Recruiting

Insomnia Treatment

Sponsor:

University of Michigan

Code:

NCT06580561

Conditions

Knee Osteoarthritis

Insomnia

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Personalized exercise coaching

Cognitive behavioral therapy for Insomnia

Study Details

Brief summary:

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.

Conditions

Knee Osteoarthritis

Insomnia

Study ID

NCT06580561

Start date

Nov 4, 2024

Status verified date

Apr, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Feb 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Self-reported physician diagnosis of knee osteoarthritis
  • Persistent knee osteoarthritis-related pain of at least moderate intensity (as indicated in the protocol)
  • Indication of persistent symptoms of insomnia, determined by scoring on the Sleep Condition Indicator questionnaire (as indicated in the protocol)
  • If receiving medication for pain or sleep disturbances, having had no change in prescription in the previous three months and be willing to make no other changes to medications for pain or sleep during the active study period.
  • Adequate literacy level to ensure web-based surveys can be completed independently, as assessed using a brief 3-item literacy level screener

Exclusion Criteria:

  • Concurrent diagnosis of a systemic, inflammatory musculoskeletal disorder (e.g., rheumatoid arthritis)
  • Active malignancy
  • Neurological conditions (e.g., movement disorders)
  • Any medical condition which would make graded increase of physical activity unsuitable (determined by a positive answer to the question: "Has a doctor or healthcare professional advised you to avoid physical activity for any reason?").
  • Unable to understand English sufficiently to take part in the intervention.
  • Unable to provide electronic informed consent.
  • Evidence of significant cognitive impairment (i.e., ≥2 errors on a 6-item cognitive screener).
  • Presence of severe psychiatric disorder.
  • Currently participating in an interventional trial or a pain or sleep management program or having done so in the past six months.
  • Visual or hearing impairment that would prevent use of the intervention.
  • Serious physical health concerns necessitating surgery or with a prognosis <6 months
  • Irregular sleep-wake schedule, e.g., shift work.
  • Self-report of diagnosis of a specific sleep disorder other than insomnia that is not currently adequately treated, e.g., sleep apnea or narcolepsy.
  • Currently meeting or exceeding physical activity guidance from the U.S. Department of Health and Human Services (noted in protocol)

Study Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Move and Snooze program

This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I).

experimental: Personalized exercise program

Interventions

Personalized exercise coaching

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

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.

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 and Locations

Central contacts

Jade Treder

734-936-2844trederj@med.umich.edu

Kristin Pickup

734-764-4072knpicku@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Jade Treder

734-936-2844trederj@med.umich.edu

Principal Investigator:

Daniel Whibley, PhD

More Information

Sponsor

University of Michigan

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Exercise coaching
  • Cognitive behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-04-13.