Clinical trial NCT03309527: E-aid Sleep-focused TrEatment for Prevention of Major Depression (STEP-MD)
Official title: A Double-blind Randomized Controlled Study on Influence of E-aid Cognitive Behavioral Therapy for Insomnia to Reduce Incidence of Depression as Well as Suicidal Ideation in Patients With Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Depression
Self Harm
Keywords: insomia
Depression
Self Harm
Suicide
guided self-help
psychological treatment
eCBTI
internet
Psychotherapy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm parallel design involves two groups of participants with insomnia. One group receives internet delivered sleep hygiene education, and the other group receives internet delivered cognitive behavior therapy.
Primary purpose: TREATMENT

Brief summary: In the past, there were studies on relationship between insomnia and depression, and those studies found that depression can be the result of untreated insomnia. Mostly insomnia precedes depression, and is a marker for recurrence of depression. Research suggests that insomnia may cause depression by changing the emotional response.

In this study, investigators will establish the national online cognitive behavioral therapy for insomnia (e-aid Cognitive Behavioral Therapy for Insomnia, eCBTI ) tools, and online health education on sleep (e-aid Sleep Hygiene Education, eSHE ) tools for controls. Investigators will be testing whether eCBTI can reduce the incidence of depression in patients with sleep disorders, increasing remission rate of depression, and a corresponding reduction in suicidal ideas, compared with eSHE control groups.

Detailed description: 1000 patients suffering from insomnia will be recruited in this study.Participants with insomnia will be taken from: A. the WeChat platform, B. the customer group of intelligent hardware/software, and C.outpatient department. 1000 participants with insomnia will be randomly divided into eCBTI group and eSHE group equally that each group will have 500 participants.

Participants will be requested to accept online structured questionnaire, including social and demographic data and insomnia disorders diagnosis process (adapted from "A guide to diagnosis and treatment of insomnia in China"). If the interviewee meets the criteria of entry, then participants are requested to fill online informed consent and then enrolled into the baseline assessment.

Baseline assessment includes two parts:

1, Self-reported questionnaire: Insomnia Severity Index, ISI, Dysfunctional Beliefs and Attitudes about Sleep, DBAS, Sleep Hygiene and Practices Scale, SHPS, Pre - Sleep Arousal Scale, PSAS, Epworth Sleepiness Scale, ESS, Hospital Anxiety and Depression Scale, HADS, Short - Form 12 - Item Health Survey, SF - 12; 2. Researcher Interview: Clinical Interview of depression in the Mini International Neuropsychiatric Interview (MINI).

Therapeutic intervention: Both groups will be treated for 4 weeks, and multiple follow-up visits within 12 months.

The research specifically tailored the third-party application of the smartphone to complete the online insomnia therapy program. The eCBTI group and the eSHE group included four weeks of core courses: daily listening to five minutes of sleep hygiene education, and recording sleep diaries. Every week, eCBTI group will receive guided individual customized sleep restriction and stimulus control therapy whereas eSHE group will be given sleep health education and the guidance regarding questionnaires.

Previous studies have shown that the annual prevalence of depression in people with insomnia is about 2 to 3 percent. Based on investigators previous research results, new cases of depression were 7.4%, and patients with chronic insomnia eCBTI treatment can effectively reduce the depression incidence rate by 50%, such as the need to achieve 80% Confidence Interval at p-value of 0.05, 300 patients will be needed in each group. Considering the loss rate of about 30-40%, the study required 500 cases per group (eCBTI group and eSHE group) in the baseline.

Outcomes will be measure in continuous variable data with mean and standard deviation (SD), classifying data with numerical value or percentage. Compare parametric data and non-parametric data (2 groups) through independent t-test. The variance analysis of repeated measures will be used to compare the difference between the two groups in treatment and follow-up (e.g., ISI, etc.). The 2 classification variables of clinical results will be calculated by survival analysis, such as the new suicidal thoughts in two groups. Bilateral 5% significance level is statistically significant. All statistical programs are implemented in the 22.0 version of the social science statistical package (IBM SPSS 22.0) that runs in Windows.

Eligibility criteria: Inclusion Criteria:

* the diagnostic criteria for insomnia in accordance with DSM-5
* 18 years or older
* compliant and have a good understanding of research program
* able to fill the online informed consent form
* owns and have a good command on electronic gadgets (e.g., smart phones, tablets, computers, etc.)

Exclusion Criteria:

* clear and unhealed physical, mental and/or sleep disorders requiring acute care
* is taking psychotherapy for insomnia
* shift workers, regular night shift workers, frequent time zone fliers (such as crew members on international flights)

Primary outcomes:
measure: occurrence of depression
timeFrame: changes of occurrence of depression from baseline to 2weeks, 5 weeks, 6 months and 12 months.
Secondary outcomes:
measure: Treatment adherence rating scale
timeFrame: changes of scale score from baseline to 6 months and 12 months
measure: Treatment satisfaction rating scale (TSRS)
timeFrame: changes of scale score from baseline to 6 months and 12 months
measure: Changes in Insomnia Severity Index(ISI)
timeFrame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
measure: Changes in Hospital Anxiety and Depression Scale (HADS)
timeFrame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
measure: Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
timeFrame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
measure: Changes in Short - Form 12 - Item Health Survey（SF-12）
timeFrame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
measure: Changes in Sleep Hygiene and Practices Scale(SHPS)
timeFrame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
measure: Changes in Pre-Sleep Arousal Scale(PSAS)
timeFrame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
measure: Changes in Epworth Sleepiness Scale(ESS)
timeFrame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
measure: occurrence of suicidal ideation
timeFrame: changes of occurrence of suicidal ideation from baseline to 2 weeks, 5 weeks, 6 months and 12 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: