Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05033418 |
| Other study ID # |
2019.10 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 6, 2019 |
| Est. completion date |
April 27, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Mary Free Bed Rehabilitation Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
