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

This study has been completed.
Sponsor:
Collaborator:
Group Health Cooperative
Information provided by (Responsible Party):
Michael Vitiello, University of Washington
ClinicalTrials.gov Identifier:
NCT01142349
First received: May 26, 2010
Last updated: December 17, 2013
Last verified: December 2013

May 26, 2010
December 17, 2013
January 2009
August 2013   (final data collection date for primary outcome measure)
  • Insomnia Severity Index (ISI) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).
  • Insomnia Severity Index (ISI) [ Time Frame: Post treatment- 2 months post baseline assessment ] [ Designated as safety issue: No ]
    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).
  • Insomnia Severity Index (ISI) [ Time Frame: 9 months post baseline assessment ] [ Designated as safety issue: No ]
    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).
  • Insomnia Severity Index (ISI) [ Time Frame: 18 months post baseline assessment ] [ Designated as safety issue: No ]
    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).
  • Global Pain Severity-Graded Chronic Pain Scale [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).
  • Global Pain Severity-Graded Chronic Pain Scale [ Time Frame: Post treatment-2 mos. post baseline ] [ Designated as safety issue: No ]
    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).
  • Global Pain Severity-Graded Chronic Pain Scale [ Time Frame: 9 months post baseline assessment ] [ Designated as safety issue: No ]
    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).
  • Global Pain Severity- Graded Chronic Pain Scale [ Time Frame: 18 months post baseline assessment ] [ Designated as safety issue: No ]
    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).
Same as current
Complete list of historical versions of study NCT01142349 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pain Dysfunction
  • Sleep Disturbance
  • Osteoarthritis
  • Behavioral: Lifestyles A
    Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain and insomnia
  • Behavioral: Lifestyles B
    Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.
  • Behavioral: Lifestyles C
    Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.
  • Experimental: Lifestyles A
    Cognitive Behavioral Therapy for Pain and Insomnia
    Intervention: Behavioral: Lifestyles A
  • Experimental: Lifestyle B
    Cognitive Behavioral Therapy for Pain
    Intervention: Behavioral: Lifestyles B
  • Active Comparator: Lifestyles C
    Osteoarthritis Education
    Intervention: Behavioral: Lifestyles C

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
367
August 2013
August 2013   (final data collection date for primary outcome measure)

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:

    1. rheumatoid arthritis
    2. obstructive sleep apnea
    3. periodic leg movement disorder
    4. restless leg syndrome
    5. sleep-wake cycle disturbance
    6. rapid eye movement (REM) behavior disorder
    7. dementia or receiving cholinesterase inhibitors
    8. Parkinson's disease or other neurodegenerative disease known to directly impact sleep
    9. cancer in the past year and receiving chemotherapy or radiation therapy in the past year
    10. inpatient treatment for congestive heart failure within the previous 6 months
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01142349
R01-AG031126, R01-AG031126
No
Michael Vitiello, University of Washington
University of Washington
Group Health Cooperative
Principal Investigator: Michael V Vitiello, Ph.D. University of Washington
Principal Investigator: Susan M McCurry, Ph.D. University of Washington
Principal Investigator: Michael Von Korff, Sc.D. Group Health Research Institute
Principal Investigator: Ben Balderson, Ph.D. Group Health Research Institute
University of Washington
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP