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

NCT ID: NCT03302455

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2019-06-02

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

Detailed Description

Insomnia patients are collected from: Outpatients from Sleep clinics. Included 200 cases of acute insomnia patients, the participants will randomly divided into 100 brief eCBTI Group and 100 patients with control group, brief eCBTI Group will receive 1 Week eCBTI intervention and control group will not receive any intervention. Both groups will receive 3 months of follow-up.

At week 2, ISI and HADS will be conducted. Brief eCBTI group will also complete Treatment Component Adherence Scale (TCAS) in order to assess treatment adherence to and perceived helpfulness of each therapeutic element. At 3 months, two groups of subjects will have baseline assessment(except socio-demographic information), including chronic insomnia disorder diagnosis and self evaluation form (ISI, DBAS, SHPS ,PSAS,FIRST,ESS,HADS,SF-12v2).

This study provides a Smartphone to complete third-party applications online insomnia treatment procedures. Brief eCBTI includes 1-week core curriculum: sleep hygiene education, sleep restriction, stimulus control, relaxation audios, cognitive components, information about sleeping pills, and a brief overview.

Previous studies have shown that approximately 40% of acute insomnia will turn into Chronic insomnia disorder.While our preliminary work suggests, with the extension of follow-up time, high rates of chronic insomnia may be more ( 52.3% ).In order to meet the 95% confidence intervals (Confidence Interval, CI )( 35%-49% ) requirement, the project needs 200 acute insomnia disorder subjects, and random access eCBTI Treatment group and the control group (100 Cases) of whom an estimated 70% or more participants can complete 3 months of follow-up. This sample size ensures continuous data of small sample (Cohen d = 0.30) statistical effect is greater than 0.8, And test the odds ratio of dichotomous variables (Odds Ratio, OR) greater than 1.50(p>0.05 ).

Mean value for continuous variable data ± Standard deviation, Numerical or categorical variable data expressed as a percentage. T test for the continuous variables and Chi Square test for the categorical variables will be used. Using repeated measures analysis of variance to compare two sets of continuous variables in the treatment and follow-up of changes in the process (such as ISI score, etc). Incidence of chronic insomnia is computed using Chi Square test. All statistical procedures are used in Windows running 26.0 version of the SPSS package (IBM SPSS 26.0).

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

eCBTI

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

Group Type: EXPERIMENTAL

eCBTI

Intervention Type: 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.

Control

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eCBTI

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bin Zhang, MD & PhD

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 31740476 (View on PubMed)

Other Identifiers

NFEC-2017-131

Identifier Type: -

Identifier Source: org_study_id