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InsomniaNCT03309527

E-aid Sleep-focused TrEatment for Prevention of Major Depression (STEP-MD)

A study testing e-aid Cognitive Behavior Therapy and e-aid Sleep Hygiene Education in people with Insomnia and Depression, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Insomnia, Depression, Self Harm
What is being tested?
e-aid Cognitive Behavior Therapy and e-aid Sleep Hygiene Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteChina
Study dates
1 Nov 2017to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

China1 site
  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong

Other trials in China

About this study

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

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.

Read the 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.

Being tested
e-aid Cognitive Behavior Therapy, e-aid Sleep Hygiene Education
Keywords
insomia, Depression, Self Harm, Suicide, guided self-help, psychological treatment, eCBTI, internet, Psychotherapy
Medical subject headings
Sleep Initiation and Maintenance Disorders, Depression, Self-Injurious Behavior, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-aid Cognitive Behavior TherapyBehavioural

    e-aid Cognitive Behavior Therapy

  • e-aid Sleep Hygiene EducationBehavioural

    e-aid Sleep Hygiene Education

Study groups in NCT03309527
Study groupRoleWhat they receive
e-aid Cognitive Behavior TherapyExperimentalParticipants receive e-aid cognitive behavior therapy. Every week, this group will receive researcher guided individual customized sleep restriction and stimulus control therapy.
Receives: Behavioral: e-aid Cognitive Behavior Therapy
e-aid Sleep Hygiene EducationActive comparatorParticipants 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.
Receives: Behavioral: e-aid Sleep Hygiene Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. occurrence of depression

    Clinical Interview of depression in the Mini-International Neuropsychiatric Interview (MINI) by investigators by telephone or online.

    Measured: changes of occurrence of depression from baseline to 2weeks, 5 weeks, 6 months and 12 months.

Secondary outcomes (10)
  1. 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)

    Measured: changes of scale score from baseline to 6 months and 12 months

  2. 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).

    Measured: changes of scale score from baseline to 6 months and 12 months

  3. 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.

    Measured: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.

  4. 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.

    Measured: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.

  5. 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.

    Measured: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.

  6. 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.

    Measured: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.

  7. 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 .

    Measured: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.

  8. 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.

    Measured: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.

  9. 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.

    Measured: changes of scale score from baseline to 2 weeks, 5 weeks, 6 months and 12 months.

  10. occurrence of suicidal ideation

    Clinical Interview of suicidal ideation in the Mini-International Neuropsychiatric Interview (MINI) by investigators by telephone or online.

    Measured: changes of occurrence of suicidal ideation from baseline to 2 weeks, 5 weeks, 6 months and 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2017
  2. Study start1 Nov 2017
  3. Primary completionOct 2019 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03309527
Sponsor's protocol ID
NFEC-2017-132
Status last verified
Feb 2018
First submitted
25 Sep 2017
Last updated
1 Mar 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing e-aid Cognitive Behavior Therapy and e-aid Sleep Hygiene Education in people with Insomnia and Depression, run by Nanfang Hospital, Southern Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

occurrence of depression (time frame: changes of occurrence of depression from baseline to 2weeks, 5 weeks, 6 months and 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2018.

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