Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference

Yang, Min; Morin, Charles M.; Schaefer, Kendyl; Wallenstein, Gene V.

doi:10.1185/03007990903167415

Cited by 221 publications

(162 citation statements)

References 41 publications

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“…62 These findings merit future study given our previous cross-sectional work in which insomnia was associated with both self-reported and objective functional performance, including a 100-foot decrement in six-minute walk distance. 5 Consistent with previous work, 5 the HF patients were not overall excessively sleepy, a finding possibly related to high levels of sympathetic arousal associated with both insomnia and HF.…”

Section: Discussionmentioning

confidence: 96%

“…The mean decrease of more than 7 points in insomnia severity in the CBT-I group, compared with a smaller decrease in the attention-control group exceeded the 6-point criterion indicative of clinical improvement and improved daytime function. 62 The mean ISI score at follow-up indicated that the typical patient experienced remission of insomnia. In the CBT-I group, 76% improved across one or more levels of insomnia severity and no one deteriorated, while 41% of the attention-control group improved, and 10% deteriorated.…”

Section: Resultsmentioning

confidence: 99%

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Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure

Redeker

Jeon

Andrews

et al. 2015

Journal of Clinical Sleep Medicine

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Background: Chronic insomnia is common among patients with heart failure (HF) and may contribute to fatigue and poor function. However, to date there have been no randomized controlled trials focused on treatment of insomnia or daytime symptoms in this population. Objective: The purpose of this study was to examine the preliminary effi cacy, feasibility, and acceptability of a selfmanagement intervention (cognitive behavioral therapy [CBT-I]) for insomnia among patients with stable HF. Methods: We conducted a pilot randomized controlled trial (RCT) in which patients with stable Class I-III HF (n = 25/52.1% women; mean age = 59 ± 14.8 years) were randomized in groups to CBT-I (n = 29) or an attention control condition (HF self-management with sleep hygiene; n = 19). Participants completed 2 weeks of wrist actigraphy, the insomnia severity index, and measures of fatigue, depression, sleepiness, and functional performance at baseline and follow-up. We computed the size of the effects on the dependent variables and used MANOVA to evaluate the effects of CBT-I on insomnia and fatigue. Results: CBT-I was feasible and acceptable and had a statistically signifi cant effect on insomnia and fatigue, while controlling for the effects of comorbidity and age. Conclusions: CBT-I has short-term effi cacy as a treatment for chronic insomnia among patients with stable HF. Future studies are needed to address its sustained effects. Keywords: self-management, heart failure, insomnia, cognitive behavioral therapy, sleep, fatigue, depression Citation: Redeker NS, Jeon S, Andrews L, Cline J, Jacoby D, Mohsenin V. Feasibility and effi cacy of a self-management intervention for insomnia in stable heart failure. J Clin Sleep Med 2015;11(10):1109 -1119 .pii: jc-00335-14 http://dx.doi.org/10.5664/jcsm.5082 H eart failure (HF), a disabling chronic condition that affl icts over fi ve million Americans, 1 is associated with excess morbidity and mortality, comorbidity, poor daytime function, and high symptom burden. Almost 75% of HF patients report poor sleep.2,3 Insomnia, characterized by diffi culty initiating and maintaining sleep, early morning awakenings, non-restorative sleep, and daytime dysfunction, occurs in 25% to 56% of HF patients, 2-5 who report higher rates than "healthy" controls 2 and the general population. Chronic insomnia contributes to incident HF and death. 6 It is distressing and associated with symptoms, such as fatigue, nocturnal dyspnea, depression, anxiety, pain, and excessive daytime sleepiness, poor quality of life, and decrements in functional performance. 3,5,[7][8][9][10][11][12][13] Health care providers frequently attribute sleep disturbance, including insomnia symptoms, to the pathophysiology (e.g., fl uid congestion) and symptoms of HF itself (e.g., nocturnal dyspnea, nocturia) or to sleep disordered breathing that occurs in about half the population.14 However, sleep disordered breathing does not consistently explain insomnia, self-reported sleep quality, or fatigue; and insomnia was closely associated with...

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Section: Discussionmentioning

confidence: 96%

Section: Resultsmentioning

confidence: 99%

Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure

Redeker

Jeon

Andrews

et al. 2015

Journal of Clinical Sleep Medicine

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“…Subjective sleep efficiency could not be calculated because time in bed was not captured on the patient diaries. In addition, we assessed: WASO by hour of night; the percentage of responders using various definitions (ISI ≥ 6 point improvement from baseline 22 ; sTSO and sTST ≥ 15% improvement from baseline, with the cutoff corresponding to the degree of change likely to exceed the mean placebo change from baseline based on historical data from similarly designed clinical trials conducted by Merck); and efficacy in subgroups defined by age, gender, race, region, baseline severity (above or below the median for the corresponding baseline values of the endpoint), cohort (Q or PQ), and, for the PQ-cohort only, by Q-cohort entry criteria (those who met Qcohort entry criteria versus those who did not).…”

Section: Efficacy Endpointsmentioning

confidence: 99%

Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

Herring

Connor

Snyder

et al. 2016

Journal of Clinical Sleep Medicine

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Study Objectives: Suvorexant is an orexin receptor antagonist approved for treating insomnia at a maximum dose of 20 mg. Phase-3 trials evaluated two age-adjusted (non-elderly/elderly) dose-regimes of 40/30 mg and 20/15 mg with the primary focus on 40/30 mg. We report here results from pooled analyses of the 20/15 mg dose-regime, which was evaluated as a secondary objective in the trials. Methods: Prespecified analysis of pooled data from two identical randomized, double-blind, placebo-controlled, parallel-group, 3-month trials in non-elderly (18-64 years) and elderly (≥ 65 years) patients with insomnia. Patients were randomized to suvorexant 20/15 mg (non-elderly/elderly), suvorexant 40/30 mg (non-elderly/elderly), or placebo; by design, fewer patients were randomized to 20/15 mg. Efficacy was assessed by self-reported and polysomnography (PSG; subset of patients) sleep maintenance and onset endpoints. Results: Suvorexant 20/15 mg (N = 493 treated) was effective compared to placebo (N = 767 treated) on patient-reported and PSG sleep maintenance and onset endpoints at Night-1 (PSG endpoints) / Week-1 (subjective endpoints), Month-1 and Month-3, except for effects on PSG sleep onset at Month-3. Suvorexant 20/15 mg was generally well tolerated, with 3% of patients discontinuing due to adverse events over 3 months vs. 5.2% on placebo. Somnolence was the most common adverse event (6.7% vs. 3.3% for placebo). There was no systematic evidence of rebound or withdrawal signs or symptoms when suvorexant was discontinued after 3 months of nightly use.

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“…41 The ISI is a 7-item self-report questionnaire, which has been validated for detecting the caseness of insomnia disorder, quantifying severity, and assessing treatment response. 39,40 Participants completed 2 separate versions of the ISI: one referencing the period when they were untreated, and the other targeting the period when they were on BzRAs for their insomnia. The latter began with the following prompt: "Please rate the severity of your insomnia symptoms while taking [endorsed BzRA]".…”

Section: Insomniamentioning

confidence: 99%

“…As an insomnia disorder diagnosis is symptom based, patient-reported outcomes offer the most valid metric for gauging treatment effectiveness and were hence the primary endpoints in this study. Treatment "response" was determined per empirically validated criteria for the MID in symptomatology, 39 and remission was operationalized as a reduction in symptoms to subclinical levels. 40 …”

Section: Introductionmentioning

confidence: 99%

Effectiveness of Benzodiazepine Receptor Agonists in the Treatment of Insomnia: An Examination of Response and Remission Rates

Pillai

Roth

Roehrs

et al. 2016

Sleep

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Study objectives:To examine the real-world effectiveness of benzodiazepine receptor agonists (BzRAs) by quantifying response and remission rates in a clinical sample receiving chronic BzRA treatment for insomnia. Methods: Participants were outpatients (N = 193; 72% female; 55.2 ± 11.1 year) who had an insomnia diagnosis per medical records, and who were taking a therapeutic dose of BzRA for their insomnia. Endpoints were nocturnal sleep disturbance and Insomnia Severity Index (ISI) scores. A reduction meeting the criterion for the minimally important difference in ISI scores (change ≥ 6) constituted "response"; "remission" was inferred when symptoms fell below the clinical cutoff (ISI < 11). Results: Most participants (71%) used BzRAs at least 5 nights per week. Mean ISI scores were significantly lower (t = 22.31; p < .01) while on BzRAs than when untreated, but remained in the clinical range (mean = 11.0; standard deviation = 5.7). Although 76.7% responded to treatment, only 47.7% remitted. The majority (68.9%) of participants had a sleep-onset latency > 30 minutes and/or wake-time after sleep onset > 60 minutes while on BzRAs. After controlling for gender and insomnia severity when untreated, odds of insomnia persistence despite BzRA use were 2 times higher in patients with comorbid medical [odds ratio (OR) = 2.39; 95% confidence interval (CI) = 1.20% to 4.77%; p < .05] and psychiatric disorders (OR = 2.24; 95% CI = 1.21% to 4.13%; p < .05). Conclusions: This is the first study to distinguish between response and remission in insomnia patients taking BzRAs. Findings suggest that while many insomnia patients respond to chronic BzRA treatment, most do not remit. Remission rates are particularly low for comorbid insomnia, the most prevalent phenotype of the disorder.

show abstract

Interpreting score differences in the Insomnia Severity Index: using health-related outcomes to define the minimally important difference

Cited by 221 publications

References 41 publications

Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure

Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure

Suvorexant in Patients with Insomnia: Pooled Analyses of Three-Month Data from Phase-3 Randomized Controlled Clinical Trials

Effectiveness of Benzodiazepine Receptor Agonists in the Treatment of Insomnia: An Examination of Response and Remission Rates

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