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Completed

NCT Number: NCT01142349

Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

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.

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Key information

Conditions

Pain Dysfunction Arthritis Dyssomnias Joint Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Osteoarthritis Pain Parasomnias Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Disturbance Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Group Health Research Institute, Seattle, Washington, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyles A

Behavioral

Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain and insomnia

Lifestyles B

Behavioral

Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.

Lifestyles C

Behavioral

Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: Baseline

    A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).

  2. Insomnia Severity Index (ISI)

    Time frame: Post treatment- 2 months post baseline assessment

    A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).

  3. Insomnia Severity Index (ISI)

    Time frame: 9 months post baseline assessment

    A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).

  4. Insomnia Severity Index (ISI)

    Time frame: 18 months post baseline assessment

    A 7-item self-report screening measure that rates severity of sleep problems, interference with daily functioning, and participant distress over symptoms. Rated on a scale from 0 (no problems) to 4 (very much a problem).

  5. Global Pain Severity-Graded Chronic Pain Scale

    Time frame: Baseline

    The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).

  6. Global Pain Severity-Graded Chronic Pain Scale

    Time frame: Post treatment-2 mos. post baseline

    The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).

  7. Global Pain Severity-Graded Chronic Pain Scale

    Time frame: 9 months post baseline assessment

    The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).

  8. Global Pain Severity- Graded Chronic Pain Scale

    Time frame: 18 months post baseline assessment

    The Global Pain Severity Scale derived from the Graded Chronic Pain Scale consists of three 0-10 pain intensity ratings (pain right now, average pain, and worst pain in the prior month) and three 0-10 pain interference ratings (interference with daily activities, recreational, social and family activites, and ability to work including housework).

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Kaiser Permanente

Registry information

Acronym: Lifestyles

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2010
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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