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
  Purpose

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.


Condition Intervention
Pain Dysfunction
Sleep Disturbance
Osteoarthritis
Behavioral: Lifestyles A
Behavioral: Lifestyles B
Behavioral: Lifestyles C

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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).


Enrollment: 367
Study Start Date: January 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lifestyles A
Cognitive Behavioral Therapy for Pain and Insomnia
Behavioral: Lifestyles A
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain and insomnia
Experimental: Lifestyle B
Cognitive Behavioral Therapy for Pain
Behavioral: Lifestyles B
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.
Active Comparator: Lifestyles C
Osteoarthritis Education
Behavioral: Lifestyles C
Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.

Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142349

Locations
United States, Washington
University of Washington
Seattle, Washington, United States, 98115
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
University of Washington
Group Health Cooperative
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Vitiello, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01142349     History of Changes
Other Study ID Numbers: R01-AG031126, R01-AG031126
Study First Received: May 26, 2010
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Arthritis
Group Program
Pain
Insomnia
Pain dysfunction and sleep disturbance among older adults with osteoarthritis.

Additional relevant MeSH terms:
Arthritis
Osteoarthritis
Sleep Disorders
Dyssomnias
Parasomnias
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on July 24, 2014