Insomnia Disorder
Conditions
Keywords
sleep-wake patterns, poor sleep
Brief summary
To finalize daytime intervention components for a comprehensive sleep-wake intervention for frail older adults and explore feasibility and acceptability using a pilot trial.
Detailed description
An enhanced intervention addressing both nighttime and daytime activities will be developed based on prior evidence and further informed by data. A successive cohort design will be utilized to evaluate and refine key intervention components and gather feedback on older adults' experiences.
Interventions
BEHAVIORALeducation and coaching on developing healthy nighttime sleep and daytime activity behaviors
The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors.
Sponsors
National Institute on Aging (NIA)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
All participants enrolled in the pilot trial will receive the intervention, all activities will be unblinded. Older adults utilizing outpatient primary care clinics belonging Atrium Wake Forest Baptist Health. All activities will take place within a clinical setting. Participants will be asked to monitor their sleep-activity behaviors while at home.
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 65 or over * One or more outpatient primary care visits to Wake Forest Baptist Health in the prior 12 months * Meets diagnostic criteria for Insomnia Disorder * Less than 30 minutes of daily activity or less than 150 minutes total weekly activity for one month or longer, as reported on brief telephone screener * Able to ambulate safely (with or without an assistive device) * Able to follow study directions * Able to communicate and follow study instructions * English speaking
Exclusion criteria
* Untreated organic sleep disorder (e.g., central or obstructive sleep apnea, restless leg syndrome) * Serious or unstable medical or psychiatric condition that would prevent participation in a behavioral intervention (e.g., terminal illness, uncontrolled psychiatric disorder, substance abuse disorder) * Lack of decision-making capacity, as documented in medical record * Referred to institutional care and/or currently residing in a nursing home or other residential facility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Efficiency | Month 2 | Total number of minutes asleep divided by total time in bed measure by wrist actigraph |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Scores | Month 2 | Insomnia Severity Index (ISI) is a 7-item validated, self-report questionnaire used to evaluate insomnia severity. Scores range from 0 - 28, higher scores indicate more severe insomnia symptom severity. |
| Total Daytime Activity | Month 2 | Daily activity (total count of steps), per wrist actigraph |
| Pittsburgh Sleep Quality Index Score | Month 2 | Pittsburgh Sleep Quality Index: Daily Disturbances score using the 3-factor scoring model, per self-reported assessment. Scores range from 0-6. Higher scores indicate more daily disturbance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors The intervention includes a four-session, in-person program delivered by a Master's-level provider. Each individual session will be approximately 30-45 minutes in length. Each session will include education and coaching on developing healthy nighttime sleep and daytime activity behaviors. | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Education | 14.9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 6 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Sleep Efficiency
Total number of minutes asleep divided by total time in bed measure by wrist actigraph
Time frame: Month 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors | Sleep Efficiency | 95.1 percent | Standard Deviation 1.7 |
Secondary
Insomnia Severity Scores
Insomnia Severity Index (ISI) is a 7-item validated, self-report questionnaire used to evaluate insomnia severity. Scores range from 0 - 28, higher scores indicate more severe insomnia symptom severity.
Time frame: Month 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors | Insomnia Severity Scores | 9.67 score on a scale | Standard Deviation 9.7 |
Secondary
Pittsburgh Sleep Quality Index Score
Pittsburgh Sleep Quality Index: Daily Disturbances score using the 3-factor scoring model, per self-reported assessment. Scores range from 0-6. Higher scores indicate more daily disturbance.
Time frame: Month 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors | Pittsburgh Sleep Quality Index Score | 1.2 score on a scale | Standard Deviation 0.4 |
Secondary
Total Daytime Activity
Daily activity (total count of steps), per wrist actigraph
Time frame: Month 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Education and Coaching on Developing Healthy Nighttime Sleep and Daytime Activity Behaviors | Total Daytime Activity | 5188 steps | Standard Deviation 2475 |