Clinical trial NCT03302455: E-aid Cognitive Behavior Therapy for Insomnia to Prevent Transition From Acute Insomnia to Chronic Insomnia in China
Official title: A Randomized Controlled Study of E-aid Cognitive Behavior Therapy in Patients With Acute Insomnia to Prevent Transition to Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: insomia
eCBTI
internet
psychotherapy
guided self-help
psychological treatment
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives brief e-aid cognitive behavior therapy, and the other group does not receive any interventions during a clinical study.
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Incidence of chronic insomnia
timeFrame: 3 months
Secondary outcomes:
measure: Changes in Ford Insomnia Response to Stress Test (FIRST)
timeFrame: baseline and 3 months
measure: Changes in Short Form 12-Item Health Survey version 2（SF-12v2）
timeFrame: baseline and 3 months
measure: Changes in Sleep Hygiene and Practices Scale(SHPS)
timeFrame: baseline and 3 months
measure: Changes in Pre-Sleep Arousal Scale(PSAS)
timeFrame: baseline and 3 months
measure: Changes in Epworth Sleepiness Scale(ESS)
timeFrame: baseline and 3 months
measure: Changes in Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, week 2, and 3 months
measure: Treatment Component Adherence Scale (TCAS)
timeFrame: week 2
measure: Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
timeFrame: baseline and 3 months
measure: Changes in Insomnia Severity Index(ISI)
timeFrame: baseline，week 2, and 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Bin Zhang, MD & PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.