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Internet-guided cognitive, behavioral and chronobiological interventions in depression-prone insomnia subtypes: protocol of a randomized controlled prevention trial.

ABSTRACT: BACKGROUND:Major depressive disorder is among the most burdening and costly chronic health hazards. Since its prognosis is poor and treatment effectiveness is moderate at best, prevention would be the strategy of first choice. Insomnia may be the best modifiable risk factor. Insomnia is highly prevalent (4-10%) and meta-analysis estimates ±13% of people with insomnia to develop depression within a year. Among people with insomnia, recent work identified three subtypes with a particularly high lifetime risk of depression. The current randomized controlled trial (RCT) evaluates the effects of internet-guided Cognitive Behavioral Therapy for Insomnia (CBT-I), Chronobiological Therapy (CT), and their combination on insomnia and the development of depressive symptoms. METHODS:We aim to include 120 participants with Insomnia Disorder (ID) of one of the three subtypes that are more prone to develop depression. In a two by two factorial repeated measures design, participants will be randomized to CBT-I, CT, CBT-I?+?CT or treatment as usual, and followed up for one year. The primary outcome is the change, relative to baseline, of the severity of depressive symptoms integrated over four follow-ups spanning one year. Secondary outcome measures include a diagnosis of major depressive disorder, insomnia severity, sleep diaries, actigraphy, cost-effectiveness, and brain structure and function. DISCUSSION:Pre-selection of three high-risk insomnia subtypes allows for a sensitive assessment of the possibility to prevent the development and worsening of depressive symptoms through interventions targeting insomnia. TRIAL REGISTRATION:Netherlands Trial Register (NL7359). Registered on 19 October 2018.

SUBMITTER: Leerssen J

PROVIDER: S-EPMC7160982 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Internet-guided cognitive, behavioral and chronobiological interventions in depression-prone insomnia subtypes: protocol of a randomized controlled prevention trial.

Leerssen Jeanne J Foster-Dingley Jessica C JC Lakbila-Kamal Oti O Dekkers Laura M S LMS Albers Anne C W ACW Ikelaar Savannah L C SLC Maksimovic Teodora T Wassing Rick R Houtman Simon J SJ Bresser Tom T Blanken Tessa F TF Te Lindert Bart B Ramautar Jennifer R JR Van Someren Eus J W EJW

BMC psychiatry 20200415 1

<h4>Background</h4>Major depressive disorder is among the most burdening and costly chronic health hazards. Since its prognosis is poor and treatment effectiveness is moderate at best, prevention would be the strategy of first choice. Insomnia may be the best modifiable risk factor. Insomnia is highly prevalent (4-10%) and meta-analysis estimates ±13% of people with insomnia to develop depression within a year. Among people with insomnia, recent work identified three subtypes with a particularly ...[more]

PMID: 32293363

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Project description:BackgroundMajor depressive disorder is a chronic condition; its prevalence is expected to grow with the aging trend of high-income countries. Internet-based cognitive-behavioral therapy has proven efficacy in treating major depressive disorder.ObjectiveThe objective of this study was to assess the cost-effectiveness of implementing a community internet-based cognitive behavioral therapy intervention (Super@, the Spanish program for the MasterMind project) for treating major depressive disorder.MethodsThe cost-effectiveness of the Super@ program was assessed with the Monitoring and Assessment Framework for the European Innovation Partnership on Active and Healthy Ageing tool, using a 3-state Markov model. Data from the cost and effectiveness of the intervention were prospectively collected from the implementation of the program by a health care provider in Badalona, Spain; the corresponding data for usual care were gathered from the literature. The health states, transition probabilities, and utilities were computed using Patient Health Questionnaire-9 scores.ResultsThe analysis was performed using data from 229 participants using the Super@ program. Results showed that the intervention was more costly than usual care; the discounted (3%) and nondiscounted incremental cost-effectiveness ratios were €29,367 and €26,484 per quality-adjusted life-year, respectively (approximately US $35,299 and $31,833, respectively). The intervention was cost-effective based on the €30,000 willingness-to-pay threshold typically applied in Spain (equivalent to approximately $36,060). According to the deterministic sensitivity analyses, the potential reduction of costs associated with intervention scale-up would reduce the incremental cost-effectiveness ratio of the intervention, although it remained more costly than usual care. A discount in the incremental effects up to 5% exceeded the willingness-to-pay threshold of €30,000.ConclusionsThe Super@ program, an internet-based cognitive behavioral therapy intervention for treating major depressive disorder, cost more than treatment as usual. Nevertheless, its implementation in Spain would be cost-effective from health care and societal perspectives, given the willingness-to-pay threshold of €30,000 compared with treatment as usual.

Project description:ImportanceMany military service members and veterans report insomnia after sustaining traumatic brain injury (TBI). Limitations of first-line treatment, cognitive-behavioral therapy for insomnia (CBT-I), include availability of qualified clinicians, low completion rates, and cost.ObjectiveTo investigate the feasibility and efficacy of internet-guided CBT-I (eCBT-I) in military service members and veterans with insomnia and a history of TBI.Design, setting, and participantsThis randomized clinical trial of fully remote internet-based interventions and evaluations was conducted from September 1, 2020, to June 30, 2021, with 3 months of follow-up. Participants included a volunteer sample of military service members and veterans aged 18 to 64 years with a history of mild TBI/concussion and at least moderately severe insomnia defined as an insomnia severity index (ISI) score of greater than 14 and Pittsburgh Sleep Quality Index of greater than 4. Self-reported race, ethnicity, and educational level were generally representative of the US military. Data were analyzed from October 21, 2021, to April 29, 2024.InterventionInternet-based CBT-I delivered over 6 weekly lesson modules with assigned homework activities.Main outcomes and measuresThe prespecified primary outcome measure was change in ISI score over time. Prespecified secondary outcome measures included self-reported measures of depression symptoms, posttraumatic stress disorder (PTSD) symptoms, sleep quality, migraine impact, and fatigue.ResultsOf 204 people screened, 125 were randomized 3:1 to eCBT-I vs online sleep education, and 106 completed baseline evaluations (83 men [78.3%]; mean [SD] age, 42 [12] years). Of these, 22 participants (20.8%) were Hispanic or Latino and 78 (73.6%) were White. Fifty participants completed postintervention evaluations, and 41 completed the 3-month follow-up. Baseline mean (SD) ISI scores were 19.7 (4.0) in those randomized to eCBT-I and 18.9 (5.0) in those randomized to sleep education. After intervention, mean (SD) ISI scores were 13.7 (5.6) in those randomized to eCBT-I and 16.6 (5.7) in those randomized to sleep education. The difference in the extent of reduction in ISI scores between groups was 3.5 (95% CI,-6.5 to -0.4 [P = .03]; Cohen d, -0.32 [95% CI, -0.70 to -0.04]). In the eCBT-I group, the extent of insomnia improvement correlated with the extent of depressive symptom improvement (Spearman ρ = 0.68 [P < .001]), PTSD symptoms (ρ = 0.36 [P = .04]), sleep quality (ρ = 0.54 [P = .001]), and fatigue impact (ρ = -0.58 [P < .001]) but not migraine-related disability.Conclusions and relevanceThe findings of this randomized clinical trial suggest that fully remote eCBT-I was moderately feasible and effective for self-reported insomnia and depression symptoms in military service members and veterans with a history of TBI. There is great potential benefit for eCBT-I due to low availability and cost of qualified CBT-I clinicians, although optimization of completion rates remains a challenge. Future studies may use home-based objective sleep assessments and should increase study retention.Trial registrationClinicalTrials.gov Identifier: NCT04377009.

Project description:Study objectivesTo determine if a population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia (ICBT-I) affects dispensed medications and provider encounters compared with usual care.MethodsA pragmatic hybrid study design was used to evaluate both the implementation strategy and the long-term effects of ICBT-I on health care utilization in an integrated health system. Adult members with insomnia (a diagnosis or insomnia medication dispensation) or at high risk of insomnia (a diagnosis of depression or anxiety) were randomized to receive information on either an ICBT-I program (intervention arm) or in-person classes on insomnia (usual-care arm). Outcomes included dispensed insomnia medications and provider encounters over 12 months. The effectiveness of our implementation of ICBT-I on the target population was determined by an intention-to-treat analysis and by regression models comparing those who engaged in ICBT-I with matched usual-care arm controls.ResultsA total of 136,630 participants were randomized. Six hundred thirty-eight (0.96%) accessed the ICBT-I program while 431 (0.66%) attended 1 or more usual-care insomnia classes. Dispensed insomnia medications and provider encounters were no different in the ICBT-I arm vs the usual-care arm (intention-to-treat) or among those who engaged in ICBT-I vs matched usual-care arm controls.ConclusionsSince ICBT-I program engagement was low, additional strategies to improve engagement should be explored. ICBT-I did not result in a reduction in several measures of health care utilization; nevertheless, it offers an alternative and accessible approach to managing population insomnia.Clinical trial registrationRegistry: ClinicalTrials.gov; Name: Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications; URL: https://clinicaltrials.gov/ct2/show/NCT03313466; Identifier: NCT03313466.CitationDerose SF, Rozema E, Chen A, Shen E, Hwang D, Manthena P. A population health approach to insomnia using internet-based cognitive behavioral therapy for insomnia. J Clin Sleep Med. 2021;17(8):1675-1684.

Project description:BackgroundInternet-based cognitive behavioral therapy (iCBT) is a promising new treatment method for depression and anxiety. However, it is important to determine whether its results can be replicated in routine care before its implementation on a large scale. Although many studies have demonstrated the efficacy of iCBT under controlled conditions, only a few studies have investigated its effectiveness in routine care. Furthermore, several effects of iCBT such as treatment effects in routine care are unclear.ObjectiveThis study aimed to evaluate the clinical effectiveness of iCBT for depression and anxiety in routine secondary care.Methodsn a retrospective cohort study, we analysed patients treated for depression or anxiety in a dedicated iCBT clinic in secondary care in Denmark. Patients were examined before treatment and weekly thereafter by using the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 scales for the diagnoses of depression and anxiety, respectively. Primary analyses were conducted using a linear mixed-effects model with random slope and intercept. Secondary analyses were conducted using baseline characteristics as predictors (gender, age, highest level of education, occupational status, marital status, psychotropic medication use, consumption of alcohol, and leisure drugs). Additionally, logistic regression analyses were used to predict noncompletion of treatment.ResultsA total of 203 (depression, N=60; anxiety, N=143) patients were included. Participants were mainly female (78.3% with depression and 65.7% with anxiety), with a mean age of 36.03 (SD 10.97) years (range, 19-67 years) for patients with depression and 36.80 (SD 13.55) years (range, 19-69 years) for patients with anxiety. The completion rates were 62% (37) and 40% (57) for depression and anxiety treatments, respectively. The primary analyses revealed large and significant reductions in the symptom levels of depression (beta=-6.27, SE 0.83, P<.001, d=1.0) and anxiety (beta=-3.78, SE 0.43, P<.001, d=1.1). High baseline severity of the primary disorder was associated with high treatment gains (r=-0.31 for depression; r=-0.41 for anxiety). In patients with anxiety, high baseline severity also predicted a high risk of noncompletion (odds ratio=1.08, CI=1.01-1.16, P=.03). An increase in the baseline severity of the comorbid disorder slightly increased the risk of noncompletion for both disorders (depression: odds ratio=1.03, CI=1.01-1.06, P=.02; anxiety: odds ratio=1.08, CI=1.01-1.16, P=.03).ConclusionsiCBT can be clinically effective in routine care. Since depression and anxiety are costly and debilitating disorders that are vastly undertreated, this finding is important. Additionally, iCBT may help bridge the gap between the need for treatment and its provision. Our results are comparable to the within-group results of efficacy and effectiveness studies. Our noncompletion rates are similar to those observed in psychotherapy but are higher than those reported in similar clinics. Multiple factors predicted outcome and noncompletion. However, all predictor effects were statistically weak.

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Internet-guided cognitive, behavioral and chronobiological interventions in depression-prone insomnia subtypes: protocol of a randomized controlled prevention trial.

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Internet-guided cognitive, behavioral and chronobiological interventions in depression-prone insomnia subtypes: protocol of a randomized controlled prevention trial.

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