Move and Snooze: Adding Insomnia Treatment to an Exercise Program to Improve Pain Outcomes in Older Adults With Knee Osteoarthritis

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06580561
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personalized exercise coaching — BEHAVIORAL
    This is a 6-session personalized exercise coaching program (delivered over 8 weeks). All participants will complete six 30-minute scheduled online or phone sessions with a health coach as part of a manualized personalized exercise program (once per week for the first four sessions and then once every two weeks for the remaining two sessions).
  • Cognitive behavioral therapy for Insomnia — BEHAVIORAL
    This is a 6-week course of automated, digitally delivered cognitive behavioral therapy for insomnia delivered by the online program Sleepio. The weekly sessions will last approximately 15-20 minutes. Session content comprises evidence-based cognitive and behavioral techniques including Stimulus Control Therapy and Sleep Restriction Therapy, sleep hygiene education, and relaxation exercises.

Study Details

This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain. The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.

Key Dates

Start date
Nov 4, 2024
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Move and Snooze program
    This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I).
  • Experimental: Personalized exercise program

Primary Outcome Measure

Change in average pain intensity using a 0-10 numerical rating scale between baseline and the 8-week follow-up (post-intervention) period [ Time Frame: Baseline, 8-week follow-up (post-intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Jade Treder
[email protected]
734-936-2844
Daniel Whibley, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Ann Arbor, MI

By condition
InsomniaOsteoarthritis (other)
By specialty
Mental healthSleep medicineOrthopedicsMusculoskeletal disorders
By research site
University of Michigan· Ann Arbor, MI

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