Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
STOP-BANG Questionnaire |
Scores range from 0-8 with higher scores associated with higher risk of experiencing sleep apnea |
Baseline only |
|
Other |
Screen for periodic limb movement disorder |
Restless Leg Syndrome Questions |
Baseline only |
|
Other |
Medication Dosage |
Collect dose, type, frequency and changes in medications |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Other |
Medication Type |
|
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Other |
Medication Use Frequency |
|
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Other |
Change in Medications |
|
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Other |
Semi-structured interview |
Assess patient perceptions of treatment |
Only at post-treatment which is 8-10 weeks after the beginning of treatment |
|
Primary |
Patient-level outcome: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance |
Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome). |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Primary |
Sheehan Disability Scale |
Assesses functional impairment on a scale from 0 to 30, where higher scores mean higher impairment |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Positive and Negative Affect Scale |
Positive affect scores can range from 10-15, with higher scores representing higher levels of positive affect. Negative affect scores can range from 10-50, with lower scores representing lower levels of negative affect |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Perceived Stress Scale |
Individual scores on the Perceived Stress Scale can range from 0-40 with higher scores indicating higher perceived stress |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Satisfaction with Life Scale |
5-item instrument designed to measure global cognitive judgements of satisfaction with one's life. Scores can range from 5-35 with higher scores indicating higher levels of satisfaction with life. |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Credibility Expectancy Questionnaire |
Measures the credibility and expectation of improvement from the treatment. Scores can range from 9- 81 with higher scores indicating higher treatment satisfaction. |
At treatment Week 2 and at post-treatment which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Means and Variability of sleep efficiency (Daily Sleep Diary) |
Daily Sleep Diary means and variability for sleep efficiency (total sleep time/time in bed X 100), Total sleep time (TST), Total wake time (TWT), bedtime, waketime. |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment |
Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome). |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Composite Sleep Health Score |
Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time). |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
British Columbia Complaints Inventory |
Assessed perceived cognitive difficulties, scale consists of 6 items. Scores can range from 0-18 with higher scores indicating higher levels of perceived cognitive difficulties |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Mutlidimensional Fatigue Inventory |
20-item scale designed to evaluate five dimensions of fatigue. Scores can range from 20-100 with higher total scores corresponding with more acute levels of fatigue |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Cognitive Failures Questionnaire |
Used to assess the frequency with which people experienced cognitive failures. Scores range from 0-100, with higher scores indicating higher levels of cognitive failures. |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Epworth Sleepiness Scale |
Used to assess daytime sleepiness. Scores can range from 0-24 with higher scores indicating higher levels of daytime sleepiness. |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Memory for Treatment |
Recall on the Patient Treatment Recall Task |
At post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Generalization Task Questionnaire |
Measures how treatment gains sustained during therapy have generalized to the participant's thinking and functioning during every day life |
Change from baseline to post-treatment, which is 8-10 weeks after the beginning of treatment |
|
Secondary |
Acceptability Intervention Measure |
Assess provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire |
Through therapy completion, an average of 8 weeks |
|
Secondary |
Intervention Appropriateness Measure |
Assesses provider perceptions of the appropriateness of the treatment intervention using a self-report questionnaire |
Through therapy completion, an average of 8 weeks |
|
Secondary |
Feasibility of Intervention Measure |
Assesses provider perceptions of the feasibility of the intervention using a self-report questionnaire |
Through therapy completion, an average of 8 weeks |
|