The effect of cognitive behavioral therapy for insomnia on sleep and glycemic outcomes in people with type 2 diabetes: A randomized controlled trial.

STUDY OBJECTIVES: Investigate whether aiding sleep by online cognitive behavioral therapy for insomnia (CBT-I) can improve glycemic and metabolic control, mood, quality of life (QoL) and insomnia symptoms in people with type 2 diabetes and assess the mediating role of lifestyle factors. METHODS: Adults with type 2 diabetes and insomnia symptoms were randomly assigned to CBT-I or care as usual. At baseline, three and six months we assessed HbA1c as primary outcome and glycemic control, metabolic outcomes, sleep, mood and QoL as secondary outcomes. Mixed models were used to determine within-person and between-persons differences in outcomes and mediation analysis for lifestyle factors. RESULTS: We randomized 29 participants to CBT-I and 28 to care as usual. Intention-to-treat analysis showed no significant differences in glycemic control, metabolic outcomes, anger, distress or QoL, but showed a significantly larger decrease in insomnia (-1.37(2.65: 0.09)) and depressive symptoms (-0.92(-1.77: 0.06)) and increase in BMI (0.29 kg/m2(0.00:0.57)) in the intervention compared to the control group. Only half of the intervention participants completed the CBT-I. Per protocol analysis showed a not statistically significant decrease in HbA1c (-2.10 mmol/l(-4.83:0.63)) and glucose (-0.39 mmol/l(-1.19:0.42)), metabolic outcomes and increase in QoL. Furthermore, the intervention group showed a significant decrease in insomnia (-2.22(-3.65: 0.78)) and depressive symptoms (-1.18(-2.17: 0.19)) compared to the control group. Lifestyle factors partially mediated the effect of the intervention. CONCLUSIONS: CBT-I might improve insomnia symptoms and mood, and perhaps improves glycemic control, albeit not significant, in people with type 2 diabetes and insomnia symptoms, compared to care as usual.

Treating Insomnia with High Risk of Depression Using Therapist-Guided Digital Cognitive, Behavioral, and Circadian Rhythm Support Interventions to Prevent Worsening of Depressive Symptoms: A Randomized Controlled Trial.

INTRODUCTION: The global disease burden of major depressive disorder urgently requires prevention in high-risk individuals, such as recently discovered insomnia subtypes. Previous studies targeting insomnia with fully automated eHealth interventions to prevent depression are inconclusive: dropout was high and likely biased, and depressive symptoms in untreated participants on average improved rather than worsened. OBJECTIVE: This randomized controlled trial aimed to efficiently prevent the worsening of depressive symptoms by selecting insomnia subtypes at high risk of depression for internet-based circadian rhythm support (CRS), cognitive behavioral therapy for insomnia (CBT-I), or their combination (CBT-I+CRS), with online therapist guidance to promote adherence. METHODS: Participants with an insomnia disorder subtype conveying an increased risk of depression (n = 132) were randomized to no treatment (NT), CRS, CBT-I, or CBT-I+CRS. The Inventory of Depressive Symptomatology - Self Report (IDS-SR) was self-administered at baseline and at four follow-ups spanning 1 year. RESULTS: Without treatment, depressive symptoms indeed worsened (d = 0.28, p = 0.041) in high-risk insomnia, but not in a reference group with low-risk insomnia. Therapist-guided CBT-I and CBT-I+CRS reduced IDS-SR ratings across all follow-up assessments (respectively, d = -0.80, p = 0.001; d = -0.95, p < 0.001). Only CBT-I+CRS reduced the 1-year incidence of clinically meaningful worsening (p = 0.002). Dropout during therapist-guided interventions was very low (8%) compared to previous automated interventions (57-62%). CONCLUSIONS: The findings tentatively suggest that the efficiency of population-wide preventive strategies could benefit from the possibility to select insomnia subtypes at high risk of developing depression for therapist-guided digital CBT-I+CRS. This treatment may provide effective long-term prevention of worsening of depressive symptoms. TRIAL REGISTRATION: the Netherlands Trial Register (NL7359).

Cost-effectiveness of Guided Internet-Delivered Cognitive Behavioral Therapy in Comparison with Care-as-Usual for Patients with Insomnia in General Practice.

STUDY OBJECTIVES: Clinical guidelines recommend cognitive-behavioral therapy for insomnia (CBT-I) as first-line treatment. However, provision of CBT-I is limited due to insufficient time and expertise. Internet-delivered CBT-I might bridge this gap. This study aimed to estimate the cost-effectiveness of guided, internet-delivered CBT-I (i-Sleep) compared to care-as-usual for insomnia patients in general practice over 26 weeks from a societal perspective. METHODS: Primary outcomes were the Insomnia Severity Index (ISI, continuous score and clinically relevant response), and Quality-Adjusted Life Years (QALYs). Societal costs were assessed at baseline, and at 8 and 26 weeks. Missing data were imputed using multiple imputation. Statistical uncertainty around cost and effect differences was estimated using bootstrapping, and presented in cost-effectiveness planes and acceptability curves. RESULTS: The difference in societal costs between i-Sleep and care-as-usual was not statistically significant (-€318; 95% CI -1282 to 645). Cost-effectiveness analyses revealed a 95% probability of i-Sleep being cost-effective compared to care-as-usual at ceiling ratios of €450/extra point of improvement in ISI score and €7,000/additional response to treatment, respectively. Cost-utility analysis showed a 67% probability of cost-effectiveness for i-Sleep compared to care-as-usual at a ceiling ratio of 20,000 €/QALY gained. CONCLUSIONS: The internet-delivered intervention may be considered cost-effective for insomnia severity in comparison with care-as-usual from the societal perspective. However, the improvement in insomnia severity symptoms did not result in similar improvements in QALYs.

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia.

Chronic insomnia is preferably treated with cognitive behavioral therapy for insomnia (CBTI), but many insomnia sufferers receive medication instead, likely because of high costs, lack of knowledge about optimal insomnia treatment among physicians, and lack of CBTI-trained professionals in mental health care. A possible solution is to offer CBTI through the Internet: I-CBTI. I-CBTI is generally acceptable to patients and greatly improves insomnia symptoms. We review the state of knowledge around I-CBTI and its effects. CBTI's effectiveness is influenced by treatment characteristics and patient-specific factors. We review potential factors that help identify which patients may benefit from I-CBTI.

Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy for Insomnia in General Practice: Results from a Pragmatic Randomized Clinical Trial.

INTRODUCTION: Guidelines recommend cognitive behavioral therapy for insomnia (CBT-I) as the first line of treatment for insomnia in general practice, but CBT-I is rarely available. Nurse-guided Internet-delivered CBT-I might be a solution to improve access to care. OBJECTIVE: We aimed to determine the effectiveness of nurse-guided Internet-delivered CBT-I (I-CBT-I) on insomnia severity experienced by patients in general practice. METHODS: Nurse-guided I-CBT-I ("i-Sleep") was compared to care-as-usual (and I-CBT-I after 6 months) in 15 participating general practices among 134 patients (≥18 years old) with clinical insomnia symptoms. Assessments took place at 8, 26 and 52 weeks. Primary outcome was self-reported insomnia severity (Insomnia Severity Index) at 8 weeks. Secondary outcomes were sleep diary indices, depression and anxiety symptoms (Hospital Anxiety and Depression Scale), fatigue, daytime consequences of insomnia, sleep medication and adverse events. RESULTS: Two thirds of the 69 intervention patients (n = 47; 68%) completed the whole intervention. At the posttest examination, there were large significant effects for insomnia severity (Cohen's d =1.66), several sleep diary variables (wake after sleep onset, number of awakenings, terminal wakefulness, sleep efficiency, sleep quality) and depression. At 26 weeks there were still significant effects on insomnia severity (d = 1.02) and on total sleep time and sleep efficiency. No significant effects were observed for anxiety, fatigue, daily functioning or sleep medication. No adverse events were reported. CONCLUSIONS: Nurse-guided I-CBT-I effectively reduces insomnia severity among general practice patients. I-CBT-I enables general practitioners to offer effective insomnia care in accordance with the clinical guidelines.

Cognitive behavioral therapy for insomnia: A meta-analysis of long-term effects in controlled studies.

Cognitive behavioral therapy for insomnia (CBT-I) is a treatment with moderate to large effects. These effects are believed to be sustained long-term, but no systematic meta-analyses of recent evidence exist. In this present meta-analysis, we investigate long-term effects in 30 randomized controlled trials (RCTs) comparing CBT-I to non-active control groups. The primary analyses (n = 29 after excluding one study which was an outlier) showed that CBT-I is effective at 3-, 6- and 12-mo compared to non-active controls: Hedges g for Insomnia severity index: 0.64 (3 m), 0.40 (6 m) and 0.25 (12 m); sleep onset latency: 0.38 (3 m), 0.29 (6 m) and 0.40 (12 m); sleep efficiency: 0.51 (3 m), 0.32 (6 m) and 0.35 (12 m). We demonstrate that although effects decline over time, CBT-I produces clinically significant effects that last up to a year after therapy.

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia.

Chronic insomnia is preferably treated with cognitive behavioral therapy for insomnia (CBTI), but many insomnia sufferers receive medication instead, likely because of high costs, lack of knowledge about optimal insomnia treatment among physicians, and lack of CBTI-trained professionals in mental health care. A possible solution is to offer CBTI through the Internet: I-CBTI. I-CBTI is generally acceptable to patients and greatly improves insomnia symptoms. We review the state of knowledge around I-CBTI and its effects. CBTI's effectiveness is influenced by treatment characteristics and patient-specific factors. We review potential factors that help identify which patients may benefit from I-CBTI.

Digital Delivery of Cognitive Behavioral Therapy for Insomnia.

PURPOSE OF REVIEW: Digital cognitive behavioral therapy (dCBT) has been available for over a decade. We reviewed the evidence that accumulated over the past 5 years and discuss the implications for introducing dCBT into standard healthcare. RECENT FINDINGS: Studies have consistently supported the use of dCBT to treat insomnia. Evidence is now demonstrating large short-term effects and smaller long-term effects up to 1.5 years after treatment across populations with various co-occurring health problems. The effects also extend into a range of psychological well-being factors. Mediators and moderators have been studied to understand mechanisms and create new opportunities to enhance effectiveness and reduce dropout. Incorporating personalized guidance in dCBT may further enhance effectiveness. The evidence for dCBT for insomnia is strong and suggests that dCBT is ready for application in standard healthcare. Further research, digital innovation, and development of effective implementation methods are required to ensure dCBT fulfills its potential.

Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis.

Insomnia is a major public health problem considering its high prevalence, impact on daily life, co-morbidity with other disorders and societal costs. Cognitive behavioral treatment for insomnia (CBTI) is currently considered to be the preferred treatment. However, no meta-analysis exists of all studies using at least one component of CBTI for insomnia, which also uses modern techniques to pool data and to analyze subgroups of patients. We included 87 randomized controlled trials, comparing 118 treatments (3724 patients) to non-treated controls (2579 patients). Overall, the interventions had significant effects on: insomnia severity index (g = 0.98), sleep efficiency (g = 0.71), Pittsburgh sleep quality index (g = 0.65), wake after sleep onset (g = 0.63) and sleep onset latency (SOL; g = 0.57), number of awakenings (g = 0.29) and sleep quality (g = 0.40). The smallest effect was on total sleep time (g = 0.16). Face-to-face treatments of at least four sessions seem to be more effective than self-help interventions or face-to-face interventions with fewer sessions. Otherwise the results seem to be quite robust (similar for patients with or without comorbid disease, younger or older patients, using or not using sleep medication). We conclude that CBTI, either its components or the full package, is effective in the treatment of insomnia.

Cost-effectiveness of i-Sleep, a guided online CBT intervention, for patients with insomnia in general practice: protocol of a pragmatic randomized controlled trial.

BACKGROUND: Insomnia is a highly prevalent disorder causing clinically significant distress and impairment. Furthermore, insomnia is associated with high societal and individual costs. Although cognitive behavioural treatment for insomnia (CBT-I) is the preferred treatment, it is not used often. Offering CBT-I in an online format may increase access. Many studies have shown that online CBT for insomnia is effective. However, these studies have all been performed in general population samples recruited through media. This protocol article presents the design of a study aimed at establishing feasibility, effectiveness and cost-effectiveness of a guided online intervention (i-Sleep) for patients suffering from insomnia that seek help from their general practitioner as compared to care-as-usual. METHODS/DESIGN: In a pragmatic randomized controlled trial, adult patients with insomnia disorder recruited through general practices are randomized to a 5-session guided online treatment, which is called "i-Sleep", or to care-as-usual. Patients in the care-as-usual condition will be offered i-Sleep 6 months after inclusion. An ancillary clinician, known as the psychological well-being practitioner who works in the GP practice (PWP; in Dutch: POH-GGZ), will offer online support after every session. Our aim is to recruit one hundred and sixty patients. Questionnaires, a sleep diary and wrist actigraphy will be administered at baseline, post intervention (at 8 weeks), and at 6 months and 12 months follow-up. Effectiveness will be established using insomnia severity as the main outcome. Cost-effectiveness and cost-utility (using costs per quality adjusted life year (QALY) as outcome) will be conducted from a societal perspective. Secondary measures are: sleep diary, daytime consequences, fatigue, work and social adjustment, anxiety, alcohol use, depression and quality of life. DISCUSSION: The results of this trial will help establish whether online CBT-I is (cost-) effective and feasible in general practice as compared to care-as-usual. If it is, then quality of care might be increased because implementation of i-Sleep makes it easier to adhere to insomnia guidelines. Strengths and limitations are discussed. TRIAL REGISTRATION: Netherlands Trial register NTR 5202 (registered April 17(st) 2015).