Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AG057500 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONLINE ONLY | Active Comparator | Online cognitive behavioral therapy for insomnia |
|
| STEPPED CARE | Experimental | Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONLINE ONLY | Behavioral | Access to an online cognitive behavioral therapy for insomnia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and at months 2, 4, 6, 9, & 12 |
| 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. | at baseline and at months 2, 4, 6, 9, & 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and at months 2, 4, 6, 9, & 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rachel Manber, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39115347 | Result | Manber R, Gumport NB, Tully IA, Kim JP, Kim B, Simpson N, Rosas LG, Zulman DM, Goldhaber-Fiebert JD, Rangel E, Dietch JR, Tutek J, Palaniappan L. Effects of a Triage Checklist to optimize insomnia treatment outcomes and reduce hypnotic use: the RCT of the effectiveness of stepped-care sleep therapy in general practice study. Sleep. 2025 Jan 13;48(1):zsae182. doi: 10.1093/sleep/zsae182. | |
| 36883379 | Derived | Tully IA, Kim JP, Simpson N, Palaniappan L, Tutek J, Gumport NB, Dietch JR, Manber R. Beliefs about prescription sleep medications and interest in reducing hypnotic use: an examination of middle-aged and older adults with insomnia disorder. J Clin Sleep Med. 2023 Jul 1;19(7):1247-1257. doi: 10.5664/jcsm.10552. |
Not provided
Not provided
The researchers will share fully de-identified data on: the two primary outcomes, allocation to arm, and demographic.
Data will become available 2 years after the publication of the results pertaining to the primary aims. Data will be available for 2 years after its release
Data will be shared only with investigators who have a clear and rigorous analytic plan and who sign a data use agreement with Stanford University.
Not provided
388 participants signed consent. 254 were eligible and 245 were randomized to a study arm
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ONLINE ONLY (ONLN) | Online cognitive behavioral therapy for insomnia |
| FG001 | STEPPED CARE (STEP) | Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ONLN | Online cognitive behavioral therapy for insomnia |
| BG001 | STEP | Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intent to treat sample; values for participants with available data at the respective time point | Posted | Mean | Standard Deviation | score on a scale | at baseline and at months 2, 4, 6, 9, & 12 |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ONLN | Online cognitive behavioral therapy for insomnia | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not related to study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | Psychiatric disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Manber, PhD | Stanford University | (650) 498-9111 | rmanber@stanford.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 1, 2020 | Dec 5, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 9, 2024 | Dec 9, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2021 | Dec 9, 2024 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
| STEPPED CARE |
| Behavioral |
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 |
|
| 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). | at baseline and at months 2, 4, 6, 9, & 12 |
| 35367385 | Derived | Manber R, Tully IA, Palaniappan L, Kim JP, Simpson N, Zulman DM, Goldhaber-Fiebert JD, Rangel E, Dietch JR, Rosas LG. RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol. Contemp Clin Trials. 2022 May;116:106749. doi: 10.1016/j.cct.2022.106749. Epub 2022 Mar 30. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insomnia Severity Index (ISI) | The ISI is an empirically validated 7-item questionnaire, with each item rated on a 4-point 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. | Mean | Standard Deviation | Score on a scale |
|
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both |
|
|
|
| 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. | Intent to treat sample; values for participants with available data at the respective time point | Posted | Mean | Standard Deviation | Average number of minimal doses | at baseline and at months 2, 4, 6, 9, & 12 |
|
|
|
|
| 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. | Intent to treat sample; values for participants with available data at the respective time point | Posted | Mean | Standard Deviation | T score | at baseline and at months 2, 4, 6, 9, & 12 |
|
|
|
|
| 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). | Intent to treat sample; values for participants with available data at the respective time point | Posted | Mean | Standard Deviation | units on a scale | at baseline and at months 2, 4, 6, 9, & 12 |
|
|
|
|
| 121 |
| 1 |
| 121 |
| 8 |
| 121 |
| EG001 | STEP | Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both | 1 | 124 | 1 | 124 | 9 | 124 |
|
| Surgical complications | Surgical and medical procedures | Systematic Assessment | Not related to study treatment |
|
| Sleepiness | Psychiatric disorders | Systematic Assessment |
|
| Worsening of sleep | Psychiatric disorders | Systematic Assessment |
|
| Stress about sleep | Psychiatric disorders | Systematic Assessment |
|
| Discomfort due to not enough sl | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |
| 2-month |
|
|
| 4-month |
|
|
| 6-month |
|
|
| 9-month |
|
|
| 12-month |
|
|
| 2-month |
|
|
| 4-month |
|
|
| 6-month |
|
|
| 9-month |
|
|
| 12-month |
|
|
| 2-month |
|
|
| 4-month |
|
|
| 6-month |
|
|
| 9-month |
|
|
| 12-month |
|
|