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Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

NCT ID: NCT01142349

Last Updated: 2013-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

367 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Dysfunction Sleep Disturbance Osteoarthritis

Keywords

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Arthritis Group Program Pain Insomnia Pain dysfunction and sleep disturbance among older adults with osteoarthritis.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Lifestyles A

Cognitive Behavioral Therapy for Pain and Insomnia

Group Type EXPERIMENTAL

Lifestyles A

Intervention Type BEHAVIORAL

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

Lifestyle B

Cognitive Behavioral Therapy for Pain

Group Type EXPERIMENTAL

Lifestyles B

Intervention Type BEHAVIORAL

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

Lifestyles C

Osteoarthritis Education

Group Type ACTIVE_COMPARATOR

Lifestyles C

Intervention Type BEHAVIORAL

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

Interventions

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Lifestyles A

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

Intervention Type BEHAVIORAL

Lifestyles B

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

Intervention Type BEHAVIORAL

Lifestyles C

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaiser Permanente

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Michael Vitiello

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael V Vitiello, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Susan M McCurry, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Michael Von Korff, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

Group Health Research Institute

Ben Balderson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Group Health Research Institute

Locations

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Group Health Research Institute

Seattle, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 15033151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17520794 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1895046 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16392989 (View on PubMed)

Montgomery P, Dennis J. Cognitive behavioural interventions for sleep problems in adults aged 60+. Cochrane Database Syst Rev. 2002;2003(2):CD003161. doi: 10.1002/14651858.CD003161.

Reference Type BACKGROUND
PMID: 12076472 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33910159 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24793909 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24497658 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23711168 (View on PubMed)

Other Identifiers

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R01AG031126

Identifier Type: NIH

Identifier Source: secondary_id

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R01AG031126

Identifier Type: NIH

Identifier Source: org_study_id

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