Trial Outcomes & Findings for Sleep Treatment Education Program-1 (STEP-1) (NCT NCT05519982)
NCT ID: NCT05519982
Last Updated: 2026-02-02
Results Overview
The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
COMPLETED
NA
70 participants
Baseline to 8 weeks
2026-02-02
Participant Flow
Participant milestones
| Measure |
STEP-1
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
|---|---|---|
|
Intervention Session and Evaluation
STARTED
|
35
|
35
|
|
Intervention Session and Evaluation
COMPLETED
|
35
|
35
|
|
Intervention Session and Evaluation
NOT COMPLETED
|
0
|
0
|
|
Required Follow-up
STARTED
|
35
|
35
|
|
Required Follow-up
COMPLETED
|
34
|
33
|
|
Required Follow-up
NOT COMPLETED
|
1
|
2
|
|
Optional Extended Follow-up
STARTED
|
33
|
32
|
|
Optional Extended Follow-up
COMPLETED
|
24
|
20
|
|
Optional Extended Follow-up
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
STEP-1
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
|---|---|---|
|
Required Follow-up
Lost to Follow-up
|
0
|
2
|
|
Required Follow-up
Withdrawal by Subject
|
1
|
0
|
|
Optional Extended Follow-up
Lost to Follow-up
|
9
|
12
|
Baseline Characteristics
Sleep Treatment Education Program-1 (STEP-1)
Baseline characteristics by cohort
| Measure |
STEP-1
n=34 Participants
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
n=33 Participants
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.9 Years
STANDARD_DEVIATION 10.7 • n=41 Participants
|
60.8 Years
STANDARD_DEVIATION 11.9 • n=1581 Participants
|
61.4 Years
STANDARD_DEVIATION 11.2 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=41 Participants
|
26 Participants
n=1581 Participants
|
49 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
18 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=41 Participants
|
31 Participants
n=1581 Participants
|
62 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=41 Participants
|
32 Participants
n=1581 Participants
|
65 Participants
n=4626 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Insomnia Severity Index
|
15.8 Units on a scale
STANDARD_DEVIATION 3.0 • n=41 Participants
|
15.5 Units on a scale
STANDARD_DEVIATION 3.8 • n=1581 Participants
|
15.8 Units on a scale
STANDARD_DEVIATION 3.3 • n=4626 Participants
|
|
Profile of Mood States - Short Form (Total Mood Disturbance)
|
9.7 Units on a scale
STANDARD_DEVIATION 14.1 • n=41 Participants
|
13.6 Units on a scale
STANDARD_DEVIATION 19.4 • n=1581 Participants
|
11.7 Units on a scale
STANDARD_DEVIATION 17.2 • n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8 weeksThe Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Outcome measures
| Measure |
STEP-1
n=34 Participants
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
n=33 Participants
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
|---|---|---|
|
Insomnia Severity Change at 8 Weeks
|
7.3 Units on a scale
Standard Deviation 4.2
|
9.5 Units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Baseline to 8 weeksThe Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Outcome measures
| Measure |
STEP-1
n=34 Participants
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
n=33 Participants
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
|---|---|---|
|
Profile of Mood States Change at 8 Weeks
|
.85 Units on a scale
Standard Deviation 11.7
|
4.2 Units on a scale
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: Baseline to 4 weeksThe Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment.
Outcome measures
| Measure |
STEP-1
n=34 Participants
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
n=33 Participants
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
|---|---|---|
|
Profile of Mood States Change at 4 Weeks
|
3.4 Units on a scale
Standard Deviation 14.9
|
6.4 Units on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: Baseline to 8 WeeksThe PROMIS Sleep Disturbance Short Form 8b (PROMIS-SD) is an 8 item scale used to assess sleep disturbances and their impact on overall sleep quality. Items include specific sleep problems (e.g., restless sleep) as well as satisfaction with sleep quality and amount of sleep. Item responses are summed to calculate a Total score, with raw scores (range 8-40) translated into t-scores (mean = 50, SD= 10). Higher PROMIS-SD Total t-scores indicate greater levels of sleep disturbance.
Outcome measures
| Measure |
STEP-1
n=34 Participants
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
n=33 Participants
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
|---|---|---|
|
Change in Sleep Quality
|
52.2 Units on a scale
Standard Deviation 4.3
|
53.1 Units on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: Administered at 8 week follow-upTotal sleep time in hours per night calculated from the Consensus Sleep Diary-Morning
Outcome measures
| Measure |
STEP-1
n=34 Participants
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
n=33 Participants
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
|---|---|---|
|
Sleep Duration
|
7.0 Time (in hours per night)
Interval 6.3 to 7.9
|
7.3 Time (in hours per night)
Interval 6.2 to 7.9
|
SECONDARY outcome
Timeframe: Baseline to 4 WeeksThe Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden.
Outcome measures
| Measure |
STEP-1
n=34 Participants
Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring
|
Relaxation (Control)
n=33 Participants
Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery
|
|---|---|---|
|
Insomnia Severity Change at 4 Weeks
|
8.6 Units on a scale
Standard Deviation 4.4
|
11.7 Units on a scale
Standard Deviation 3.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 4 weeks post-interventionStudy specific participant checklist describing ease of use, acceptability and credibility of intervention
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Completed at the 8-week post-intervention timepointBrief participant questionnaire to provide feedback about the intervention and how it could be improved.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 13 weeks post-interventionBrief participant questionnaire to provide feedback about coaching session. could be improved.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 16 weeks post-interventionAfter completing 8-week follow-up, participants will be asked if they are willing to complete one additional Insomnia Severity Scale 8 weeks later.
Outcome measures
Outcome data not reported
Adverse Events
STEP-1
Relaxation (Control)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place