Charles M. Morin - US grants

Insomnia is a widespread health problem among the elderly and has a detrimental impact on waking functions and quality of life. Previous research has shown behavioral interventions effective for treating sleep onset insomnia in young adults. However, sleep maintenance insomnia, a much more prevalent sleep disorder in the elderly, has received very little empirical attention. The proposed study is intended to evaluate the clinical efficacy of a cognitive-behavioral intervention against a wait-list control condition for treating geriatric insomnia. Thirty (30) older adults, aged 60 or older, and meeting ASDC (Association of sleep Disorders Centers) criteria for disorder of maintaining Sleep will be selected from the community. Subjects will be randomly assigned to either the treatment (n=15) or wait-list control (n=15) conditions. Those in the experimental group will receive 8 weekly 90-min. group therapy sessions. Treatment will consist of 3 components: (1) education about sleep hygiene principles; (2) stimulus control procedures aimed at regulating sleep-wake schedules and curtailing sleep-interfering behaviors; and (3) cognitive restructuring directed at altering dysfunctional thoughts about sleep processes and correcting unrealistic sleep requirement expectations. Treatment outcome will be evaluated across measures of sleep/wake parameters, daytime sleepiness, and mood. The main dependent measures will consist of the number and duration of nocturnal awakenings as measured by polysomnographic evaluations and daily sleep diaries. To socially validate treatment outcome, significant others will provide independent ratings of perceived changes in sleep patterns as well as of its impact on daytime functioning. Follow-up will be conducted three months after treatment completion. This study will further our understanding of geriatric insomnia and its treatment. With the high prevalence of insomnia in the elderly and the shortcomings associated with drug treatments, the main objective of this study is to design a comprehensive, yet cost- effective, intervention which could routinely be administered as an alternative to pharmacotherapy for the management of geriatric insomnia.

Insomnia is a widespread health problems among the elderly. Its treatment in relation to age, however, has received very little empirical attention. Controlled evaluations of psychological and pharmacological treatments have focused on young adults and on sleep onset problems while the most prevalent complaint in late life is sleep-maintenance insomnia. There has been no direct comparison of these two treatment modalities for insomnia and it is equivocal whether drug treatments in older people produce more sleep benefits than residual daytime impairments. The proposed study is intended to evaluate the clinical and comparative efficacy of cognitive- behavior therapy and pharmacotherapy for late-life insomnia in 100 older adults. A 5 (Group) X 5 (Assessment) split-plot factorial design with repeated measures on the second factor will be used. Prospective subjects will be matched on gender and insomnia severity and randomly assigned to one of the following conditions: (a) cognitive-behavior therapy; (b) pharmacotherapy (temazepam); (c) cognitive-behavior therapy plus pharmacotherapy; (d) drug-placebo; and (e) waiting-list. All treatment will last eight weeks after the initial 2-week baseline period. Treatment outcome will be evaluated across measures of sleep, mood, and neuropsychological functioning. Placebo and wait-list subjects will receive treatment after the initial 8-week experimental phase. Follow-ups will be conducted at 3, 12, and 24 months. The main research questions addressed by this study are: (a) which treatment modality or combination produces the best outcome on subjective and objective sleep parameters? (b) what is the impact of improved sleep on mood and daytime performance measures? (c) are there predictors of successful outcome within and across treatment modalities? and, (e) how does exposure to drug and nondrug interventions for insomnia impact on long-term utilization of health-related services. Despite its widespread prevalence in the aging population, insomnia remains for the most part untreated. The long-term objective of this proposal is to design a comprehensive and cost-effective treatment program which would routinely be administered for the management of late-life insomnia.

Insomnia is a widespread health problems among the elderly. Its treatment in relation to age, however, has received very little empirical attention. Controlled evaluations of psychological and pharmacological treatments have focused on young adults and on sleep onset problems while the most prevalent complaint in late life is sleep-maintenance insomnia. There has been no direct comparison of these two treatment modalities for insomnia and it is equivocal whether drug treatments in older people produce more sleep benefits than residual daytime impairments. The proposed study is intended to evaluate the clinical and comparative efficacy of cognitive- behavior therapy and pharmacotherapy for late-life insomnia in 100 older adults. A 5 (Group) X 5 (Assessment) split-plot factorial design with repeated measures on the second factor will be used. Prospective subjects will be matched on gender and insomnia severity and randomly assigned to one of the following conditions: (a) cognitive-behavior therapy; (b) pharmacotherapy (temazepam); (c) cognitive-behavior therapy plus pharmacotherapy; (d) drug-placebo; and (e) waiting-list. All treatment will last eight weeks after the initial 2-week baseline period. Treatment outcome will be evaluated across measures of sleep, mood, and neuropsychological functioning. Placebo and wait-list subjects will receive treatment after the initial 8-week experimental phase. Follow-ups will be conducted at 3, 12, and 24 months. The main research questions addressed by this study are: (a) which treatment modality or combination produces the best outcome on subjective and objective sleep parameters? (b) what is the impact of improved sleep on mood and daytime performance measures? (c) are there predictors of successful outcome within and across treatment modalities? and, (e) how does exposure to drug and nondrug interventions for insomnia impact on long-term utilization of health-related services. Despite its widespread prevalence in the aging population, insomnia remains for the most part untreated. The long-term objective of this proposal is to design a comprehensive and cost-effective treatment program which would routinely be administered for the management of late-life insomnia.

DESCRIPTION (Adapted from applicant's abstract): Insomnia is a prevalent health problem in late life and its treatment is predominantly pharmacological in nature. Between 10 percent to 15 percent of those prescribed a hypnotic medication continue using it for more than a year, despite evidence that chronic usage is ineffective and detrimental to health and quality of life. Prolonged uses of hypnotic medications are primary older adults. Although psychological (cognitive-behavioral) interventions have been used successfully with unmedicated insomniacs, there is little empirical data on the efficacy of such nonpharmacological interventions for hypnotic-dependent insomnia. The proposed study is designed to evaluate the efficacy of cognitive-behavior therapy (CBT) and supervised medication taper, alone and in combination, for benzodiazepine discontinuation among hypnotic-dependent insomniacs. A total of 75 older adults (age > 60 years) meeting criteria for hypnotic-dependent insomnia will be randomly assigned to one of three treatment conditions: (a) cognitive-behavior therapy combined with a supervised medication taper (n = 25); (b) medication taper only (n = 25); or, (c) cognitive-behavior therapy only (n = 25). All three interventions (CBT + Taper; Taper alone; CBT alone) will last 10 weeks after the initial 2-week baseline period. Follow-ups will be conducted at 3, 12, and 24 months. Treatment outcome will be assessed across measures of sleep, mood, daytime performance, and quality of life. The main research questions are: (1) which of three treatment modalities (i.e., CBT+Taper, Taper, or CBT) is most effective for benzodiazepine- discontinuation and improving sleep patterns among hypnotic-dependent insomniacs; (2) what are the short- and long-term effects of hypnotic discontinuation on sleep, daytime performance, mood, and quality of life of older insomniacs; and (3) are there predictors (e.g., insomnia chronicity, duration of hypnotic use, coping styles) of successful outcome (i.e., drug-free and/or improved sleep). The long-term objectives of this study are to further the understanding of insomnia and chronic use of benzodiazepines in late life, and to design an effective treatment program that could be implemented routinely in the clinical management of hypnotic-dependent insomnia.

DESCRIPTION (Adapted from the Applicant's Abstract): Insomnia is a prevalent health complaint which is often associated with functional impairments, reduced quality of life, and increased health-care costs. The specific aims of the proposed study are to (a) evaluate the short- and long-term effects of cognitive -behavior therapy (CBT), alone and in combination with medication, for chronic insomnia, (b) compare the efficacy of different maintenance strategies for combining drug and nondrug therapies to optimize long-term outcomes, and (c) examine the clinical impact of treatment on daytime functioning and psychological well-being. One hundred and fifty (150) adults meeting criteria for chronic insomnia will be randomly assigned to CBT or CBT plus medication. After the acute treatment phase, which will last eight weeks, patients will be entered into an extended treatment lasting six months. Of those treated with CBT alone initially, responders will be entered into an extended CBT or no treatment. Of those receiving the combined CBT plus medication (used on an as needed schedule) or CBT alone (plus medication tapering). Outcome will be evaluated across measures of sleep, clinical ratings, and several indices of daytime functioning. The measures will be administered at baseline, at the end of the acute and extended treatment phases, and at 6-, 12-, and 24-month follow-ups. The main research questions are: (a) Is CBT in conjunction with medication more effective than CBT alone for the acute treatment of insomnia? (b) When combining CBT and drug therapy, is it best to discontinue medication after the initial acute treatment or to continue using it on an intermittent (as needed) schedule in order to foster long-term maintenance of sleep improvements? and (c) What is the clinical impact of sleep improvement on daytime fatigue and performance, psychological symptoms, and quality of life? The public health significance of the proposed study is that it will provide useful information about optimal models for integrating behavioral and pharmacological therapies for the clinical management of insomnia.

[unreadable] DESCRIPTION (provided by applicant): Insomnia is a prevalent public health problem affecting large segments of the population on an occasional, recurrent, or chronic basis. Persistent insomnia is associated with significant impairments in daytime functioning, reduced quality of life, and increased health-care costs. Despite evidence that cognitive-behavior therapy (CBT) is an effective and well accepted treatment for insomnia, a significant proportion of individuals do not respond adequately to this treatment modality. Hence, there is a need to identify the active therapy components and mechanisms of change in order to develop more effective therapeutic approaches and optimize outcomes. The specific aims of the proposed study are to (a) evaluate the effects of behavioral versus cognitive therapies for nighttime sleep disturbance and associated daytime impairment, (b) investigate the mechanisms of change and, (c) examine the collateral impact of insomnia therapies on psychological symptoms and psychiatric conditions commonly comorbid with insomnia (selected anxiety disorders and depression). A sample of 186 adults with chronic insomnia will be recruited from two sites (Laval University and University of California, Berkeley). Participants will be randomly assigned to one of three groups: (a) behavior therapy (BT; n = 62), (b) cognitive therapy (CT; n = 62), or (c) cognitive-behavior therapy (CBT; n = 62). Measures of outcome (sleep/insomnia, daytime functioning) will be administered at baseline, end of treatment, and at 6- and 12-month follow up. Measures of mechanisms of change (maladaptive sleep habits and schedules, dysfunctional beliefs and attitudes, sleep-related worry, monitoring, thought suppression) will be administered at baseline, after the 4th and 8th therapy sessions, and at the end of treatment. It is expected that (1) BT and CBT will be more effective for improving sleep, relative to CT and (2) CT and CBT will be more effective for reducing daytime functional impairment, relative to BT. It is also expected that mechanisms of change will be specific to each therapeutic approach. Finally, as CT targets maintaining mechanisms shared across various psychiatric disorders, whereas BT targets mechanisms specific to insomnia, it is hypothesized that CT will be more effective than BT in reducing comorbid psychological symptoms and psychiatric disorders. The public health significance of the proposed study is that it will provide useful information to improve our understanding of insomnia and to enhance efficacy and efficiency of therapeutic approaches for a prevalent and costly health problem. The long-term objective is to contribute to the development and dissemination of evidence-based treatments for chronic insomnia and its common comorbidities. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Chronic insomnia is a prevalent disorder associated with increased health care costs, impaired functioning, and an increased risk for developing serious psychiatric disorders. Cognitive Behavioral Therapy (CBT) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported approaches for insomnia management. Unfortunately, few studies have compared CBT and BzRA medications for insomnia treatment. Previous insomnia treatment studies also have been limited by small, highly screened study samples, fixed- dose and fixed-agent pharmacotherapy strategies that do not represent usual adjustable dosing practices, relatively short follow-up intervals, and reliance on self-reported or polysomnographically (PSG) assessed sleep parameters as outcomes, rather than on insomnia remission indicators that are more relevant to clinical practice. Finally, studies have yet to test the benefits of various treatment-sequencing strategies for those who do not respond to initial their insomnia therapies. This dual-site project will address these limitations. The two study sites will enroll a total of 320 participants who meet broad criteria for chronic insomnia disorder. Participants will be evaluated with clinical assessments and PSG, then randomly assigned to first-stage therapy with CBT or zolpidem (most widely-prescribed BzRA). Centrally trained therapists will administer CBT and zolpidem according to manualized, albeit flexible, treatment algorithms. Initial outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those who fail to achieve insomnia remission with first-line therapy will be encouraged to accept random assignment to a second, 6-week, medication (zolpidem or trazodone) or behavioral (standard or tailored CBT) treatment. All participants will be re-evaluated 12 weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing their final treatment. Insomnia remission, defined categorically as a score < 8 on the Insomnia Severity Index, will serve as the primary outcome for treatment comparisons. Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Study Aims include: (1) comparing the efficacy of CBT and Zolpidem for producing sustained insomnia remission when used as first line therapies; (2) comparing the efficacy of treatment switching and augmentation strategies for those who fail to remit with first line treatments; (3) comparing the responses of those with and without psychiatric comorbities to first and second line treatments; and (4) exploring the usefulness of selected biomarkers and trait measures as predictors of treatment outcomes. Our over-arching goal is to obtain new information that contributes to the development of clinical guidelines for PI and CMI management.