InsomniaNCT05033418
Dual Treatment of Chronic Pain and Insomnia
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Interdisciplinary Pain Rehabilitation Program (IPRP) in people with Insomnia and Chronic Pain, run by Mary Free Bed Rehabilitation Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Chronic Pain
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I) and Interdisciplinary Pain Rehabilitation Program (IPRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2019to 27 Apr 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary Free Bed Rehabilitation Hospital
Grand Rapids, Michigan, 49503
About this study
Official title: Dual Treatment of Chronic Pain and Insomnia Within an Interdisciplinary Pain Rehabilitation Program
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.
Read the 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.
- Conditions
- Insomnia, Chronic Pain
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Interdisciplinary Pain Rehabilitation Program (IPRP)
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
4-session CBT-I group in addition to IPRP
Interdisciplinary Pain Rehabilitation Program (IPRP)Behavioural
10-week IPRP usual care
| Study group | Role | What they receive |
|---|---|---|
| IPRP + CBT-I | Experimental | Interdisciplinary Pain Rehabilitation Program + Cognitive Behavioral Therapy for Insomnia (IPRP + CBT-I) Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I); Behavioral: Interdisciplinary Pain Rehabilitation Program (IPRP) |
| IPRP-UC | Active comparator | Interdisciplinary Pain Rehabilitation Program Usual Care (IPRP-UC) Receives: Behavioral: Interdisciplinary Pain Rehabilitation Program (IPRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: pre- and post-CBT-I intervention (group intervention weeks 1 and 4); pre- and post-IPRP intervention (IPRP weeks 0 and 10)
Secondary outcomes (3)
Pain severity
Numeric pain scale (0-10 rating) for the time period of the past month was used to assess self-reported pain intensity
Measured: pre- and post-IPRP intervention (weeks 0 and 10)
Pain interference
Patient Reported Outcomes Measurement Information System (PROMIS)-Pain Interference 8a was administered to assess self-reported pain-related life interference
Measured: pre- and post-IPRP intervention (weeks 0 and 10)
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
Measured: pre- and post-IPRP intervention (weeks 0 and 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start6 Jun 2019
- Primary completion28 Jan 2021
- Study completion27 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mary Free Bed Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Craner Cooper, Mary Free Bed Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033418
- Sponsor's protocol ID
- 2019.10
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Treatment of Chronic Pain and Insomnia Within an Interdisciplinary Pain Rehabilitation Program
- ClinicalTrials.gov ID
- NCT05033418
- Acronym / sponsor ID
- 2019.10
- Conditions
- Insomnia, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Mary Free Bed Rehabilitation HospitalUniversity, hospital or other
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 28 Jan 2021 (actual)
- Study completion
- 27 Apr 2021 (actual)
- First posted
- 2 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPRP + CBT-I | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I), Behavioral: Interdisciplinary Pain Rehabilitation Program (IPRP)Interdisciplinary Pain Rehabilitation Program + Cognitive Behavioral Therapy for Insomnia (IPRP + CBT-I) |
| IPRP-UC | Active comparator | Behavioral: Interdisciplinary Pain Rehabilitation Program (IPRP)Interdisciplinary Pain Rehabilitation Program Usual Care (IPRP-UC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- enrolled in the IPRP
- has chronic pain
- Insomnia Severity Index (ISI) score of 8 or greater
- English-speaking
- able to provide informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I)4-session CBT-I group in addition to IPRP | Behavioural | IPRP + CBT-I |
| Interdisciplinary Pain Rehabilitation Program (IPRP)10-week IPRP usual care | Behavioural | IPRP + CBT-I, IPRP-UC |
Primary outcome
Insomnia severity
Time frame: pre- and post-CBT-I intervention (group intervention weeks 1 and 4); pre- and post-IPRP intervention (IPRP weeks 0 and 10)
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)
3 secondary outcomes
Pain severity
Time frame: pre- and post-IPRP intervention (weeks 0 and 10)
Pain interference
Time frame: pre- and post-IPRP intervention (weeks 0 and 10)
Depressed mood
Time frame: pre- and post-IPRP intervention (weeks 0 and 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Interdisciplinary Pain Rehabilitation Program (IPRP) in people with Insomnia and Chronic Pain, run by Mary Free Bed Rehabilitation Hospital at 1 site 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 6 inclusion and 5 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (time frame: pre- and post-CBT-I intervention (group intervention weeks 1 and 4); pre- and post-IPRP intervention (IPRP weeks 0 and 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2021.