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Pain DysfunctionLifestylesNCT01142349

Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

A study testing Lifestyles A, Lifestyles B and Lifestyles C in people with Pain Dysfunction and Sleep Disturbance, run by University of Washington at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Lifestyles A, Lifestyles B and Lifestyles C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
367 participants
Where
2 sitesUnited States
Study dates
Jan 2009to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Group Health Research Institute

    Seattle, Washington, 98101

  • University of Washington

    Seattle, Washington, 98115

Other trials in United States

About this study

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.

Read the 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.

Being tested
Lifestyles A, Lifestyles B, Lifestyles C
Keywords
Arthritis, Group Program, Pain, Insomnia, Pain dysfunction and sleep disturbance among older adults with osteoarthritis.
Medical subject headings
Parasomnias, Osteoarthritis, Arthritis, Pain, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyles ABehavioural

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

  • Lifestyles BBehavioural

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

  • Lifestyles CBehavioural

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

Study groups in NCT01142349
Study groupRoleWhat they receive
Lifestyles AExperimentalCognitive Behavioral Therapy for Pain and Insomnia
Receives: Behavioral: Lifestyles A
Lifestyle BExperimentalCognitive Behavioral Therapy for Pain
Receives: Behavioral: Lifestyles B
Lifestyles CActive comparatorOsteoarthritis Education
Receives: Behavioral: Lifestyles C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline

  2. 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).

    Measured: Post treatment- 2 months post baseline assessment

  3. 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).

    Measured: 9 months post baseline assessment

  4. 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).

    Measured: 18 months post baseline assessment

  5. 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).

    Measured: Baseline

  6. 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).

    Measured: Post treatment-2 mos. post baseline

  7. 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).

    Measured: 9 months post baseline assessment

  8. 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).

    Measured: 18 months post baseline assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2010 (estimated)
  2. Study startJan 2009
  3. Primary completionAug 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01142349
Sponsor's protocol ID
R01AG031126
Other IDs
R01AG031126
Acronym
Lifestyles
Status last verified
Dec 2013
First submitted
26 May 2010
Last updated
19 Dec 2013
Results posted
No
Data monitoring committee
No

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.

    PubMed 15033151

  • 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.

    PubMed 17520794

  • 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.

    PubMed 1895046

  • 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.

    PubMed 16392989

  • 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.

    PubMed 12076472

  • 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.

    PubMed 33910159

  • 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.

    PubMed 24793909

  • 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.

    PubMed 24497658

  • 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.

    PubMed 23711168

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyles A, Lifestyles B and Lifestyles C in people with Pain Dysfunction and Sleep Disturbance, run by University of Washington at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01142349, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.

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