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Treatment of Insomnia Secondary to Chronic Pain

Primary Purpose

Insomnia, Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT for Insomnia (CBT-I)
CBT for Pain (CBT-P)
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Sleep, Pain, Pain, Chronic, Behavior Therapy, CBT, CBT-I, cognitive-behavioral

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ages 35-75 Chronic non-malignant painful condition of the spine of > 6 months duration Insomnia (> 30 minutes sleep latency and/or wake after sleep onset time for > 3 days/week for > 6 months) Insomnia developed after the onset of the painful condition Preferred sleep phase between 10:00 p.m. and 8:00 am On stable medical regimen for medical and pain conditions (no surgery planned) Willingness to discontinue hypnotic medications Exclusion Criteria: Unstable medical or psychiatric illness History of seizures Evidence of active illicit substance use or fitting criteria for ethanol (ETOH) abuse or dependence Symptoms suggestive of sleep disorders other than insomnia Polysomnographic data indicating sleep disorders other than insomnia Inadequate language comprehension Fibromyalgia Pregnancy

Sites / Locations

  • University of Rochester Sleep Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

No Intervention

Arm Label

CBT for Insomnia (CBT-I)

CBT for Pain (CBT-P)

CBT for Insomnia & Pain (CBT-I/P)

Wait-List Control (WL)

Arm Description

Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.

Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.

Combined Cognitive-Behavioral Therapy for Insomnia & Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions.

Waitlist Control condition (WL) with no contact during the intervention period.

Outcomes

Primary Outcome Measures

Insomnia Severity
Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
Pain Severity
Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.
IL-6
Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.

Secondary Outcome Measures

Depression Severity
Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.

Full Information

First Posted
August 3, 2005
Last Updated
September 14, 2012
Sponsor
University of Rochester
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00127790
Brief Title
Treatment of Insomnia Secondary to Chronic Pain
Official Title
CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Several studies have shown that behavioral therapy for chronic pain can be beneficial for chronic pain and that behavioral therapy for insomnia can be beneficial for insomnia. However, seldom do chronic pain patients with insomnia receive a behavioral treatment for insomnia. The purpose of this study is to evaluate whether treatment for insomnia is helpful for pain and whether treatment for pain is helpful for insomnia. It will also assess whether a combined treatment is any more or less effective for pain or for sleep. Finally, the study will assess whether any of these treatments leads to improvements in immune function.
Detailed Description
The investigators' primary goal is to assess the extent to which three forms of cognitive-behavioral treatment (CBT for insomnia, CBT for pain, and combined insomnia & pain) diminishes insomnia symptoms in patients with chronic pain compared to a group not receiving CBT. This will be evaluated in a randomized trial with before and after evaluations using standard sleep diary measures of sleep continuity. The investigators' secondary goal is to assess whether treatment responses to any of the interventions are associated with alterations in immune function. The investigators' tertiary goals are to evaluate whether improved sleep has effects on patient reports of pain severity, frequency, and tolerability as well as on mood and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Pain
Keywords
Insomnia, Sleep, Pain, Pain, Chronic, Behavior Therapy, CBT, CBT-I, cognitive-behavioral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for Insomnia (CBT-I)
Arm Type
Active Comparator
Arm Description
Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
Arm Title
CBT for Pain (CBT-P)
Arm Type
Active Comparator
Arm Description
Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
Arm Title
CBT for Insomnia & Pain (CBT-I/P)
Arm Type
Experimental
Arm Description
Combined Cognitive-Behavioral Therapy for Insomnia & Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions.
Arm Title
Wait-List Control (WL)
Arm Type
No Intervention
Arm Description
Waitlist Control condition (WL) with no contact during the intervention period.
Intervention Type
Behavioral
Intervention Name(s)
CBT for Insomnia (CBT-I)
Other Intervention Name(s)
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Intervention Type
Behavioral
Intervention Name(s)
CBT for Pain (CBT-P)
Other Intervention Name(s)
Cognitive-Behavioral Therapy for Pain (CBT-P)
Primary Outcome Measure Information:
Title
Insomnia Severity
Description
Total Score from the 7-item Insomnia Severity Index where total score ranges from 0-28 and higher scores indicate greater severity of insomnia.
Time Frame
Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Title
Pain Severity
Description
Multidimensional Pain Inventory - Pain Severity SubScale score. The subscale consists of 3 items with a total subscale score ranging from 0-18 with higher values indicating greater pain severity.
Time Frame
Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Title
IL-6
Description
Circulating levels of Interleukin-6 (IL-6)from plasma drawn in the morning. Values are presented as picograms per milliliter (pg/mL) and can range from 0 to 500, though tend to be in the range of 0-10. Higher values indicate higher amounts of circulating levels of IL-6, a marker of increased inflammatory processes.
Time Frame
Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Secondary Outcome Measure Information:
Title
Depression Severity
Description
Total score from the 20-item Center for Epidemiologic Studies Depression Scale-revised where the total score ranges from 0-60 and higher scores indicate greater depression severity.
Time Frame
Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 35-75 Chronic non-malignant painful condition of the spine of > 6 months duration Insomnia (> 30 minutes sleep latency and/or wake after sleep onset time for > 3 days/week for > 6 months) Insomnia developed after the onset of the painful condition Preferred sleep phase between 10:00 p.m. and 8:00 am On stable medical regimen for medical and pain conditions (no surgery planned) Willingness to discontinue hypnotic medications Exclusion Criteria: Unstable medical or psychiatric illness History of seizures Evidence of active illicit substance use or fitting criteria for ethanol (ETOH) abuse or dependence Symptoms suggestive of sleep disorders other than insomnia Polysomnographic data indicating sleep disorders other than insomnia Inadequate language comprehension Fibromyalgia Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilfred R. Pigeon, Ph.D
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Sleep Research Laboratory
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Treatment of Insomnia Secondary to Chronic Pain

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