Clinical trial NCT04661306: The Better Sleep for Supporters With Insomnia Study
Official title: Optimizing Efficiency and Impact of Internet-delivered Insomnia Treatment for Cancer Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregivers
Cancer
Insomnia
Sleep Initiation and Maintenance Disorders
Keywords: Family Caregivers
Cancer
Insomnia
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will identify whether - and if so, how - tailoring would increase adoption of and benefit from an interactive internet intervention for insomnia called SHUTi (Sleep Healthy Using the Internet) for cancer caregivers. Participating caregivers' sleep and sleep-related characteristics will be characterized from a baseline assessment; then, caregivers will receive complementary and voluntary access to SHUTi. Among caregivers who choose to use SHUTi, intervention use, perceived appropriateness, and effects on sleep and quality of life will be assessed. Among caregivers who choose not to use SHUTi, reasons and barriers to using the intervention will be assessed.

Detailed description: Insomnia is a significant public health problem with substantial medical, psychological and financial ramifications. About 50-75% of the 3.5 million Americans who provide unpaid medical, practical, and/or emotional support for a loved one with cancer endorse clinically significant sleep disturbance. Understanding caregivers' psychosocial risk factors and needs, and the extent to which these are unique to the cancer caregiving context, will ensure appropriate and effective interventions for cancer caregivers with insomnia.

Existing psychosocial services for caregivers are primarily delivered in-person. Although such interventions are effective, they suffer from low enrollment, high dropout, and limited reach to caregivers who already have inadequate healthcare access, like caregivers from lower SES or those in rural areas. Digital health interventions can lower barriers to entry to supportive care for caregivers as they are conveniently accessible anywhere and anytime from an Internet-enabled device. Sleep Healthy Using the Internet (SHUTi) is a NCI-designated research-tested intervention that delivers cognitive-behavioral therapy for insomnia (CBT-I) and holds significant potential to accessibly treat insomnia for cancer caregivers. Most digital health interventions tested among caregivers, however, have been developed de novo for specific caregiving contexts. The implicit assumption underlying highly tailored interventions for caregivers is that caregivers have different deficits, risk factors, and needs from non-caregivers. This assumption has not often been tested, and therefore the extent to which caregivers want and need tailoring for digital health interventions is not known. This study is therefore designed to provide the data necessary to ensure the highest quality, impact, and efficiency from existing evidence-based digital health interventions to meet pressing psychosocial needs among cancer caregivers. Specifically, this study will directly inform next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers.

The SHUTi Program: SHUTi is a self-guided (i.e., automated), interactive, and tailored web-based program modeled on the primary tenants of face-to-face CBT-I (sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, relapse prevention). Intervention content is metered out over time through 6 "Cores." Users obtain access to a new Core based on a time and event-based schedule (e.g., 7 days after completion of previous Core). This schedule is consistent with the recommendation from a task force commissioned by the Academy of Sleep Medicine, which deemed that an average of 6 - 8 sessions constitutes "adequate treatment exposure". The SHUTi program relies on user-entered online Sleep Diaries to track progress and to tailor treatment recommendations (i.e., assign a "sleep restriction" window). Each Core acts as an online analog for the weekly sessions typically used when delivering CBT-I in a face-to-face format, following the same general structure: 1) Core objectives (what will be learned and why this information is important), 2) review of previous week's homework and sleep diary data, 3) new intervention material, 4) assignment of homework (treatment strategies for the coming week), and 5) a summary of the Core's main points. Intervention content is enhanced through a variety of interactive features, including personalized goal-setting, graphical feedback based on inputted symptoms, animations / illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Automated emails are also sent to encourage program adherence. There is no content that is specifically about cancer or caregiving.

Caregivers participating in this study will complete a baseline assessment (questionnaires and 2 weeks of daily sleep diaries), and then will receive complementary and voluntary access to SHUTi. Participants who choose to complete 1 or more SHUTi Cores will complete a follow-up assessment of questionnaires and 2 weeks of sleep diaries; participants who choose not to complete any SHUTi cores will be asked to provide brief feedback regarding their reasons/barriers.

Eligibility criteria: Inclusion Criteria:

* self-report providing unpaid care (e.g., practical, medical, and/or emotional support) to an adult family member or "family-like" close individual who is either currently undergoing any anti-cancer treatment (e.g., surgery, chemotherapy, radiation, for either curative or palliative intent) or has completed anti-cancer treatment within the past 2 years.
* Insomnia severity index score of 10 or higher
* age 18 and over
* regular access (at least 2/week) and willingness to use a computer and the Internet and check email
* ability to read and speak English
* resident of the US

Exclusion Criteria:

* irregular sleep schedules that prevent the ability to follow intervention recommendations (i.e., with usual bedtimes outside of 8:00pm to 2:00am or arising time outside of 4:00am to 10:00am)
* current psychological treatment for insomnia
* screen positive for a history of psychotic or bipolar disorder; and current severe depression, high risk of suicide, substance use (alcohol, drug) disorder within the past year
* symptoms suggestive of untreated sleep disorders other than insomnia (e.g., obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder)
* presence of uncontrolled medical condition that is deemed to interfere with the study procedures, or put the study participant at undue risk
* Unstable medication regimen (change to schedule or dosage within past 3 months) for a prescription medication regimen thought to impact sleep.

Primary outcomes:
measure: SHUTi Usage
timeFrame: 9 weeks
Secondary outcomes:
measure: Insomnia severity
timeFrame: Baseline, 9 weeks
measure: Sleep onset latency (SOL)
timeFrame: Baseline, 9 weeks
measure: Wake after sleep onset (WASO)
timeFrame: Baseline, 9 weeks
measure: Perceived sleep quality
timeFrame: Baseline, 9 weeks
measure: Sleep-related cognitions
timeFrame: Baseline, 9 weeks
measure: Sleep self-efficacy
timeFrame: Baseline, 9 weeks
measure: Internal and chance sleep locus of control
timeFrame: Baseline, 9 weeks
measure: Caregiving burden
timeFrame: Baseline, 9 weeks
measure: Caregiving competence
timeFrame: Baseline, 9 weeks
measure: Physical Function
timeFrame: Baseline, 9 weeks
measure: Anxiety
timeFrame: Baseline, 9 weeks
measure: Depression
timeFrame: Baseline, 9 weeks
measure: Fatigue
timeFrame: Baseline, 9 weeks
measure: Sleep Disturbance
timeFrame: Baseline, 9 weeks
measure: Social functioning
timeFrame: Baseline, 9 weeks
measure: Pain Interference
timeFrame: Baseline, 9 weeks
measure: Pain Intensity
timeFrame: Baseline, 9 weeks
measure: Experiences with Internet intervention
timeFrame: 9 weeks
measure: Perceptions of Internet intervention
timeFrame: 9 weeks
measure: Adherence to Internet intervention
timeFrame: 9 weeks
measure: SHUTi Feasibility as assessed by open-ended feedback
timeFrame: 9 weeks
measure: SHUTi Acceptability as assessed by open-ended feedback
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Kelly Shaffer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ritterband LM, Thorndike FP, Ingersoll KS, Lord HR, Gonder-Frederick L, Frederick C, Quigg MS, Cohn WF, Morin CM. Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):68-75. doi: 10.1001/jamapsychiatry.2016.3249.
citation: Shaffer KM, Garland SN, Mao JJ, Applebaum AJ. Insomnia among Cancer Caregivers: A Proposal for Tailored Cognitive Behavioral Therapy. J Psychother Integr. 2018 Sep;28(3):275-291. doi: 10.1037/int0000105.