Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

Osteoarthritis Clinical Trial

— Lifestyles  

Official title:

Cognitive Behavioral Therapy for Arthritis Pain and Insomnia in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142349
• Other study ID #: R01AG031126
• Secondary ID: R01AG031126
• Status: Completed
• Phase: N/A
• First received: May 26, 2010
• Last updated: December 17, 2013
• Start date: January 2009
• Est. completion date: August 2013

Study information

• Verified date: December 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 symptoms than will the other two treatments.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 367
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyssomnias
• Osteoarthritis
• Pain Dysfunction
• Parasomnias
• Sleep Disorders
• Sleep Disturbance

Intervention

Behavioral:
• Lifestyles A
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain and insomnia
• Lifestyles B
Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.
• Lifestyles C
Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.

Locations

Country	Name	City	State
United States	Group Health Research Institute	Seattle	Washington
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Group Health Cooperative

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

Montgomery P, Dennis J. Cognitive behavioural interventions for sleep problems in adults aged 60+. Cochrane Database Syst Rev. 2002;(2):CD003161. Review. Update in: Cochrane Database Syst Rev. 2003;(1):CD003161. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline	No
Primary	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).	Post treatment- 2 months post baseline assessment	No
Primary	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).	9 months post baseline assessment	No
Primary	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).	18 months post baseline assessment	No
Primary	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).	Baseline	No
Primary	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).	Post treatment-2 mos. post baseline	No
Primary	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).	9 months post baseline assessment	No
Primary	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).	18 months post baseline assessment	No