Depression Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Recruiting |
NCT04977232 -
Adjunctive Game Intervention for Anhedonia in MDD Patients
|
N/A | |
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Recruiting |
NCT03207828 -
Testing Interventions for Patients With Fibromyalgia and Depression
|
N/A | |
Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
Recruiting |
NCT06011681 -
The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
|
||
Completed |
NCT04476446 -
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
|
Phase 3 | |
Recruiting |
NCT02783430 -
Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease
|
Phase 2/Phase 3 | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04598165 -
Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05006976 -
A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study
|
N/A | |
Enrolling by invitation |
NCT03276585 -
Night in Japan Home Sleep Monitoring Study
|
||
Completed |
NCT03167372 -
Pilot Comparison of N-of-1 Trials of Light Therapy
|
N/A | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A |