The Better Sleep for Supporters With Insomnia Study

Cancer Clinical Trial

— BeSSI  

Official title:

Optimizing Efficiency and Impact of Internet-delivered Insomnia Treatment for Cancer Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661306
• Other study ID #: 3809
• Status: Completed
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: May 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Family Caregivers
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• SHUTi (Sleep Healthy Using the Internet)
Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SHUTi Usage	Number of SHUTi Cores completed by participants	9 weeks
Secondary	Insomnia severity	Insomnia severity index; 7 items; summed scores range from 0 to 28 (higher scores indicate more severe insomnia symptoms)	Baseline, 9 weeks
Secondary	Sleep onset latency (SOL)	Data collected from sleep diary: Time fell asleep - Time attempting to fall asleep	Baseline, 9 weeks
Secondary	Wake after sleep onset (WASO)	Data collected from sleep diary: Total time awake between time feel asleep and final morning waking	Baseline, 9 weeks
Secondary	Perceived sleep quality	Data collected from sleep diary: Nightly rating of perceived sleep quality from very poor to very good	Baseline, 9 weeks
Secondary	Sleep-related cognitions	Dysfunctional Beliefs and Attitudes about Sleep; 16 items; averaged scores range from 0 to 10 (higher scores indicate more dysfunctional attitudes and beliefs about sleep)	Baseline, 9 weeks
Secondary	Sleep self-efficacy	Sleep Self-Efficacy Scale; 13-items; averaged scores range from 0 to 10 (higher scores indicate greater self-efficacy)	Baseline, 9 weeks
Secondary	Internal and chance sleep locus of control	Sleep Locus of Control Scale; 4-item subscales for internal and chance locus of control, respectively; averaged scores per scale range from 1 to 6 (higher scores indicate higher belief in the locus of control measured)	Baseline, 9 weeks
Secondary	Caregiving burden	Pearlin Stress Scale - Overload subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived burden)	Baseline, 9 weeks
Secondary	Caregiving competence	Pearlin Stress Scale - Caregiving Competence subscale; 4 items; averaged scores range from 1 to 4 (higher scores indicate greater perceived competence)	Baseline, 9 weeks
Secondary	Physical Function	PROMIS SF v2.0 - Physical Function 8b; 8 items; scored on a normalized T-score distribution (higher scores indicate higher physical function)	Baseline, 9 weeks
Secondary	Anxiety	PROMIS SF v2.0 - Anxiety 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher anxiety)	Baseline, 9 weeks
Secondary	Depression	PROMIS SF v2.0 - Depression 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher depression)	Baseline, 9 weeks
Secondary	Fatigue	PROMIS SF v2.0 - Fatigue 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher fatigue)	Baseline, 9 weeks
Secondary	Sleep Disturbance	PROMIS SF v2.0 - Sleep Disturbance 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher sleep disturbance)	Baseline, 9 weeks
Secondary	Social functioning	PROMIS SF v2.0 - Ability to Participant in Social Roles and Activities 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher social function)	Baseline, 9 weeks
Secondary	Pain Interference	PROMIS SF v2.0 - Pain Interference 8a; 8 items; scored on a normalized T-score distribution (higher scores indicate higher pain interference)	Baseline, 9 weeks
Secondary	Pain Intensity	PROMIS SF v2.0 - Pain Intensity item; 1 item (higher score indicate higher pain intensity)	Baseline, 9 weeks
Secondary	Experiences with Internet intervention	Internet Intervention Utility Questionnaire (UQ) for SHUTi; 18 items; items examined individually	9 weeks
Secondary	Perceptions of Internet intervention	Internet Intervention Impact and Effectiveness Questionnaire (IEQ) for SHUTi; 29 items; items examined individually	9 weeks
Secondary	Adherence to Internet intervention	Internet Intervention Adherence Questionnaire (AQ) for SHUTi; 20 items; items examined individually	9 weeks
Secondary	SHUTi Feasibility as assessed by open-ended feedback	Open-ended survey items regarding barriers to using SHUTi	9 weeks
Secondary	SHUTi Acceptability as assessed by open-ended feedback	Open-ended survey items regarding appropriateness of SHUTi to address caregivers' sleep needs	9 weeks

External Links

•   BeSSI Interest Website
•   Center for Behavioral Health and Technology website