Clinical Research On The Remote Cognitive Behavioral Therapy For Patients With Chronic Insomnia

Background and Objective:Insomnia is a global public health problem that approximately one-third of adult population has complaints of sleep disruption,such as difficulty falling sleep,early morning awakening but cannot return to sleep again,nonrestorative sleep,difficulty maintaining sleep(frequent nocturnal awakenings),a great degree functional impairments such as fatigue,sleepiness,drowsiness,energy shortage.Persistent insomnia and short sleep duration can cause great harm to the body,which is associated with increased risk of anxiety disorder,depression,hypertension,diabetes,suicide and drug abuse or dependence.And several studies showed that the direct or indirect costs of insomnia are much too high.The most common treatments with chronic insomnia are pharmacological treatment and cognitive behavioral therapy(CBT).Pharmacological therapy produces rapid symptomatic relief,it's effective immediately,but drug therapy cannot solve the etiology of insomnia,and there were a lot of adverse events include dizziness,residual daytime sedation,rebound insomnia and cognitive impairment and so on.Long term pharmacotherapy may be cause dependence,tolerance and difficult to withdraw.Cognitive behavioral therapy for insomnia(CBTI)primarily aimed at the pathogenesis,to correct the non-adaptive bad sleep habits and unrealistic cognitive and belief about sleep.Consequently relieve patient's negative emotion,eliminating conditional awaking,to establish conditional and procedural sleep patterns.CBTI and pharmacological therapy were found to have comparable efficacy in short term.Multiple researches indicate that approximately 80% of patients show benefits from CBTI,about 40% of patients achieve remission from insomnia,and CBTI avoid the side effects of drug treatment.Though traditional face-to-face CBTI yield large effect size but some barriers hinder its application in the insomnia patients such as high costs,lack of qualified therapists,stigmatization in receiving psychological and geographical remoteness.Therefore,how to take effective measures to make CBTI widely applied is the main task.Most clinical trials have used self-help treatments in the form of pamphlets or internet-delivered modalities to replace face-to-face treatment.Meta-analysis researches showed that Internet-based cognitive behavioral therapy for insomnia(ICBTI)appears to be an effective and promising treatment for chronic somatic conditions to improve physical and psychological functioning.In view of the elderly accounted for most of insomnia patients in our country and the Internet are not yet widely available in the whole society,therefore,there has the certain difficulty to popularize ICBTI.While the smart phone has been widely applied in China,therefore,the pattern of remote-interactive CBTI delivered by smart phones was used to cure chronic insomnia patients,the treatment measures in the form of text,video and other forms via the mobile platform delivered to the patients,and communicating with patients online,observing the clinical effect.Methods:62 participants with chronic insomnia to our outpatient clinics were recruited from November 2014 to June 2015 and randomly divided into three groups,21 patients received remote-interactive CBTI and pharmacological therapy(combined treatment group),20 patients received remote-interactive CBTI only(CBTI group),while the other 21 patients as drug treatment group received only drug therapy.All participants were informed of the relevant treatment procedure and signed informed consent.Included criteria were(1)Patients must meet the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders(Fifth Edition)(DSM-?)for chronic insomnia;(2)Male or female,age 18-80 years old;(3)No serious psychological conflicts and unresolved life events(in addition to the fear of sleep).Exclusion criteria included:(1)Untreated medical illness that interfered with sleep,was likely to be causally related to the insomnia;(2)Severe anxiety disorder,depression disorder,bipolar disorder,suicidal tendencies and other mental disorders and can't cooperate with treatment;(3)Drug or alcohol abuse,dependence;(4)Once received cognitive behavioral treatment for insomnia;(5)Pregnancy,breast-feeding women;(6)Illiteracy.All patients underwent semi-structured interviews to collect basic information and baseline data before treatment.Sleep related questionnaires were required to complete before and after treatment,which included Pittsburgh Sleep Quality Index(PSQI),Insomnia severity index(ISI),Hamilton anxiety scale(HAMA),Hamilton depression scale(HAMD),Dysfunctional beliefs and attitudes about sleep(DBAS-16).The entire course of treatment lasting record sleep diary,a standard sleep diary collected information included Sleep onset latency(SOL),Number of awaking(NOA),Wake time after sleep onset(WASO),Total sleep time(TST)and Sleep efficiency(SE),as well as frequency of medication use.In addition,we calculated the proportion of the patients who were able to cease the medicine at the end of the treatment.Patients in the CBTI group or combined treatment group received five treatment modules with smart phone intervention by experienced therapists in six to eight weekly 15-to 60-min sessions,contingent on treatment response.To understand the treatment effect,therapists need to make interactive communication with patients at least 1-3 times every week.Patients randomized to drug treatment group followed the standard clinical treatment protocol,under which insomnia specialist physicians offered appointments to prescribe or discontinue prescriptions during at least 6-8 weeks of the treatment period.The patients allocated to drug treatment group received no treatment other than pharmacological treatment and information about tapering their medication.The remote-interactive treatment was organized into 5 modules: Stimulus control,sleep restriction,sleep hygiene education,relaxation training and cognitive therapy.The main categories of drugs for the treatment were benzodiazepine receptor agonists,there was no significant difference of drug type and regimen between combined treatment group and drug treatment group at pretreatment.Results:1.After 4-week treatment phase,simple effects analysis revealed significant improvements from baseline to the 4-week treatment phase in SOL,NOA,WASO,TST and SE for the combined treatment group and drug treatment group but not CBTI group(p<0.05).For SOL,WASO and SE significant improvements also were observed for the CBTI group(p<0.05).There was no significant improvement in NOA and TST in CBTI group after 4-week treatment(p>0.05).There was no difference among the three groups in SOL,NOA,WASO and SE at 4-week posttreatment(p>0.05),while the combined treatment group and drug treatment group had significantly greater improvement in TST compared to CBTI group at 4-week posttreatment(p<0.05).A significant decrease in the frequency of hypnotics at 4-week posttreatment was observed in only the combined treatment group(p<0.05).2.There were significant differences among the three groups in SOL,WASO,NOA,TST and SE from baseline to posttreatment(p<0.05).No significant difference was found in NOA and TST among the three groups(p>0.05).The combined treatment group and CBTI group had significantly greater improvements in SOL,WASO and SE compared to drug treatment group at posttreatment(p<0.05).A significant decrease in the frequency of hypnotics at posttreatment was observed in the combined treatment group(p<0.05).3.With 6-8 weeks treatment,the PSQI,ISI,HAMA,HAMD and DBAS-16 scores significantly decreased at the end of the treatment in both three groups(p<0.05),but the reduction in the scores of DBAS-16 at the end of treatment was significant larger in the combined treatment group and CBTI group than in the drug treatment group(p<0.05).4.After the whole treatment,6 patients(29%)in the combined treatment group were able to discontinue the medicine,while only one patient(5%)in the drug treatment group had that same outcome.OR was 7.286(95% CI:0.782-67.895)for the cessation medicine.Conclusions:1.Remote-interactive CBTI can significantly reduce the SOL,WASO,and the NOA,increasing TST and improving SE in the patients with chronic insomnia as well as relieve the symptoms of anxiety and depression,and correct the maladaptive sleep behavior and unreasonable cognition about sleep.2.The dropout rate is lower in combined treatment group than that in drug treatment group,and the withdrawal rate is higher than drug treatment group.3.Remote-interactive CBTI was effective and acceptable for treating chronic insomnia in the Chinese population,combination with the pharmacological therapy during acute therapy can further enhance the efficacy and rapidly reduce insomnia,anxiety and depression symptoms as well as the dose of hypnotic medication.