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

Primary Purpose

Pain Dysfunction, Sleep Disturbance, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyles A
Lifestyles B
Lifestyles C
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Dysfunction focused on measuring Arthritis, Group Program, Pain, Insomnia, Pain dysfunction and sleep disturbance among older adults with osteoarthritis.

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Group Health Research Institute
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Lifestyles A

Lifestyle B

Lifestyles C

Arm Description

Cognitive Behavioral Therapy for Pain and Insomnia

Cognitive Behavioral Therapy for Pain

Osteoarthritis Education

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)
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)
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)
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)
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
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
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
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
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).

Secondary Outcome Measures

Full Information

First Posted
May 26, 2010
Last Updated
December 17, 2013
Sponsor
University of Washington
Collaborators
Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT01142349
Brief Title
Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults
Acronym
Lifestyles
Official Title
Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Kaiser Permanente

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Dysfunction, Sleep Disturbance, Osteoarthritis
Keywords
Arthritis, Group Program, Pain, Insomnia, Pain dysfunction and sleep disturbance among older adults with osteoarthritis.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
367 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyles A
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy for Pain and Insomnia
Arm Title
Lifestyle B
Arm Type
Experimental
Arm Description
Cognitive Behavioral Therapy for Pain
Arm Title
Lifestyles C
Arm Type
Active Comparator
Arm Description
Osteoarthritis Education
Intervention Type
Behavioral
Intervention Name(s)
Lifestyles A
Intervention Description
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain and insomnia
Intervention Type
Behavioral
Intervention Name(s)
Lifestyles B
Intervention Description
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyles C
Intervention Description
Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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).
Time Frame
Baseline
Title
Insomnia Severity Index (ISI)
Description
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).
Time Frame
Post treatment- 2 months post baseline assessment
Title
Insomnia Severity Index (ISI)
Description
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).
Time Frame
9 months post baseline assessment
Title
Insomnia Severity Index (ISI)
Description
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).
Time Frame
18 months post baseline assessment
Title
Global Pain Severity-Graded Chronic Pain Scale
Description
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).
Time Frame
Baseline
Title
Global Pain Severity-Graded Chronic Pain Scale
Description
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).
Time Frame
Post treatment-2 mos. post baseline
Title
Global Pain Severity-Graded Chronic Pain Scale
Description
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).
Time Frame
9 months post baseline assessment
Title
Global Pain Severity- Graded Chronic Pain Scale
Description
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).
Time Frame
18 months post baseline assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael V Vitiello, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan M McCurry, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Von Korff, Sc.D.
Organizational Affiliation
Group Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ben Balderson, Ph.D.
Organizational Affiliation
Group Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15033151
Citation
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.
Results Reference
background
PubMed Identifier
17520794
Citation
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.
Results Reference
background
PubMed Identifier
1895046
Citation
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.
Results Reference
background
PubMed Identifier
16392989
Citation
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.
Results Reference
background
PubMed Identifier
12076472
Citation
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.
Results Reference
background
PubMed Identifier
33910159
Citation
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.
Results Reference
derived
PubMed Identifier
24793909
Citation
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.
Results Reference
derived
PubMed Identifier
24497658
Citation
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.
Results Reference
derived
PubMed Identifier
23711168
Citation
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.
Results Reference
derived

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Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

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