Sleep DisturbanceNCT04409743
Brief Telehealth CBT-I Intervention in the Context of the COVID-19 Pandemic
A study testing Remote Cognitive Behavioral Therapy for Insomnia in people with Sleep Disturbance and Insomnia, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether an empirically validated treatment for insomnia (CBT-I) administered early in the course of sleep disturbance can prevent insomnia disorder or lessen negative mental health outcomes in the wake of the COVID-19 crisis in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Insomnia
- What is being tested?
- Remote Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2020to 19 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Access to the internet
- Subjective complaint of sleep disturbance (ISI ≥10) that began after March 1, 2020 or the COVID-19 Pandemic (self-reported during DUKE Interview)
- Lives in the United States
Who cannot join
- Presence of suicidal ideation representing high risk as measured by the Sheehan-Suicide Tracking Scale (S-STS).
- Use of medication specifically prescribed for sleep disturbance and unwilling or unable to discontinue more than one week prior to baseline data collection.
- Current or lifetime history of bipolar disorder or psychosis
- Current substance abuse or dependence
- Not able to verbalize understanding of involvement in research and provide written, informed consent
- Not fluent or literate in English
Show all 9Show fewer
- Unstable pharmacotherapy for other mental health disorders
- Severe impediment to vision, hearing, and/or hand movement, likely to interfere with the ability to complete assessments, or are unable and/or unlikely to follow study protocols
- Working rotating shift that overlaps with 2400h
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep, Suicidality, and Neuropsychiatric Symptoms
The purpose of this study is to investigate whether an empirically validated treatment for insomnia (CBT-I) administered early in the course of sleep disturbance can prevent insomnia disorder or lessen negative mental health outcomes in the wake of the COVID-19 crisis in adults.
Read the detailed description
The COVID-19 Pandemic and the resulting mass home confinement enacted to mitigate disease spread has created an environment of stress and drastic disruption to daily life. Increases in stress, social isolation, loss of daily routine, decreased physical activity, and excess screen time that are likely to arise as a function of the pandemic and mitigation efforts are risk factors for developing insomnia. Left unchecked, this acute insomnia can become chronic, resulting in increased risk of negative mental health outcomes such as depression, anxiety, and suicidality. The current proposal aims to test whether a telehealth intervention for insomnia can be used to not only prevent the progression of acute to chronic insomnia, but also prevent the worsening of neuropsychiatric symptoms, suicidality, and quality of life in those most vulnerable to negative mental health outcomes.
These aims will be achieved through a randomized 2-arm controlled trial design. 50 eligible adults experiencing sleep disturbances and who also have a history of depression and are in the at-risk group for COVID-19 will be randomized to receive either a sleep intervention (Cognitive Behavioral Therapy for Insomnia, CBT-I; n=25) or a 7-month waitlist (n=25). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, Quality of Life, suicidality, and sleep disruption will be assessed at baseline (Week 0) and at the end of the sleep intervention (or Week 7) through online surveys and clinical interviews. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout treatment/waitlist to assess week-to-week changes following an increasing number of CBT-I sessions. Neuropsychiatric symptoms, quality of life, suicidality, and sleep will be assessed again at 3-months, 7-months, and 13-months after baseline.
- Conditions
- Sleep Disturbance, Insomnia
- Being tested
- Remote Cognitive Behavioral Therapy for Insomnia
- Keywords
- Sleep, CBT-I, Cognitive Behavioral Therapy, COVID-19
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
Participants will meet with a psychologist through telehealth once a week for four weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Active comparator | The sleep treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants randomized to this arm will begin treatment immediately after randomization. Receives: Behavioral: Remote Cognitive Behavioral Therapy for Insomnia |
| Waitlist | Other | The subjects assigned to the Waitlist condition will receive the same CBT-I treatment 7 months after randomization. Receives: Behavioral: Remote Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Clinical Diagnosis Over Time
Whether the participant has an insomnia clinical diagnosis will be measured by the DUKE. The DUKE is a structured interview which screens for sleep disorders in accordance with criteria of both the DSM-IV and the international classification of sleep disorders (ICSD-2). The DUKE is composed of 4 modules that assess sleep disorder symptoms associated with complaints of insomnia, sleep disorders associated with complaints of hypersomnia, circadian rhythm sleep disorders, and sleep disorders associated with parasomnias.
Measured: Assessed at week 0, month 3, month 7, and month 13
Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms Over Time
The PHQ-9 is a self-administered 9-item 0 to 3 scale (0 = not at all, 3 = nearly every day) questionnaire that assess each of the 9 DSM-IV depression criteria. The total score ranges from 1 - 27 which measures the severity of the reported depression with consideration for both Major Depressive Disorder and other depressive disorders based on the number of items that were rated a 2 to 3.
Measured: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score Over Time
The GAD-7 is a widely used diagnostic self- report scale that screens, diagnoses, and assess severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Measured: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Insomnia Severity Index (ISI) Scale Score Over Time
Subjective ratings of sleep disturbance and insomnia severity will be assessed with the Insomnia Severity Index. The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia type, severity, and impact on functioning. The items consist of severity of sleep onset, sleep maintenance, early morning awakenings, sleep dissatisfaction, interference with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Items are scored from 0 to 4 (0 = no problem, 4 = very severe problem). Score ranges of insomnia are: 0-7 absent, 8-14 sub-threshold, 15-21 moderate, and 22-28 severe. The ISI has good validity and reliability.
Measured: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Quality of Life (SF-36) Scale Score Over Time
The SF-36 is a 36-item self-administered survey to assess comprehensive quality-of-life measures. It consists of eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, and mental health. This survey is widely used and has been proven to be a reliable indicator of quality-of-life measures. The global score range is 0-100, with higher scores indicating better health conditions.
Measured: Assessed at week 0, month 3, month 7, and month 13
Change in Sheehan Suicidality Tracking Scale (S-STS) Score Over Time
Suicidality ideation and behaviors will be measured by the S-STS. The S-STS is a 16-item 0 to 4 scale (0 = no problem, 4 = very severe problem) that assesses the risk of suicidality. For this outcome measure, 15 items (excluding #13) are summed for an overall score range of 0 to 45 (higher scores indicate more severe problems).
Measured: Assessed at week 0, month 3, month 7, and month 13
Change in UCLA Loneliness Scale Score Over Time
Loneliness risk factors will be assessed with the UCLA Loneliness Scale that measures a participant's subjective feelings of loneliness and social isolation. The UCLA Loneliness Scale has 20 items, each on a 1 to 4 scale (1 = Never, 4 = Often), summed for an overall range of 20 to 80 with higher scores indicating greater degrees of loneliness.
Measured: Assessed at week 0, month 3, month 7, and month 13
Change in Social Network Index (SNI) Scale Score Over Time
The Social Network Index is a 12-item questionnaire that assess participation in different types of social relationships. The 12 types of relationships (e.g. friend, children, spouse, religious group member) are scored by the number network members they communicate with at least every 2 weeks.
Measured: Assessed at week 0, month 7, and month 13
Change in Perceived Stress Scale Score Over Time
The Perceived Stress Scale is a widely used self-reported questionnaire that assesses how stressful participants believe their live is. Items are generalized and measure the degree participants judge their lives to be uncontrollable and unpredictable over the course of the previous month.
Measured: Assessed at week 0, month 3, month 7, and month 13
Change in Screen Time- Self Report Over Time
Self-report questions regarding screen time will be included in the Coronavirus Health Impact Survey. Questions measure the amount of time spent per day, over the course of the two most recent weeks, using an electronic device.
Measured: Assessed at week 0, week 7, month 3, month 7, and month 13
Change in International Physical Activity Questionnaire (IPAQ) Scale Score Over Time
The International Physical Activity Questionnaire assess an individual's physical activity across 5 life domains over the last 7 days. The activity domains consist of physical activity related to work, transportation, housework and caring for family, and recreation and sports as well as the amount of time spent sitting. The IPAQ has high reliability and validity and has been widely used to measure comparable estimates of physical activity in large populations.
Measured: Assessed at week 0, month 3, month 7, and month 13
Secondary outcomes (7)
Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity Over Time
Sleep Onset Latency (SOL) is the time (minutes) from "lights out" to actually falling asleep (sleep onset) based on sleep logs.
Measured: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Number of Awakenings as a Measure of Sleep Continuity Over Time
Number of Awakenings is determined by number of times of awakening as reported on sleep logs.
Measured: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity Over Time
Wake After Sleep Onset (WASO) are periods of wakefulness occurring after sleep onset, before final awakening (sleep offset).
Measured: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Total Sleep Time (TST) as a Measure of Sleep Continuity Over Time
Total Sleep Time (TST) is the total time spent asleep, from the start of sleep onset to sleep offset subtracting any periods of wakefulness.
Measured: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity Over Time
Sleep Efficiency (SE) is calculated as TST divided by total time spent in bed, multiplied by 100.
Measured: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Beck Depression Inventory-II (BDI) Scale Score Over Time
This measure is of the Beck Depression Inventory-II total score after excluding one sleep item. The average item score for the remaining 20 items will be multiplied by 21 (the original number of items), to create a modified depression scale that maintains the original range (ranges: 0-13 minimal, 14-19 mild, 20-28 moderate, and 29-63 severe).
The BDI-II is a 21-item self-report scale with high validity and reliability that assesses the severity of depression symptoms. The depression items consist of: sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. Items are scored from 0 to 3, and higher scores indicate greater levels of severity.
Measured: Assessed at week 0, month 3, month 7, and month 13
Change in Beck Anxiety Inventory (BAI) Scale Score Over Time
Clinical anxiety symptoms will be measured by the BAI. The BAI is a 21-item self-report scale that assesses the severity of anxiety symptoms. Items are scored from 0 to 3 (0 = not at all, 3 = severe). Higher scores indicate greater levels of severity, and the ranges for anxiety levels are: 0-9 normal to minimal, 10-18 mild to moderate, 19-29 moderate to severe, and 30-63 severe. The BAI consists of two factors: somatic and cognitive.
Measured: Assessed at week 0, month 3, month 7, and month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start7 Jun 2020
- Primary completion14 Oct 2021
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Goldstein-Piekarski, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409743
- Sponsor's protocol ID
- IRB-55940
- Status last verified
- Jun 2022
- First submitted
- 28 May 2020
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Hora KP, Osorno RA, Sadeghi-Bahmani D, Lopez M, Morehouse A, Kim JP, Manber R, Goldstein-Piekarski AN. Viability of an Early Sleep Intervention to Mitigate Poor Sleep and Improve Well-being in the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 14;11(3):e34409. doi: 10.2196/34409.
PubMed 34995204
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep, Suicidality, and Neuropsychiatric Symptoms
- ClinicalTrials.gov ID
- NCT04409743
- Acronym / sponsor ID
- IRB-55940
- Conditions
- Sleep Disturbance, Insomnia
- Keywords
- Sleep, CBT-I, Cognitive Behavioral Therapy, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 1 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether an empirically validated treatment for insomnia (CBT-I) administered early in the course of sleep disturbance can prevent insomnia disorder or lessen negative mental health outcomes in the wake of the COVID-19 crisis in adults.
Detailed description
The COVID-19 Pandemic and the resulting mass home confinement enacted to mitigate disease spread has created an environment of stress and drastic disruption to daily life. Increases in stress, social isolation, loss of daily routine, decreased physical activity, and excess screen time that are likely to arise as a function of the pandemic and mitigation efforts are risk factors for developing insomnia. Left unchecked, this acute insomnia can become chronic, resulting in increased risk of negative mental health outcomes such as depression, anxiety, and suicidality. The current proposal aims to test whether a telehealth intervention for insomnia can be used to not only prevent the progression of acute to chronic insomnia, but also prevent the worsening of neuropsychiatric symptoms, suicidality, and quality of life in those most vulnerable to negative mental health outcomes.
These aims will be achieved through a randomized 2-arm controlled trial design. 50 eligible adults experiencing sleep disturbances and who also have a history of depression and are in the at-risk group for COVID-19 will be randomized to receive either a sleep intervention (Cognitive Behavioral Therapy for Insomnia, CBT-I; n=25) or a 7-month waitlist (n=25). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, Quality of Life, suicidality, and sleep disruption will be assessed at baseline (Week 0) and at the end of the sleep intervention (or Week 7) through online surveys and clinical interviews. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout treatment/waitlist to assess week-to-week changes following an increasing number of CBT-I sessions. Neuropsychiatric symptoms, quality of life, suicidality, and sleep will be assessed again at 3-months, 7-months, and 13-months after baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Active comparator | Behavioral: Remote Cognitive Behavioral Therapy for InsomniaThe sleep treatment is Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants randomized to this arm will begin treatment immediately after randomization. |
| Waitlist | Other | Behavioral: Remote Cognitive Behavioral Therapy for InsomniaThe subjects assigned to the Waitlist condition will receive the same CBT-I treatment 7 months after randomization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older
- Access to the internet
- Subjective complaint of sleep disturbance (ISI ≥10) that began after March 1, 2020 or the COVID-19 Pandemic (self-reported during DUKE Interview)
- Lives in the United States
Key exclusion criteria (9 listed)
- Presence of suicidal ideation representing high risk as measured by the Sheehan-Suicide Tracking Scale (S-STS).
- Use of medication specifically prescribed for sleep disturbance and unwilling or unable to discontinue more than one week prior to baseline data collection.
- Current or lifetime history of bipolar disorder or psychosis
- Current substance abuse or dependence
- Not able to verbalize understanding of involvement in research and provide written, informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Cognitive Behavioral Therapy for InsomniaAlso: CBT-IParticipants will meet with a psychologist through telehealth once a week for four weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation. | Behavioural | Immediate Treatment, Waitlist |
Primary outcome
Change in Insomnia Clinical Diagnosis Over Time
Time frame: Assessed at week 0, month 3, month 7, and month 13
Whether the participant has an insomnia clinical diagnosis will be measured by the DUKE. The DUKE is a structured interview which screens for sleep disorders in accordance with criteria of both the DSM-IV and the international classification of sleep disorders (ICSD-2). The DUKE is composed of 4 modules that assess sleep disorder symptoms associated with complaints of insomnia, sleep disorders associated with complaints of hypersomnia, circadian rhythm sleep disorders, and sleep disorders associated with parasomnias.
Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms Over Time
Time frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
The PHQ-9 is a self-administered 9-item 0 to 3 scale (0 = not at all, 3 = nearly every day) questionnaire that assess each of the 9 DSM-IV depression criteria. The total score ranges from 1 - 27 which measures the severity of the reported depression with consideration for both Major Depressive Disorder and other depressive disorders based on the number of items that were rated a 2 to 3.
Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score Over Time
Time frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
The GAD-7 is a widely used diagnostic self- report scale that screens, diagnoses, and assess severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Change in Insomnia Severity Index (ISI) Scale Score Over Time
Time frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Subjective ratings of sleep disturbance and insomnia severity will be assessed with the Insomnia Severity Index. The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia type, severity, and impact on functioning. The items consist of severity of sleep onset, sleep maintenance, early morning awakenings, sleep dissatisfaction, interference with daytime functioning, noticeability of sleep problems by others, and distress caused by sleep difficulties. Items are scored from 0 to 4 (0 = no problem, 4 = very severe problem). Score ranges of insomnia are: 0-7 absent, 8-14 sub-threshold, 15-21 moderate, and 22-28 severe. The ISI has good validity and reliability.
Change in Quality of Life (SF-36) Scale Score Over Time
Time frame: Assessed at week 0, month 3, month 7, and month 13
The SF-36 is a 36-item self-administered survey to assess comprehensive quality-of-life measures. It consists of eight sections: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, and mental health. This survey is widely used and has been proven to be a reliable indicator of quality-of-life measures. The global score range is 0-100, with higher scores indicating better health conditions.
Change in Sheehan Suicidality Tracking Scale (S-STS) Score Over Time
Time frame: Assessed at week 0, month 3, month 7, and month 13
Suicidality ideation and behaviors will be measured by the S-STS. The S-STS is a 16-item 0 to 4 scale (0 = no problem, 4 = very severe problem) that assesses the risk of suicidality. For this outcome measure, 15 items (excluding #13) are summed for an overall score range of 0 to 45 (higher scores indicate more severe problems).
Change in UCLA Loneliness Scale Score Over Time
Time frame: Assessed at week 0, month 3, month 7, and month 13
Loneliness risk factors will be assessed with the UCLA Loneliness Scale that measures a participant's subjective feelings of loneliness and social isolation. The UCLA Loneliness Scale has 20 items, each on a 1 to 4 scale (1 = Never, 4 = Often), summed for an overall range of 20 to 80 with higher scores indicating greater degrees of loneliness.
Change in Social Network Index (SNI) Scale Score Over Time
Time frame: Assessed at week 0, month 7, and month 13
The Social Network Index is a 12-item questionnaire that assess participation in different types of social relationships. The 12 types of relationships (e.g. friend, children, spouse, religious group member) are scored by the number network members they communicate with at least every 2 weeks.
Change in Perceived Stress Scale Score Over Time
Time frame: Assessed at week 0, month 3, month 7, and month 13
The Perceived Stress Scale is a widely used self-reported questionnaire that assesses how stressful participants believe their live is. Items are generalized and measure the degree participants judge their lives to be uncontrollable and unpredictable over the course of the previous month.
Change in Screen Time- Self Report Over Time
Time frame: Assessed at week 0, week 7, month 3, month 7, and month 13
Self-report questions regarding screen time will be included in the Coronavirus Health Impact Survey. Questions measure the amount of time spent per day, over the course of the two most recent weeks, using an electronic device.
Change in International Physical Activity Questionnaire (IPAQ) Scale Score Over Time
Time frame: Assessed at week 0, month 3, month 7, and month 13
The International Physical Activity Questionnaire assess an individual's physical activity across 5 life domains over the last 7 days. The activity domains consist of physical activity related to work, transportation, housework and caring for family, and recreation and sports as well as the amount of time spent sitting. The IPAQ has high reliability and validity and has been widely used to measure comparable estimates of physical activity in large populations.
7 secondary outcomes
Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity Over Time
Time frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Number of Awakenings as a Measure of Sleep Continuity Over Time
Time frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity Over Time
Time frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Total Sleep Time (TST) as a Measure of Sleep Continuity Over Time
Time frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity Over Time
Time frame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
Change in Beck Depression Inventory-II (BDI) Scale Score Over Time
Time frame: Assessed at week 0, month 3, month 7, and month 13
Change in Beck Anxiety Inventory (BAI) Scale Score Over Time
Time frame: Assessed at week 0, month 3, month 7, and month 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Results publication: PubMed 34995204O'Hora KP, Osorno RA, Sadeghi-Bahmani D, Lopez M, Morehouse A, Kim JP, Manber R, Goldstein-Piekarski AN. Viability of an Early Sleep Intervention to Mitigate Poor Sleep and Improve Well-being in the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2022 Mar 14;11(3):e34409. doi: 10.2196/34409.
- Individual participant dataSharing planned: No
Related trials for Sleep Disturbance
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Goldstein-Piekarski, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Cognitive Behavioral Therapy for Insomnia in people with Sleep Disturbance and Insomnia, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Clinical Diagnosis Over Time (time frame: Assessed at week 0, month 3, month 7, and month 13). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04409743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.