Insomnia
Conditions
Keywords
cognitive behavior therapy, insomnia
Brief summary
Sleep problems are common among older people, and research suggests that insomnia has negative effects on health and quality of life in older adults. Prior research suggests that insomnia symptoms are even more common among veterans compared to the general population. In addition, people with sleep problems also often have depression and other problems that seem to decrease their quality of life. In this study, we tested two methods of providing behavioral sleep interventions for treating insomnia in older veterans. The long-term objective of this work was to identify ways to improve access to these types of behavioral sleep interventions for older veterans, in order to improve their well-being and quality of life. This project was conducted in outpatient clinics of the VA Greater Los Angeles Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia were identified by a postal survey. Enrolled veterans with insomnia (N=150 total, 50 per group) were randomized to one of three groups: Individual-Cognitive Behavioral Therapy for Insomnia (Individual-CBTI), Group-CBTI or a group-based Sleep Education Control Condition (Control). Measures of sleep, depression and quality of life were performed at baseline (enrollment in the study), after the treatment was completed, and at 6-months and 12-months follow-up after randomization. Main outcome measures included sleep/wake patterns (sleep questionnaires, sleep diary and wrist actigraphy, which is an objective estimate of sleep and wakefulness). We hypothesized that the intervention would improve sleep at six months follow-up. We also expected that these improvements would be maintained at 12-months follow-up.
Detailed description
Sleep disturbance is common among older people due to age-related changes in sleep, in addition to health conditions, psychosocial issues, medication effects and a variety of other factors that impact sleep. The evidence that insomnia has negative effects on health and quality of life in older adults is convincing. Prior research has demonstrated that insomnia symptoms are even more common among veterans compared to the general population. Our own work has demonstrated that sleep problems are associated with depressive symptoms and other impairments in quality of life in older people, and that nonpharmacological and behavioral interventions can improve sleep in a variety of settings. Objectives: We tested two methods of providing behavioral sleep interventions for treating insomnia in older veterans. The long-term objective of this work was to identify ways to improve access to behavioral sleep interventions for older veterans, in order to improve their well-being and quality of life. Methods: This project was conducted in outpatient clinics of the VA Greater Los Angeles Healthcare System. Community-dwelling older veterans (aged 60 years and older) with insomnia were identified by a postal survey. Enrolled veterans with insomnia (N=150, 50 per group) were randomized to one of three groups:Individual Cognitive Behavioral Therapy for Insomnia (Individual-CBTI), Group-CBTI, or group-based Sleep Education Control Condition (Control). The intervention involved a manual-based behavioral sleep intervention provided by a non-clinician sleep coach. Baseline data included subjective and objective measures of sleep, and structured assessments of depression and quality of life. Post-treatment assessments was performed after completion of the 6-week intervention, and follow-up assessments were performed at 6-months and 12-months after randomization. Main outcome measures were: sleep measures obtained from sleep diaries (i.e., sleep onset latency, wake after sleep onset, total wake time, sleep efficiency). Sleep efficiency was also obtained from wrist actigraphy. Subjective sleep quality was measured by the Pittsburgh Sleep Quality Index. Insomnia severity, depression and self-reported quality of life were measured as secondary outcomes. Data were analyzed for all randomized participants (n=159) in an intention to treat analysis. The study was not designed to compare differences in primary outcomes between individual and group CBT-I. Subjects who received individual and group CBT-I were pooled to form the intervention group. We hypothesized that the intervention would improve sleep (both objectively and subjectively) at six-month follow-up and improvements would be maintained at 12-month follow-up.
Interventions
Manual-based CBT-I provided in 5 individual or group sessions by a non-clinician sleep coach.
Manual-based non-directive sleep education provided in 5 group sessions by a health educator.
Sponsors
Study design
Eligibility
Inclusion criteria
Report symptoms that meet diagnostic criteria for insomnia and are: * age \>=60, * community-dwelling, * live within a 30-mile radius of VA Greater Los Angeles Healthcare System (GLAHS), and * have transportation to VA GLAHS to attend the intervention/control programs.
Exclusion criteria
* Significant cognitive impairment (MMSE score \<24) and have evidence of sleep apnea (by questionnaire and/or sleep monitoring).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Onset Latency | Six months after randomization | Mean time to fall asleep based on 7-day sleep diary. |
| Wake After Sleep Onset | Six months after randomization | Mean total minutes awake during nighttime awakenings based on 7-day sleep diary. |
| Total Wake Time | Six months after randomization | Mean total minutes awake from bedtime to rise time based on 7-day sleep diary. |
| Sleep Efficiency From Sleep Diary | Six months after randomization | Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary. |
| Sleep Efficiency From Wrist Actigraphy | Six months from randomization | Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy. |
| Pittsburgh Sleep Quality Index (PSQI) | Six months after randomization | The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 - 21. A total score \> 8 indicates poor sleep quality. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from among community-dwelling older veterans who responded to an insomnia screening postal survey and who met diagnostic criteria for insomnia. The recruitment period was from May 2010 to February 2012. A total of 519 subjects were enrolled.
Pre-assignment details
Following enrollment, subjects with a Mini-Mental State Exam (MMSE) score \< 24 or an apnea hypopnea index (AHI) \> 20 were ineligible for randomization. Subjects with unstable medical or psychological conditions were also excluded. Results are presented for the 159 subjects who were randomized (106 intervention and 53 control).
Participants by arm
| Arm | Count |
|---|---|
| CBT-I Manual-based cognitive behavioral therapy for insomnia (CBT-I) provided in 5 individual or group sessions by a health educator. | 106 |
| Control Non-directive sleep education provided in 5 group sessions by a health educator. | 53 |
| Total | 159 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Refused follow-up | 9 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Total | CBT-I | Control |
|---|---|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 7.7 | 71.2 years STANDARD_DEVIATION 7.9 | 72.4 years STANDARD_DEVIATION 7.3 |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 1 Participants |
| Sex: Female, Male Male | 153 Participants | 101 Participants | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 106 | 0 / 53 |
| other Total, other adverse events | 0 / 106 | 0 / 53 |
| serious Total, serious adverse events | 0 / 106 | 0 / 53 |
Outcome results
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index assesses subjective sleep quality and sleep disturbances The PSQI ia an 18-item questionnaire with a total score range from 0 - 21. A total score \> 8 indicates poor sleep quality.
Time frame: Six months after randomization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CBT-I | Pittsburgh Sleep Quality Index (PSQI) | 6.0 units on a scale |
| Control | Pittsburgh Sleep Quality Index (PSQI) | 7.2 units on a scale |
Sleep Efficiency From Sleep Diary
Sleep efficiency (mean percent time asleep while in bed) based on 7-day sleep diary.
Time frame: Six months after randomization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CBT-I | Sleep Efficiency From Sleep Diary | 82.7 percentage of time asleep while in bed |
| Control | Sleep Efficiency From Sleep Diary | 83.1 percentage of time asleep while in bed |
Sleep Efficiency From Wrist Actigraphy
Sleep efficiency (mean percent time asleep while in bed) based on 7 days of wrist actigraphy.
Time frame: Six months from randomization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CBT-I | Sleep Efficiency From Wrist Actigraphy | 82.7 percentage of time asleep while in bed |
| Control | Sleep Efficiency From Wrist Actigraphy | 83.1 percentage of time asleep while in bed |
Sleep Onset Latency
Mean time to fall asleep based on 7-day sleep diary.
Time frame: Six months after randomization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CBT-I | Sleep Onset Latency | 21.3 Minutes |
| Control | Sleep Onset Latency | 31.3 Minutes |
Total Wake Time
Mean total minutes awake from bedtime to rise time based on 7-day sleep diary.
Time frame: Six months after randomization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CBT-I | Total Wake Time | 73.4 Minutes |
| Control | Total Wake Time | 108 Minutes |
Wake After Sleep Onset
Mean total minutes awake during nighttime awakenings based on 7-day sleep diary.
Time frame: Six months after randomization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CBT-I | Wake After Sleep Onset | 30.3 Minutes |
| Control | Wake After Sleep Onset | 42.8 Minutes |