NCT00592449

Brief Summary

Osteoarthritis (OA) is one of the most common diseases and one of the leading causes of disability in the world. People with OA frequently experience sleep disturbances, primarily due to pain. Although insomnia is a known consequence of OA, recent studies have shown that it may also worsen clinical pain by interfering with the body's responses to painful stimuli. This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA. The study will test whether improvement in clinical pain are mediated by changes in certain types of pain processing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

5.8 years

First QC Date

December 28, 2007

Last Update Submit

May 22, 2019

Conditions

Sleep Initiation and Maintenance DisordersOsteoarthritis

Keywords

InsomniaKnee painOsteoarthritisArthritisSleep

Outcome Measures

Primary Outcomes (1)

  • Reduction in sleep disturbances

    Measured at Weeks 4 and 8 and Months 5 and 8

Secondary Outcomes (1)

  • Reduction in OA-related pain

    Measured at Weeks 4 and 8 and Months 5 and 8

Study Arms (6)

1

NO INTERVENTION

Participants with knee OA who meet research diagnostic criteria for insomnia will partake in Phase 1

2

NO INTERVENTION

Participants with knee OA who meet research diagnostic criteria for normal sleep will partake in Phase 1

3

NO INTERVENTION

Participants without knee OA or a pain syndrome who meet research diagnostic criteria for primary insomnia will partake in Phase 1

4

NO INTERVENTION

Participants without knee OA or a pain syndrome who meet research diagnostic criteria for normal sleep will enroll in Phase I

5

EXPERIMENTAL

Phase 1 participants with knee OA who meet research diagnostic criteria for insomnia will enroll in Phase 2 of the study and are assigned to receive behavioral desensitization treatment for insomnia

Behavioral: Behavioral desensitization treatment for insomnia

6

EXPERIMENTAL

Phase 1 participants with knee OA who meet research diagnostic criteria for insomnia will enroll in Phase 2 of the study and are assigned to receive cognitive behavior therapy for insomnia

Behavioral: Cognitive behavioral therapy (CBT) for insomnia

Interventions

Cognitive behavioral therapy (CBT) for insomniaBEHAVIORAL

During CBT, participants will learn how to change their sleeping habits and reduce arousal and alertness while trying to sleep. Participants will attend 8 weekly CBT sessions with a psychologist.

Also known as: CBT-I
6
Behavioral desensitization treatment for insomniaBEHAVIORAL

The behavioral desensitization treatment is designed to decondition states of arousal that interfere with sleep. Participants will attend 8 weekly behavioral desensitization treatment sessions with a psychologist.

5

Eligibility Criteria

Age35 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For all participants:
  • Age ≥ 50 ; or 35 ≥ if KOA/Insomnia group
  • For participants with knee OA:
  • Meets American College of Rheumatology (ACR) criteria for knee OA
  • Shows radiographic evidence of Kellgren-Lawrence Grade OA greater than or equal to 1
  • Experiences knee pain more than 5 days per week for more than 6 months
  • Reports at least typical arthritic pain (a score of at least 2 out of 10, with 0 being no pain and 10 being the most extreme pain imaginable)
  • Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen must be on a stable dose for at least 1 month prior to study entry
  • Not scheduled for arthroplasty or surgery during projected period of study participation
  • For participants with insomnia:
  • A sleep maintenance insomnia profile is evident both at study entry (based on retrospective reports) and as an average profile from 2 weeks of sleep diaries
  • Meets diagnostic criteria for insomnia due to knee OA only or for primary insomnia
  • Reports total sleep time less than 6.5 hours
  • Middle insomnia symptom frequency of more than 3 nights per week for more than 1 month
  • For participants without insomnia:
  • +11 more criteria

You may not qualify if:

  • Sleep disorders other than insomnia (e.g., obstructive sleep apnea, periodic limb movement disorder, etc.)
  • Apnea/Hypopnea Index (AHI) of greater than 15
  • Significant rheumatologic or painful disorders other than knee OA (including fibromyalgia, rheumatoid arthritis, neuralgia, etc.)
  • Any major medical diseases known to impact sleep or cause pain (including chronic obstructive pulmonary disease, diabetes, congestive heart failure, seizure disorder, Raynaud's phenomenon, etc.)
  • Dementia or cognitive impairment, defined as Mini Mental State Exam score of less than 24
  • Current or recent history of major psychiatric disorders (within 3 months prior to study entry)
  • History of schizophrenia or bipolar I disorder
  • Center for Epidemiologic Studies of Depression Scale (CES-D) greater than or equal to 27 or suicidal ideation
  • Current or history of substance abuse (within 6 months prior to study entry)
  • Use of antidepressants, antipsychotics, or mood stabilizers more than 3 days per week in the past 2 months- Note: only applies to groups other than KOA/Insomnia
  • Use of narcotics (opioids), myorelaxants, sedatives, or anticonvulsants more than 3 days per week within 1 month prior to study entry
  • Unwilling or unable to discontinue all use of certain medications by 1 week prior to study entry
  • Refuses to contact physician to obtain relevant medical record information
  • Pregnancy or plans to become pregnant within 6 months
  • Positive toxicology test (benzodiazepines and receptor agonists, barbiturates, opioids, tetrahydrocannabinol, alcohol, and stimulants)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Bayview Medical Center 5510 Nathan Shock Dr, Ste 100

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

  • Mun CJ, Speed TJ, Finan PH, Wideman TH, Quartana PJ, Smith MT. A Preliminary Examination of the Effects and Mechanisms of Cognitive Behavioral Therapy for Insomnia on Systemic Inflammation Among Patients with Knee Osteoarthritis. Int J Behav Med. 2024 Apr;31(2):305-314. doi: 10.1007/s12529-023-10184-z. Epub 2023 May 25.

    PMID: 37231221DERIVED

  • Campbell CM, Buenaver LF, Finan P, Bounds SC, Redding M, McCauley L, Robinson M, Edwards RR, Smith MT. Sleep, Pain Catastrophizing, and Central Sensitization in Knee Osteoarthritis Patients With and Without Insomnia. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1387-96. doi: 10.1002/acr.22609.

    PMID: 26041510DERIVED

  • Smith MT, Finan PH, Buenaver LF, Robinson M, Haque U, Quain A, McInrue E, Han D, Leoutsakis J, Haythornthwaite JA. Cognitive-behavioral therapy for insomnia in knee osteoarthritis: a randomized, double-blind, active placebo-controlled clinical trial. Arthritis Rheumatol. 2015 May;67(5):1221-33. doi: 10.1002/art.39048.

    PMID: 25623343DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersOsteoarthritisArthritis

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael T. Smith, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 14, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

US(1)