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.
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.
Behavioral: Remote Cognitive Behavioral Therapy for Insomnia
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.
Other Name: CBT-I
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
Stanford University
Palo Alto, California, United States
Andrea Goldstein-Piekarski, PhD, Principal Investigator
Stanford University