Sleep in Osteoarthritis Project
Condition: Sleep Initiation and Maintenance Disorders; Osteoarthritis
MeSH terms: Osteoarthritis; Sleep Initiation and Maintenance Disorders
Study type: Interventional

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.
    

Detailed description: 
      Sleep disturbance and pain are two of the most common and disabling symptoms of OA. Sleep
      disturbances have been shown to worsen clinical pain by impairing some of the body's central
      pain processing mechanisms. Sufficient research is lacking, however, on what treatments may
      be effective for sleep disturbance in people with OA or whether normalization of sleep
      patterns in people with OA will reduce their pain. This study will evaluate the effectiveness
      of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing
      clinical pain in people with knee OA.

      Participants in Phase 1 of this study will be separated into the following four groups:
      people with OA and insomnia; people with OA, but without insomnia; people without OA, but
      with insomnia; and people without OA or insomnia. All participants will attend two study
      visits. During Visit 1, participants will complete questionnaires and an interview and will
      provide a urine sample and a set of recent x-rays. A diary, which will be used to record
      activity levels for 2 weeks, will also be given to all participants.

      Optional Ancillary Sleep and Immunoreactivity Study Procedures

      Subjects who pass the visit one screen will be provided the option of participating in
      ancillary study procedures designed to assess inflammatory biomarkers present in plasma,
      physical functioning capabilities, and pain and mood status during the pain testing
      procedures. Subjects will be asked to give blood samples during the pain testing procedures,
      followed by standardized tests of physical function. Subjects will be also asked to complete
      additional questionnaire and diary items that ask them to rate their emotions during the pain
      testing procedures and during the days that they keep their electronic diary for the parent
      project. At Visit 2, participants will undergo pain testing, an in-home sleep study and
      optional procedures outlined above. At Visit 3, participants with knee osteoarthritis will
      have an exam by a rheumatologist.

      Participants in Phase 1 who have both knee OA and insomnia will be asked to continue into
      Phase 2, which will last 8 months. These participants will be randomly assigned to receive
      two different forms of behavioral treatment, cognitive behavior therapy (CBT) or a behavioral
      desensitization treatment. Participants assigned to both treatments will meet with a
      psychologist once a week for 8 weeks. Participants will learn new sleeping habits and mental
      exercises designed to reduce arousal and alertness while trying to sleep. All participants
      will attend four assessment visits over the course of Phase 2. The first visit will occur at
      Week 4 and will include completing questionnaires and undergoing pain testing. The second
      visit will occur at Week 8 and will include the same questionnaires, further pain testing
      with optional blood draws and physical tests and an in-home sleep study. Two weeks before
      assessment Visit 3, participants will receive a diary in the mail, which they will use to
      keep track of their pain, sleep, medications, and symptoms until Visit 3. Assessment Visit 3
      will take place at Month 5 and will include the same procedures followed during Visit 2.
      Participants will complete a second diary 2 weeks before Visit 4. At Visit 4, which will
      occur at Month 8, the same procedures completed at Visits 2 and 3 will be repeated.
    

Intervention name(s): Cognitive behavioral therapy (CBT) for insomnia; Behavioral desensitization treatment for insomnia
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): CBT-I
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Insomnia; Knee pain; Osteoarthritis; Arthritis; Sleep