Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults (Lifestyles)

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University of Washington

Status

Completed

Conditions

Osteoarthritis
Sleep Disturbance
Pain Dysfunction

Treatments

Behavioral: Lifestyles B
Behavioral: Lifestyles A
Behavioral: Lifestyles C

Study type

Interventional

Funder types

Other

Identifiers

NCT01142349
R01AG031126 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study compares the efficacy of three group interventions for people with co-morbid osteoarthritis (OA) and insomnia to help them manage their OA symptoms. The investigators hypothesize that a combination cognitive-behavioral treatment will produce significantly greater initial and long-term improvements in OA symptoms than will the other two treatments.

Full description

This study is only for members of the Group Health Cooperative (GHC) of Puget Sound who have both osteoarthritis pain and insomnia. The first part of the study involves filling out a mailed survey. Based on the results of the survey some respondents will be eligible for the second part of the study. Our goal in the second part is to test three different treatments for managing OA symptoms. The programs teach about things people with arthritis can do to improve the quality of their lives. All three programs deal with pain, sleep, mood and activity-but each has a slightly different focus. Participants will be randomly assigned to one of the three programs. Each program is made up of six weekly group sessions that last about 90-120 minutes. The programs will be co-led by licensed therapists and each will include 8-12 members. Study participants will also take part in a series of visits at their homes over the next 18 months. At each visit the investigators will ask them to do a few other study activities, such as keep a 7-day diary of their sleep and fill out a survey about their arthritis pain. With their permission the investigators will also ask them to let us collect some information from their GHC medical records.

Enrollment

367 patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 60+
  • Continuously enrolled in Group Health one year prior to sample pull
  • Primary care clinic at selected clinics
  • Not in "No Contact File"
  • Diagnosis 715xx (Osteoarthritis) in prior three years

Exclusion criteria

Not continuously enrolled in Group Health for at least one year

Medical record information indicates a diagnosis of:

  • rheumatoid arthritis
  • obstructive sleep apnea
  • periodic leg movement disorder
  • restless leg syndrome
  • sleep-wake cycle disturbance
  • rapid eye movement (REM) behavior disorder
  • dementia or receiving cholinesterase inhibitors
  • Parkinson's disease or other neurodegenerative disease known to directly impact sleep
  • cancer in the past year and receiving chemotherapy or radiation therapy in the past year
  • inpatient treatment for congestive heart failure within the previous 6 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

367 participants in 3 patient groups

Lifestyles A
Experimental group
Description:
Cognitive Behavioral Therapy for Pain and Insomnia
Treatment:
Behavioral: Lifestyles A
Lifestyle B
Experimental group
Description:
Cognitive Behavioral Therapy for Pain
Treatment:
Behavioral: Lifestyles B
Lifestyles C
Active Comparator group
Description:
Osteoarthritis Education
Treatment:
Behavioral: Lifestyles C

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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