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

• ClinicalTrials.gov Identifier: NCT01142349
• Recruitment Status: Completed
• First Posted: June 11, 2010
• Last Update Posted: December 19, 2013
• Sponsor: University of Washington
• Collaborator: Kaiser Permanente
• Information provided by (Responsible Party): Michael Vitiello, University of Washington

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pain Dysfunction; Sleep Disturbance; Osteoarthritis	Behavioral: Lifestyles A; Behavioral: Lifestyles B; Behavioral: Lifestyles C	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 367 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults
• Study Start Date: January 2009
• Actual Primary Completion Date: August 2013
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Washington

Group Health Research Institute

Seattle, Washington, United States, 98101

University of Washington

Seattle, Washington, United States, 98115

Sponsors and Collaborators

University of Washington

Kaiser Permanente

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:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Michael Vitiello, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT01142349
• Other Study ID Numbers: R01AG031126 ( U.S. NIH Grant/Contract ); R01AG031126 ( U.S. NIH Grant/Contract )
• First Posted: June 11, 2010
• Last Update Posted: December 19, 2013
• Last Verified: December 2013

Keywords provided by Michael Vitiello, 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 Initiation and Maintenance Disorders; Dyssomnias; Parasomnias; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders