Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults (Lifestyles)
December 17, 2013 updated by: Michael Vitiello, University of Washington
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
367
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98101
- Group Health Research Institute
-
Seattle, Washington, United States, 98115
- University of Washington
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyles A
Cognitive Behavioral Therapy for Pain and Insomnia
|
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
|
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.
|
|
Active Comparator: Lifestyles C
Osteoarthritis Education
|
Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline
|
|
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).
|
Post treatment- 2 months post baseline assessment
|
|
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).
|
9 months post baseline assessment
|
|
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).
|
18 months post baseline assessment
|
|
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).
|
Baseline
|
|
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).
|
Post treatment-2 mos. post baseline
|
|
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).
|
9 months post baseline assessment
|
|
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).
|
18 months post baseline assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan M McCurry, Ph.D., University of Washington
- Principal Investigator: Michael V Vitiello, 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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Smith MT, Haythornthwaite JA. How do sleep disturbance and chronic pain inter-relate? Insights from the longitudinal and cognitive-behavioral clinical trials literature. Sleep Med Rev. 2004 Apr;8(2):119-32. doi: 10.1016/S1087-0792(03)00044-3.
- Smith MT, Edwards RR, McCann UD, Haythornthwaite JA. The effects of sleep deprivation on pain inhibition and spontaneous pain in women. Sleep. 2007 Apr;30(4):494-505. doi: 10.1093/sleep/30.4.494.
- Moffitt PF, Kalucy EC, Kalucy RS, Baum FE, Cooke RD. Sleep difficulties, pain and other correlates. J Intern Med. 1991 Sep;230(3):245-9. doi: 10.1111/j.1365-2796.1991.tb00438.x.
- Rybarczyk B, Stepanski E, Fogg L, Lopez M, Barry P, Davis A. A placebo-controlled test of cognitive-behavioral therapy for comorbid insomnia in older adults. J Consult Clin Psychol. 2005 Dec;73(6):1164-74. doi: 10.1037/0022-006X.73.6.1164.
- Montgomery P, Dennis J. Cognitive behavioural interventions for sleep problems in adults aged 60+. Cochrane Database Syst Rev. 2002;(2):CD003161. doi: 10.1002/14651858.CD003161.
- Thakral M, Von Korff M, McCurry SM, Morin CM, Vitiello MV. ISI-3: evaluation of a brief screening tool for insomnia. Sleep Med. 2021 Jun;82:104-109. doi: 10.1016/j.sleep.2020.08.027. Epub 2020 Aug 27.
- Vitiello MV, McCurry SM, Shortreed SM, Baker LD, Rybarczyk BD, Keefe FJ, Von Korff M. Short-term improvement in insomnia symptoms predicts long-term improvements in sleep, pain, and fatigue in older adults with comorbid osteoarthritis and insomnia. Pain. 2014 Aug;155(8):1547-1554. doi: 10.1016/j.pain.2014.04.032. Epub 2014 May 1.
- McCurry SM, Shortreed SM, Von Korff M, Balderson BH, Baker LD, Rybarczyk BD, Vitiello MV. Who benefits from CBT for insomnia in primary care? Important patient selection and trial design lessons from longitudinal results of the Lifestyles trial. Sleep. 2014 Feb 1;37(2):299-308. doi: 10.5665/sleep.3402.
- Vitiello MV, McCurry SM, Shortreed SM, Balderson BH, Baker LD, Keefe FJ, Rybarczyk BD, Von Korff M. Cognitive-behavioral treatment for comorbid insomnia and osteoarthritis pain in primary care: the lifestyles randomized controlled trial. J Am Geriatr Soc. 2013 Jun;61(6):947-956. doi: 10.1111/jgs.12275. Epub 2013 May 27.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
May 26, 2010
First Submitted That Met QC Criteria
June 10, 2010
First Posted (Estimate)
June 11, 2010
Study Record Updates
Last Update Posted (Estimate)
December 19, 2013
Last Update Submitted That Met QC Criteria
December 17, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AG031126 (U.S. NIH Grant/Contract)
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