Clinical trial NCT04409743: Brief Telehealth CBT-I Intervention in the Context of the COVID-19 Pandemic
Official title: Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep, Suicidality, and Neuropsychiatric Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Insomnia
Keywords: Sleep
CBT-I
Cognitive Behavioral Therapy
COVID-19
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in Insomnia Clinical Diagnosis Over Time
timeFrame: Assessed at week 0, month 3, month 7, and month 13
measure: Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms Over Time
timeFrame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
measure: Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score Over Time
timeFrame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
measure: Change in Insomnia Severity Index (ISI) Scale Score Over Time
timeFrame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
measure: Change in Quality of Life (SF-36) Scale Score Over Time
timeFrame: Assessed at week 0, month 3, month 7, and month 13
measure: Change in Sheehan Suicidality Tracking Scale (S-STS) Score Over Time
timeFrame: Assessed at week 0, month 3, month 7, and month 13
measure: Change in UCLA Loneliness Scale Score Over Time
timeFrame: Assessed at week 0, month 3, month 7, and month 13
measure: Change in Social Network Index (SNI) Scale Score Over Time
timeFrame: Assessed at week 0, month 7, and month 13
measure: Change in Perceived Stress Scale Score Over Time
timeFrame: Assessed at week 0, month 3, month 7, and month 13
measure: Change in Screen Time- Self Report Over Time
timeFrame: Assessed at week 0, week 7, month 3, month 7, and month 13
measure: Change in International Physical Activity Questionnaire (IPAQ) Scale Score Over Time
timeFrame: Assessed at week 0, month 3, month 7, and month 13
Secondary outcomes:
measure: Change in Sleep Onset Latency (SOL) as a Measure of Sleep Continuity Over Time
timeFrame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
measure: Change in Number of Awakenings as a Measure of Sleep Continuity Over Time
timeFrame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
measure: Change in Wake After Sleep Onset (WASO) as a Measure of Sleep Continuity Over Time
timeFrame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
measure: Change in Total Sleep Time (TST) as a Measure of Sleep Continuity Over Time
timeFrame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
measure: Change in Sleep Efficiency (SE) as a Measure of Sleep Continuity Over Time
timeFrame: Assessed at week 0, weekly from weeks 2 to 7, month 3, month 7, and month 13
measure: Change in Beck Depression Inventory-II (BDI) Scale Score Over Time
timeFrame: Assessed at week 0, month 3, month 7, and month 13
measure: Change in Beck Anxiety Inventory (BAI) Scale Score Over Time
timeFrame: Assessed at week 0, month 3, month 7, and month 13
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Andrea Goldstein-Piekarski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.