Trial Outcomes & Findings for The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (NCT NCT03532282)
NCT ID: NCT03532282
Last Updated: 2024-12-19
Results Overview
The ISI is an empirically validated 7-item questionnaire, with each item rated on a 0 to 4 scale. The score is the sum of the 7 items. scores range between 0 and 28 (higher score corresponds with greater insomnia severity), with 10 as a cutoff score for identifying individuals in the community who are likely to meet criteria for insomnia disorder and 8 as a cutoff for defining remission.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
388 participants
Primary outcome timeframe
at baseline and at months 2, 4, 6, 9, & 12
Results posted on
2024-12-19
Participant Flow
388 participants signed consent. 254 were eligible and 245 were randomized to a study arm
Participant milestones
| Measure |
ONLINE ONLY (ONLN)
Online cognitive behavioral therapy for insomnia
|
STEPPED CARE (STEP)
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
124
|
|
Overall Study
Triaged Checklist YES
|
69
|
68
|
|
Overall Study
COMPLETED
|
102
|
108
|
|
Overall Study
NOT COMPLETED
|
19
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy
Baseline characteristics by cohort
| Measure |
STEP
n=124 Participants
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
|
Total
n=245 Participants
Total of all reporting groups
|
ONLN
n=121 Participants
Online cognitive behavioral therapy for insomnia
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 8.31 • n=7 Participants
|
63.1 years
STANDARD_DEVIATION 8.15 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 7.90 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
110 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
124 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
121 Participants
n=5 Participants
|
|
Insomnia Severity Index (ISI)
|
15.4 Score on a scale
STANDARD_DEVIATION 4.14 • n=7 Participants
|
15.6 Score on a scale
STANDARD_DEVIATION 4.19 • n=5 Participants
|
15.9 Score on a scale
STANDARD_DEVIATION 4.25 • n=5 Participants
|
PRIMARY outcome
Timeframe: at baseline and at months 2, 4, 6, 9, & 12Population: Intent to treat sample; values for participants with available data at the respective time point
The ISI is an empirically validated 7-item questionnaire, with each item rated on a 0 to 4 scale. The score is the sum of the 7 items. scores range between 0 and 28 (higher score corresponds with greater insomnia severity), with 10 as a cutoff score for identifying individuals in the community who are likely to meet criteria for insomnia disorder and 8 as a cutoff for defining remission.
Outcome measures
| Measure |
ONLN
n=121 Participants
Online cognitive behavioral therapy for insomnia
|
STEP
n=124 Participants
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
|
|---|---|---|
|
Insomnia Severity Index (ISI)
6-month
|
11.3 score on a scale
Standard Deviation 4.93
|
9.45 score on a scale
Standard Deviation 4.71
|
|
Insomnia Severity Index (ISI)
12-month
|
10.8 score on a scale
Standard Deviation 5.16
|
8.23 score on a scale
Standard Deviation 4.99
|
|
Insomnia Severity Index (ISI)
2-month
|
12.7 score on a scale
Standard Deviation 5.00
|
11.6 score on a scale
Standard Deviation 4.75
|
|
Insomnia Severity Index (ISI)
Baseline
|
15.9 score on a scale
Standard Deviation 4.25
|
15.4 score on a scale
Standard Deviation 4.14
|
|
Insomnia Severity Index (ISI)
4-month
|
11.6 score on a scale
Standard Deviation 4.98
|
10.0 score on a scale
Standard Deviation 4.75
|
|
Insomnia Severity Index (ISI)
9-month
|
10.8 score on a scale
Standard Deviation 4.76
|
9.12 score on a scale
Standard Deviation 4.94
|
PRIMARY outcome
Timeframe: at baseline and at months 2, 4, 6, 9, & 12Population: Intent to treat sample; values for participants with available data at the respective time point
The average number of minimal effective doses of prescription sleep medications taken; A greater number means that the person was taking number of minimal effective doses of prescription sleep medications, with a value of 0 meaning that the person is not taking any prescription sleep medication.
Outcome measures
| Measure |
ONLN
n=121 Participants
Online cognitive behavioral therapy for insomnia
|
STEP
n=124 Participants
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
|
|---|---|---|
|
Use of Prescription Sleep Medication
Baseline
|
0.372 Average number of minimal doses
Standard Deviation 0.756
|
0.333 Average number of minimal doses
Standard Deviation 0.817
|
|
Use of Prescription Sleep Medication
4-month
|
0.340 Average number of minimal doses
Standard Deviation 0.780
|
0.202 Average number of minimal doses
Standard Deviation 0.842
|
|
Use of Prescription Sleep Medication
6-month
|
0.352 Average number of minimal doses
Standard Deviation 0.752
|
0.178 Average number of minimal doses
Standard Deviation 0.638
|
|
Use of Prescription Sleep Medication
9-month
|
0.396 Average number of minimal doses
Standard Deviation 0.929
|
0.130 Average number of minimal doses
Standard Deviation 0.372
|
|
Use of Prescription Sleep Medication
2-month
|
0.357 Average number of minimal doses
Standard Deviation 0.792
|
0.271 Average number of minimal doses
Standard Deviation 0.660
|
|
Use of Prescription Sleep Medication
12-month
|
0.375 Average number of minimal doses
Standard Deviation 0.872
|
0.205 Average number of minimal doses
Standard Deviation 0.874
|
SECONDARY outcome
Timeframe: at baseline and at months 2, 4, 6, 9, & 12Population: Intent to treat sample; values for participants with available data at the respective time point
Questionnaire measuring sleep related impairment using T-scores, with a population mean of 50 and a standard deviation of 10. T-scores of 55-60 represent mild impairment; 60-70 represent moderate impairment; 70-80 represent severe impairment.
Outcome measures
| Measure |
ONLN
n=121 Participants
Online cognitive behavioral therapy for insomnia
|
STEP
n=124 Participants
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
4-month
|
53.1 T score
Standard Deviation 8.25
|
52.1 T score
Standard Deviation 8.07
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
6-month
|
53.2 T score
Standard Deviation 7.60
|
51.0 T score
Standard Deviation 7.00
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
Baseline
|
56.8 T score
Standard Deviation 7.48
|
56.8 T score
Standard Deviation 6.66
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
2-month
|
53.7 T score
Standard Deviation 7.74
|
53.4 T score
Standard Deviation 8.01
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
9-month
|
52.2 T score
Standard Deviation 8.45
|
50.5 T score
Standard Deviation 8.31
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
12-month
|
51.0 T score
Standard Deviation 8.17
|
48.2 T score
Standard Deviation 8.32
|
SECONDARY outcome
Timeframe: at baseline and at months 2, 4, 6, 9, & 12Population: Intent to treat sample; values for participants with available data at the respective time point
A validated questionnaire measuring depressive and anxiety symptom severity. The total score ranges between 0 and 12. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
Outcome measures
| Measure |
ONLN
n=121 Participants
Online cognitive behavioral therapy for insomnia
|
STEP
n=124 Participants
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
|
|---|---|---|
|
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
Baseline
|
2.21 units on a scale
Standard Deviation 2.28
|
2.46 units on a scale
Standard Deviation 2.51
|
|
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
2-month
|
2.63 units on a scale
Standard Deviation 2.13
|
2.46 units on a scale
Standard Deviation 2.51
|
|
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
9-month
|
2.29 units on a scale
Standard Deviation 2.21
|
2.01 units on a scale
Standard Deviation 1.86
|
|
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
12-month
|
2.34 units on a scale
Standard Deviation 2.28
|
1.92 units on a scale
Standard Deviation 2.12
|
|
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
4-month
|
2.64 units on a scale
Standard Deviation 2.49
|
2.59 units on a scale
Standard Deviation 2.77
|
|
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
6-month
|
2.51 units on a scale
Standard Deviation 2.15
|
2.44 units on a scale
Standard Deviation 2.23
|
Adverse Events
ONLN
Serious events: 1 serious events
Other events: 8 other events
Deaths: 1 deaths
STEP
Serious events: 1 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
ONLN
n=121 participants at risk
Online cognitive behavioral therapy for insomnia
|
STEP
n=124 participants at risk
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
0.00%
0/121 • 1 year
|
0.81%
1/124 • 1 year
|
|
Surgical and medical procedures
Surgical complications
|
0.83%
1/121 • 1 year
|
0.00%
0/124 • 1 year
|
Other adverse events
| Measure |
ONLN
n=121 participants at risk
Online cognitive behavioral therapy for insomnia
|
STEP
n=124 participants at risk
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
|
|---|---|---|
|
Psychiatric disorders
Fatigue
|
2.5%
3/121 • 1 year
|
6.5%
8/124 • 1 year
|
|
Psychiatric disorders
Sleepiness
|
4.1%
5/121 • 1 year
|
6.5%
8/124 • 1 year
|
|
Psychiatric disorders
Worsening of sleep
|
2.5%
3/121 • 1 year
|
1.6%
2/124 • 1 year
|
|
Psychiatric disorders
Stress about sleep
|
0.00%
0/121 • 1 year
|
0.81%
1/124 • 1 year
|
|
Psychiatric disorders
Discomfort due to not enough sl
|
0.83%
1/121 • 1 year
|
1.6%
2/124 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place