Insomnia
Conditions
Brief summary
This project aims to compare the effectiveness and implementation potential of two primary care friendly approaches to delivering an effective non-pharmacological intervention - cognitive behavioral therapy - for insomnia to middle aged and older adults.
Detailed description
All participants will receive cognitive behavioral therapy for insomnia, either through an online program or through visit with a therapist specializing in behavioral sleep medicine, and is some cases both. Participants will be randomized with equal probability to an ONLINE ONLY treatment arm or to a STEPPED CARE arm, whereby they will be assigned to on line or therapist-led treatment, based on their clinical presentation; but those assigned to this arm who start treatment with an online program and do not have sufficient response after 2 months will be switched over to a therapist-led treatment.
Interventions
BEHAVIORALONLINE ONLY
Access to an online cognitive behavioral therapy for insomnia
BEHAVIORALSTEPPED CARE
A two step treatment that starts with either an online or therapist led cognitive behavioral therapy for insomnia, depending on a decision algorithm (checklist). Those with insufficient progress to the online treatment after 8 weeks are switched to a therapist-led treatment
Sponsors
Stanford University
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* insomnia disorder
Exclusion criteria
* Unable to be consented in English without an interpreter * In poor physical or mental that limits capacity to participate in study treatment (e.g., Mini-Mental State Examination score \< 25) * Unable to use the internet * Study physician determines participation is not medically advised for any reason
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | at baseline and at months 2, 4, 6, 9, & 12 | 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. |
| Use of Prescription Sleep Medication | at baseline and at months 2, 4, 6, 9, & 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | at baseline and at months 2, 4, 6, 9, & 12 | 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. |
| PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | at baseline and at months 2, 4, 6, 9, & 12 | 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). |
Countries
United States
Participant flow
Pre-assignment details
388 participants signed consent. 254 were eligible and 245 were randomized to a study arm
Participants by arm
| Arm | Count |
|---|---|
| ONLN Online cognitive behavioral therapy for insomnia | 121 |
| STEP Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both | 124 |
| Total | 245 |
Baseline characteristics
| Characteristic | ONLN | STEP | Total |
|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 7.9 | 62.2 years STANDARD_DEVIATION 8.31 | 63.1 years STANDARD_DEVIATION 8.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 12 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 110 Participants | 218 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants | 2 Participants | 8 Participants |
| Insomnia Severity Index (ISI) | 15.9 Score on a scale STANDARD_DEVIATION 4.25 | 15.4 Score on a scale STANDARD_DEVIATION 4.14 | 15.6 Score on a scale STANDARD_DEVIATION 4.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 21 Participants | 22 Participants | 43 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 2 Participants | 10 Participants |
| Race (NIH/OMB) White | 88 Participants | 89 Participants | 177 Participants |
| Region of Enrollment United States | 121 Participants | 124 Participants | 245 Participants |
| Sex: Female, Male Female | 92 Participants | 90 Participants | 182 Participants |
| Sex: Female, Male Male | 29 Participants | 34 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 121 | 1 / 124 |
| other Total, other adverse events | 8 / 121 | 9 / 124 |
| serious Total, serious adverse events | 1 / 121 | 1 / 124 |
Outcome results
Primary
Insomnia Severity Index (ISI)
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.
Time frame: at baseline and at months 2, 4, 6, 9, & 12
Population: Intent to treat sample; values for participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONLN | Insomnia Severity Index (ISI) | Baseline | 15.9 score on a scale | Standard Deviation 4.25 |
| ONLN | Insomnia Severity Index (ISI) | 2-month | 12.7 score on a scale | Standard Deviation 5 |
| ONLN | Insomnia Severity Index (ISI) | 4-month | 11.6 score on a scale | Standard Deviation 4.98 |
| ONLN | Insomnia Severity Index (ISI) | 6-month | 11.3 score on a scale | Standard Deviation 4.93 |
| ONLN | Insomnia Severity Index (ISI) | 9-month | 10.8 score on a scale | Standard Deviation 4.76 |
| ONLN | Insomnia Severity Index (ISI) | 12-month | 10.8 score on a scale | Standard Deviation 5.16 |
| STEP | Insomnia Severity Index (ISI) | 9-month | 9.12 score on a scale | Standard Deviation 4.94 |
| STEP | Insomnia Severity Index (ISI) | Baseline | 15.4 score on a scale | Standard Deviation 4.14 |
| STEP | Insomnia Severity Index (ISI) | 6-month | 9.45 score on a scale | Standard Deviation 4.71 |
| STEP | Insomnia Severity Index (ISI) | 2-month | 11.6 score on a scale | Standard Deviation 4.75 |
| STEP | Insomnia Severity Index (ISI) | 12-month | 8.23 score on a scale | Standard Deviation 4.99 |
| STEP | Insomnia Severity Index (ISI) | 4-month | 10.0 score on a scale | Standard Deviation 4.75 |
p-value: 0.001Mixed Models Analysis
Primary
Use of Prescription Sleep Medication
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.
Time frame: at baseline and at months 2, 4, 6, 9, & 12
Population: Intent to treat sample; values for participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONLN | Use of Prescription Sleep Medication | Baseline | 0.372 Average number of minimal doses | Standard Deviation 0.756 |
| ONLN | Use of Prescription Sleep Medication | 2-month | 0.357 Average number of minimal doses | Standard Deviation 0.792 |
| ONLN | Use of Prescription Sleep Medication | 4-month | 0.340 Average number of minimal doses | Standard Deviation 0.78 |
| ONLN | Use of Prescription Sleep Medication | 6-month | 0.352 Average number of minimal doses | Standard Deviation 0.752 |
| ONLN | Use of Prescription Sleep Medication | 9-month | 0.396 Average number of minimal doses | Standard Deviation 0.929 |
| ONLN | Use of Prescription Sleep Medication | 12-month | 0.375 Average number of minimal doses | Standard Deviation 0.872 |
| STEP | Use of Prescription Sleep Medication | 9-month | 0.130 Average number of minimal doses | Standard Deviation 0.372 |
| STEP | Use of Prescription Sleep Medication | Baseline | 0.333 Average number of minimal doses | Standard Deviation 0.817 |
| STEP | Use of Prescription Sleep Medication | 6-month | 0.178 Average number of minimal doses | Standard Deviation 0.638 |
| STEP | Use of Prescription Sleep Medication | 2-month | 0.271 Average number of minimal doses | Standard Deviation 0.66 |
| STEP | Use of Prescription Sleep Medication | 12-month | 0.205 Average number of minimal doses | Standard Deviation 0.874 |
| STEP | Use of Prescription Sleep Medication | 4-month | 0.202 Average number of minimal doses | Standard Deviation 0.842 |
p-value: 0.01Mixed Models Analysis
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
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.
Time frame: at baseline and at months 2, 4, 6, 9, & 12
Population: Intent to treat sample; values for participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONLN | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 2-month | 53.7 T score | Standard Deviation 7.74 |
| ONLN | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 6-month | 53.2 T score | Standard Deviation 7.6 |
| ONLN | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | Baseline | 56.8 T score | Standard Deviation 7.48 |
| ONLN | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 9-month | 52.2 T score | Standard Deviation 8.45 |
| ONLN | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 4-month | 53.1 T score | Standard Deviation 8.25 |
| ONLN | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 12-month | 51.0 T score | Standard Deviation 8.17 |
| STEP | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 4-month | 52.1 T score | Standard Deviation 8.07 |
| STEP | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | Baseline | 56.8 T score | Standard Deviation 6.66 |
| STEP | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 2-month | 53.4 T score | Standard Deviation 8.01 |
| STEP | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 12-month | 48.2 T score | Standard Deviation 8.32 |
| STEP | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 6-month | 51.0 T score | Standard Deviation 7 |
| STEP | Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire | 9-month | 50.5 T score | Standard Deviation 8.31 |
p-value: 0.0006Mixed Models Analysis
Secondary
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
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).
Time frame: at baseline and at months 2, 4, 6, 9, & 12
Population: Intent to treat sample; values for participants with available data at the respective time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ONLN | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | Baseline | 2.21 units on a scale | Standard Deviation 2.28 |
| ONLN | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 2-month | 2.63 units on a scale | Standard Deviation 2.13 |
| ONLN | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 4-month | 2.64 units on a scale | Standard Deviation 2.49 |
| ONLN | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 6-month | 2.51 units on a scale | Standard Deviation 2.15 |
| ONLN | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 9-month | 2.29 units on a scale | Standard Deviation 2.21 |
| ONLN | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 12-month | 2.34 units on a scale | Standard Deviation 2.28 |
| STEP | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 9-month | 2.01 units on a scale | Standard Deviation 1.86 |
| STEP | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | Baseline | 2.46 units on a scale | Standard Deviation 2.51 |
| STEP | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 6-month | 2.44 units on a scale | Standard Deviation 2.23 |
| STEP | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 2-month | 2.46 units on a scale | Standard Deviation 2.51 |
| STEP | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 12-month | 1.92 units on a scale | Standard Deviation 2.12 |
| STEP | PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) | 4-month | 2.59 units on a scale | Standard Deviation 2.77 |
p-value: 0.05Mixed Models Analysis