Sleep Healthy Using the Internet Mitigating Insomnia to Address Neurocognitive Difficulties (SHUTi MIND)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Virginia

About this trial

This randomized controlled trial will evaluate the impact of an Internet-delivered cognitive behavioral therapy for insomnia (CBT-I) intervention on sleep and the extent to which it contributes to cognitive health in individuals with mild cognitive impairment. Participants with insomnia who meet the study criteria for mild cognitive impairment will be recruited to determine the effects of the CBT-I intervention compared to a patient education condition on sleep and cognition. Internet-based recruitment methods will be used, and outcomes include sleep variables, daytime variables, and cognitive status.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged ≥ 65 years of age.

Able to speak and read English, and is a US resident.

Disqualifiers

Current psychological treatment for insomnia

Initiation of psychological or psychiatric treatment within the past three months

Current diagnosis of Huntington's or Parkinson's disease

Current treatment for hyperthyroidism

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHUTi OASIS

    Behavioral

    Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6-9 weeks in a fully automated, interactive, tailored web-based program

  • Patient Education

    Other intervention

    An educational website containing information on insomnia

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: SHUTi OASISExperimental treatment 1 intervention
Group B: Patient Education WebsitePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Insomnia Severity Index

Change in overall insomnia severity

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Secondary outcomes

1

Wake after sleep onset (WASO)

Change in periods of wakefulness occurring after defined sleep onset as measured by daily sleep diaries over 10-14 day periods, measured in minutes, collected through sleep diary entries

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
2

Sleep onset latency (SOL)

Change in length of time that it takes to transition from wakefulness to sleep, measured in minutes, collected through sleep diary entries

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
3

Multidimensional Fatigue Symptoms Inventory - Short Form

Change in self-report measures of five dimensions of fatigue ( general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor) measured using Multidimensional Fatigue Symptoms Inventory-Short Form. Total MFSI-SF scores range from 24 to 96, with a higher score indicating a higher fatigue level

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
4

Short Form-12 Health Survey (Quality of Life)

The SF-12 Health Survey will be used to measure changes in physical and mental quality of life. Scores range from 0 to 100, with higher scores indicating better physical and mental health

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Other outcomes

1

Insomnia Knowledge Scale

Sleep knowledge and cognitive behavioral therapy for insomnia techniques; scores range from 0-10 and higher scores indicate greater insomnia knowledge

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
2

Center for Epidemiologic Studies Depression Scale (CES-D)

Depression and anxiety are measured using the Center for Epidemiologic Studies Depression Scale (CES-D). Scores range from 0-60, where higher scores indicate greater likelihood of depression

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
3

Falls frequency

Falls questionnaire including number and frequency of falls

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months
4

Patient-Reported Outcomes Measurement Information System (PROMIS)

Pain intensity and interference are measured using PROMIS Pain Intensity questions. On a scale of 0-100, a score of 50 is considered the mean/reference population, and higher scores indicate greater pain intensity.

Time frame
Baseline, 9 weeks, 6 months, 12 months, 18 months, and 24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.