Zhang B. Effects of e-aid cognitive behavioural therapy for insomnia (eCBTI) to prevent the transition from acute insomnia to chronic insomnia: study protocol for a randomised controlled trial. BMJ Open. 2019 Nov 18;9(11):e033457. doi: 10.1136/bmjopen-2019-033457.

  PMID: 31740476 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Bin Zhang, MD & PhD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The independent researcher from the IT department who carries out the randomisation and allocation procedure will be blinded to the study protocol. Participants could not be blinded to treatment allocation as participants in the control group did not receive any intervention from this trial. The research team will have limited contact with both IT staff and study participants, therefore, will not be able to bias the allocation or the assessments. Statistical analyses will be carried out by an independent researcher from the Southern Medical University who is not involved with the randomisation and assessment procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group receives brief e-aid cognitive behavior therapy, and the other group does not receive any interventions during a clinical study.

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 5, 2017
• Study Start: November 1, 2017
• Primary Completion: June 2, 2019
• Study Completion: June 2, 2019
• Last Updated: October 20, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)