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 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.
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 |
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
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 7.90 • n=99 Participants
|
62.2 years
STANDARD_DEVIATION 8.31 • n=107 Participants
|
63.1 years
STANDARD_DEVIATION 8.15 • n=206 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=99 Participants
|
110 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
121 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
|
Insomnia Severity Index (ISI)
|
15.9 Score on a scale
STANDARD_DEVIATION 4.25 • n=99 Participants
|
15.4 Score on a scale
STANDARD_DEVIATION 4.14 • n=107 Participants
|
15.6 Score on a scale
STANDARD_DEVIATION 4.19 • n=206 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)
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)
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)
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)
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)
9-month
|
10.8 score on a scale
Standard Deviation 4.76
|
9.12 score on a scale
Standard Deviation 4.94
|
|
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
|
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
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
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
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
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
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
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)
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
|
|
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
|
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