An interventional study of e-aid Cognitive Behavior Therapy and e-aid Sleep Hygiene Education in Insomnia, Depression and Self Harm, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-01.
Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Treatment
Among 198 studies in Sleep Initiation and Maintenance Disorders with a site in China — 82 open to participants now, 88 under way, 2 of them phase 3. Sleep Initiation and Maintenance Disorders · China.
Among the 198 studies in Sleep Initiation and Maintenance Disorders with a site in China, this one is the 3rd largest by planned enrollment of the 162 interventional ones, is one of 9 that started in 2017, is one of 123 with no phase, and was the 19th registered.
2,722 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 726 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 68 across 2,350 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →82 of the 198 studies in Sleep Initiation and Maintenance Disorders with a site in China are open now, in 1 country. Each count lists the studies.
Of the 386 Sleep Initiation and Maintenance Disorders studies recruiting now, 152 (39%) set no upper age limit and 204 (53%) stop at 75 or younger; 59 take children under 18; 108 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →198 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 9 started in 2017.
Median enrollment 88 across the 162 interventional studies, 200 across the 36 observational. Of the 82 that completed or were terminated, 2 (2%) have results posted.
19 of 198 have an industry lead sponsor. The 10 most frequent:
Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
Nanfang Hospital, Southern Medical University has 6 studies filed under Sleep Initiation and Maintenance Disorders — fewer than ten, so there is no comparison to draw.
29 of the studies in Sleep Initiation and Maintenance Disorders with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07738809Capital University of Physical Education and Sports, ChinaEffects of Exercise Intervention on Sleep Quality and Emotional Problems in College Students With Depressive Symptoms | 2026-11 |
| NCT07730762Xijing HospitalA Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During Pregnancy | 2026-11-30 |
| NCT07340268Zan WangThe Effects of Transcranial Current Stimulation on Insomnia | 2026-11-30 |
| NCT07868224Jiangxi University of Traditional Chinese MedicineValidating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials | 2026-12-01 |
| NCT07384429YangPanEffects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease | 2026-12-01 |
Among the 198 studies in Sleep Initiation and Maintenance Disorders with a site in China, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive e-aid cognitive behavior therapy. Every week, this group will receive researcher guided individual customized sleep restriction and stimulus control therapy.
Behavioral: e-aid Cognitive Behavior Therapy
Participants receive e-aid sleep hygiene education which consists of general sleep health education and the guidance on questionnaires. Every week, this group will receive researcher guided sleep hygiene.
Behavioral: e-aid Sleep Hygiene Education
e-aid Cognitive Behavior Therapy
e-aid Sleep Hygiene Education
occurrence of depression
Clinical Interview of depression in the Mini-International Neuropsychiatric Interview (MINI) by investigators by telephone or online.
Time frame: changes of occurrence of depression from baseline to 2weeks, 5 weeks, 6 months and 12 months.
Treatment adherence rating scale
A self-reported questionnaire will be administered posttreatment to assess adherence to CBTI guidelines and the perceived helpfulness of treatment guidelines. Adherence to each therapeutic element will be rated on a 0 to 3 scale as follows: (0) Followed rarely or not at all; (1) Followed occasionally; (2) Followed most of the time; (3) Followed consistently. Ratings for all therapeutic elements will be broadly grouped into a Behavioral Component and a Cognitive Component. The Behavioral Component consists of stimulus control and sleep restriction guidelines and will include the following 4 items: adhering to a fixed prescribed bedtime, getting out of bed when unable to sleep, using the bed only for sleep, and restricting the amount of time spent in bed (Cronbach α = 0.50). The Cognitive Component consists of endorsement of 2 items: "Changing my expectations about sleep" and "Changing the way I think about not sleeping" (Cronbach α = 0.83)
Time frame: changes of scale score from baseline to 6 months and 12 months
Treatment satisfaction rating scale (TSRS)
Subjects' satisfaction to the treatment measured by Treatment satisfaction rating scale.The Consumer Report Treatment satisfaction scale will be adapted for insomnia in the study as: "How much do you feel the insomnia treatment program has helped you in the following areas?" The areas will include insomnia, energy level, work productivity, coping, life enjoyment, hopefulness, self-esteem, and mood. Each item will be rated on a 5 point Likert scale, with 1 = Made things a lot better; 2 = Made things somewhat better; 3 = Made no difference; 4 = Made things somewhat worse; 5 = Made things a lot worse. All items on this measure will be coded such that higher scores indicates greater symptom improvement. Overall treatment satisfaction was computed as the average score on all 7 items of the TSRS, which provided an index of clinically significant improvement (Cronbach α = 0.86).
Time frame: changes of scale score from baseline to 6 months and 12 months
Changes in Insomnia Severity Index(ISI)
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. The dimensions evaluated are: severity of sleep onset, sleep maintenance, and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The internal consistency of the ISI was found to be excellent (Cronbach's = 0.74) and has been validated with both sleep diary and polysomnography. This outcome will be measured at 2 weeks, 5 weeks, 6 months and 12 months in both the eCBTI and eSHE groups.
Time frame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
Changes in Hospital Anxiety and Depression Scale (HADS)
The HADS is a self-report questionnaire to determine the levels of anxiety and depression that a participant is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal. A cut-off point of 8/21 for anxiety or depression will be used. For anxiety (HADS-A) this gave a specificity of 0.78 and a sensitivity of 0.9. For depression (HADS-D) this gave a specificity of 0.79 and a sensitivity of 0.83.This outcome will be measured at 2 weeks, 5 weeks, 6 months and 12 months in both the eCBTI and eSHE groups.
Time frame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
Changes in Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS)
The DBAS is a 30-item self-report questionnaire designed to evaluates sleep-related beliefs, querying respondents' expectations and attitudes regarding the causes, consequences, and potential treatments of sleep issues. The 30-item version showed adequate psychometric properties as evidenced by good internal consistency (Cronbach Alpha = 0.80), moderate item-total correlations (mean rs = 0.37), and adequate convergent and discriminant validity.Likert-type scale requiring participants to choose from 0 (strongly disagree) to 10 (strongly agree) will be used. Thus, the results are quantified in terms of strength of endorsed beliefs. A higher score indicates more dysfunctional beliefs and attitudes about sleep. The total score is based on the average score of all items.
Time frame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
Changes in Short - Form 12 - Item Health Survey（SF-12）
The SF-12 is a 12-item self-report questionnaire used to assess generic health outcomes from the patient's perspective.The SF-12 addresses the 8 domains viz. Physical functioning (PF), Role - physical (RP),Bodily pain (BP),General health perceptions (GH),Vitality (V),Social functioning (SF),Role - emotional (RE) and Mental health (MH) . The 2 scores that will be obtained from this assessment are composite scores representing physical health and mental health composite summaries, PCS and MCS respectively. An algorithm will be used to generate the physical and mental health composite scores for comparison to normative data. In normative data, the mean score is set to 50, thus scores \> 50 indicate better physical or mental health than the mean and scores \< 50 indicate worse health.
Time frame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
Changes in Sleep Hygiene and Practices Scale(SHPS)
Subjects' general sleep hygiene and practices are measured with Sleep Hygiene and Practices Scale.The SHPS is a 13-item self-report measure designed to assess the practice of sleep hygiene behaviors. Each item is rated on a five-point scale ranging from 0 (never) to 4 (always). Total scores range from 0 to 52, with a higher score representing poorer sleep hygiene. SHPS has shown adequate reliability and validity .
Time frame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
Changes in Pre-Sleep Arousal Scale(PSAS)
Participant's problems during initiation of sleep is assessed with Pre-Sleep Arousal Scale.The Pre-Sleep Arousal Scale (PSAS) is a brief self-administered measure in which participants rate the intensity of experienced arousal. Internal consistency for somatic (8 items) and cognitive (8 items) subscales are satisfactory (α = 0.81 and α = 0.76) respectively.
Time frame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
Changes in Epworth Sleepiness Scale(ESS)
Subjective measure of a patient's sleepiness is measured with Epworth Sleepiness Scale.The Epworth Sleepiness Scale is a self-report 8-item questionnaire producing scores from 0 to 24. Scores greater than 10 suggest significant daytime sleepiness. The Epworth Sleepiness Scale has good psychometric properties , correlates with objective measures of sleepiness , and has been shown to differentiate between individuals with and without sleep disorders and those who are and are not sleep deprived.
Time frame: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
occurrence of suicidal ideation
Clinical Interview of suicidal ideation in the Mini-International Neuropsychiatric Interview (MINI) by investigators by telephone or online.
Time frame: changes of occurrence of suicidal ideation from baseline to 2 weeks, 5 weeks, 6 months and 12 months.
Plan to share: Undecided
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Started Nov 2017 (actual). Primary completion is estimated for Oct 2019, 23 months after the start.
Of 1,207 non-industry interventional studies with no phase under Sleep Initiation and Maintenance Disorders, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 35. This study's planned 23 months is above that.
Counting every sponsor, half of 1,285 studies reached it within 15 months; a quarter within 6 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders →
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