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Dual Treatment of Chronic Pain and Insomnia

Primary Purpose

Insomnia, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Interdisciplinary Pain Rehabilitation Program (IPRP)
Sponsored by
Mary Free Bed Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

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

Inclusion Criteria:

  • enrolled in the IPRP
  • has chronic pain
  • Insomnia Severity Index (ISI) score of 8 or greater
  • English-speaking
  • able to provide informed consent
  • 18 years of age or older

Exclusion Criteria:

  • non-English-speaking
  • unable to provide informed consent
  • less than 18 years of age
  • ISI score less than 8
  • not concurrently enrolled in the IPRP

Sites / Locations

  • Mary Free Bed Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPRP + CBT-I

IPRP-UC

Arm Description

Interdisciplinary Pain Rehabilitation Program + Cognitive Behavioral Therapy for Insomnia (IPRP + CBT-I)

Interdisciplinary Pain Rehabilitation Program Usual Care (IPRP-UC)

Outcomes

Primary Outcome Measures

Insomnia severity
Insomnia Severity Index (ISI), a 7-item self-report measure was administered to assess insomnia symptoms at up to 4 time points: 1) IPRP admission (both groups), 2) IPRP discharge (10 weeks later; both groups); 3) CBT-I intervention week 1 (IPRP+CBT-I group only) and CBT-I intervention week 4 (IPRP+CBT-I group only)

Secondary Outcome Measures

Pain severity
Numeric pain scale (0-10 rating) for the time period of the past month was used to assess self-reported pain intensity
Pain interference
Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Interference 8a was administered to assess self-reported pain-related life interference
Depressed mood
Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a was used to assess self-reported depressed mood at the beginning and end of IPRP participation

Full Information

First Posted
August 18, 2021
Last Updated
August 29, 2021
Sponsor
Mary Free Bed Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05033418
Brief Title
Dual Treatment of Chronic Pain and Insomnia
Official Title
Dual Treatment of Chronic Pain and Insomnia Within an Interdisciplinary Pain Rehabilitation Program
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2019 (Actual)
Primary Completion Date
January 28, 2021 (Actual)
Study Completion Date
April 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mary Free Bed Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate a group-based cognitive behavioral therapy for insomnia (CBT-I) intervention delivered in an interdisciplinary pain rehabilitation program (IPRP) compared to usual care.
Detailed Description
Dual Treatment of Chronic Pain and Insomnia within an Interdisciplinary Pain Rehabilitation Program The aim of this project is to develop a dual treatment model for chronic pain and insomnia by combining evidence-based approaches for each condition, addressing an important gap in the research on and treatment of chronic pain. Insomnia is frequently comorbid among patients with chronic pain. Estimates suggest that 50-80% of patients receiving treatment for chronic pain also report significant insomnia. Patients with comorbid insomnia and chronic pain are at higher risk of negative outcomes compared to individuals without insomnia. More specifically, studies have found that higher levels of insomnia are associated with increased difficulty in reducing opioid use, higher pain intensity, greater functional limitations, lower self-efficacy, higher pain catastrophizing, and more depressive symptoms compared to patients with less severe insomnia. Importantly, for patients with clinically significant insomnia symptoms, insomnia often does not improve to a meaningful extent as a result of chronic pain treatment alone. Accordingly, there is a significant need for dual treatment models that address both chronic pain and insomnia. Cognitive-Behavioral Therapy for Insomnia (CBT-I) CBT-I is viewed as the "gold standard" treatment for clinical insomnia. In this treatment model, insomnia is viewed as originating from varying precipitating events (e.g., illness, life changes, pain symptoms), but maintained through sleep-related behaviors that increase sleep-related arousal, fragment sleep, and condition an association between bed/nighttime and wakefulness. Accordingly, CBT-I uses conditioning principles to decrease pre-sleep arousal and recondition a pattern of rapid, consolidated sleep. The key components of this intervention are sleep restriction therapy (SRT), which limits time in bed initially to the duration of actual sleep per night, and stimulus control (SC), which involves modification of factors that associate bed/nighttime with wakefulness (e.g., time awake in bed, wakeful activities in bed). Several randomized controlled trials (RCTs) have been conducted to evaluate this treatment among patients with insomnia and a variety of comorbid chronic pain conditions.8 When compared to usual care or a waiting list control group, patients assigned to receive CBT-I have reported significantly better improvements in insomnia symptoms. In addition, results indicate that the effects of CBT-I delivered to patients with chronic pain have been maintained or improved over time. Interdisciplinary Pain Rehabilitation and Outcomes for Chronic Pain and Insomnia Interdisciplinary pain rehabilitation programs (IPRPs) are evidence-based treatments for chronic pain. These programs emphasize functional restoration and typically involve physical and occupational therapy, medical visits, and mental health visits. Although these programs typically include sleep hygiene training, research indicates that while patients experience significant gains in improving pain, functioning, and quality of life, IPRPs alone are insufficient for improving clinical insomnia. Hybrid interventions for pain and insomnia have demonstrated successful outcomes for treating sleep disturbance and chronic pain. However, the incorporation of CBT-I into and IPRP has not been previously studied. This gap in research has been previously documented and represents an important area for future study. The Current Study The current study aims to assess the effectiveness of CBT-I within the context of a 10-week outpatient IPRP and evaluate whether participation leads to superior outcomes compared to pain rehabilitation alone. Hypothesis 1: Insomnia severity will be associated with pain-related outcomes among patients presenting for chronic pain treatment. Hypothesis 2: CBT-I participation will be associated with significant improvement in insomnia symptoms. Hypothesis 3: Compared to a waitlist control group, patients who participate in CBT-I will have superior treatment outcomes from a pain rehabilitation program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Chronic Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
IPRP + CBT-I
Arm Type
Experimental
Arm Description
Interdisciplinary Pain Rehabilitation Program + Cognitive Behavioral Therapy for Insomnia (IPRP + CBT-I)
Arm Title
IPRP-UC
Arm Type
Active Comparator
Arm Description
Interdisciplinary Pain Rehabilitation Program Usual Care (IPRP-UC)
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
4-session CBT-I group in addition to IPRP
Intervention Type
Behavioral
Intervention Name(s)
Interdisciplinary Pain Rehabilitation Program (IPRP)
Intervention Description
10-week IPRP usual care
Primary Outcome Measure Information:
Title
Insomnia severity
Description
Insomnia Severity Index (ISI), a 7-item self-report measure was administered to assess insomnia symptoms at up to 4 time points: 1) IPRP admission (both groups), 2) IPRP discharge (10 weeks later; both groups); 3) CBT-I intervention week 1 (IPRP+CBT-I group only) and CBT-I intervention week 4 (IPRP+CBT-I group only)
Time Frame
pre- and post-CBT-I intervention (group intervention weeks 1 and 4); pre- and post-IPRP intervention (IPRP weeks 0 and 10)
Secondary Outcome Measure Information:
Title
Pain severity
Description
Numeric pain scale (0-10 rating) for the time period of the past month was used to assess self-reported pain intensity
Time Frame
pre- and post-IPRP intervention (weeks 0 and 10)
Title
Pain interference
Description
Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Interference 8a was administered to assess self-reported pain-related life interference
Time Frame
pre- and post-IPRP intervention (weeks 0 and 10)
Title
Depressed mood
Description
Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a was used to assess self-reported depressed mood at the beginning and end of IPRP participation
Time Frame
pre- and post-IPRP intervention (weeks 0 and 10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: enrolled in the IPRP has chronic pain Insomnia Severity Index (ISI) score of 8 or greater English-speaking able to provide informed consent 18 years of age or older Exclusion Criteria: non-English-speaking unable to provide informed consent less than 18 years of age ISI score less than 8 not concurrently enrolled in the IPRP
Facility Information:
Facility Name
Mary Free Bed Rehabilitation Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Dual Treatment of Chronic Pain and Insomnia

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