InsomniaNCT00127790
Treatment of Insomnia Secondary to Chronic Pain
A study testing CBT for Insomnia (CBT-I) and CBT for Pain (CBT-P) in people with Insomnia and Pain, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- What is being tested?
- CBT for Insomnia (CBT-I) and CBT for Pain (CBT-P)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Nov 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Sleep Research Laboratory
Rochester, New York, 14642
About this study
Official title: CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
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.
Read the 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.
- Being tested
- CBT for Insomnia (CBT-I), CBT for Pain (CBT-P)
- Keywords
- Insomnia, Sleep, Pain, Pain, Chronic, Behavior Therapy, CBT, CBT-I, cognitive-behavioral
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for Insomnia (CBT-I)Behavioural
Also called Cognitive-Behavioral Therapy for Insomnia (CBT-I)
CBT for Pain (CBT-P)Behavioural
Also called Cognitive-Behavioral Therapy for Pain (CBT-P)
| Study group | Role | What they receive |
|---|---|---|
| CBT for Insomnia (CBT-I) | Active comparator | 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. Receives: Behavioral: CBT for Insomnia (CBT-I) |
| CBT for Pain (CBT-P) | Active comparator | 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. Receives: Behavioral: CBT for Pain (CBT-P) |
| CBT for Insomnia & Pain (CBT-I/P) | Experimental | Combined Cognitive-Behavioral Therapy for Insomnia \& Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions. Receives: Behavioral: CBT for Insomnia (CBT-I); Behavioral: CBT for Pain (CBT-P) |
| Wait-List Control (WL) | No intervention | Waitlist Control condition (WL) with no contact during the intervention period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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.
Measured: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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.
Measured: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
Secondary outcomes (1)
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.
Measured: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionOct 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Wilfred Pigeon, University of Rochester
- Investigators
- Wilfred R. Pigeon, Ph.D, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127790
- Sponsor's protocol ID
- 160743209
- Other IDs
- F32NS049789, K23NR010408, R21AG023956; R24AG031089, R21AG023956
- Status last verified
- Sep 2012
- First submitted
- 3 Aug 2005
- Last updated
- 17 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT for Co-Morbid Insomnia and Chronic Pain: Sleep, Pain and Immune Function Outcomes
- ClinicalTrials.gov ID
- NCT00127790
- Acronym / sponsor ID
- 160743209
- Keywords
- Insomnia, Sleep, Pain, Pain, Chronic, Behavior Therapy, CBT, CBT-I, cognitive-behavioral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Jun 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 8 Aug 2005 (estimated)
- Results
- Posted 17 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBT for Insomnia (CBT-I) | Active comparator | Behavioral: CBT for Insomnia (CBT-I)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. |
| CBT for Pain (CBT-P) | Active comparator | Behavioral: CBT for Pain (CBT-P)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. |
| CBT for Insomnia & Pain (CBT-I/P) | Experimental | Behavioral: CBT for Insomnia (CBT-I), Behavioral: CBT for Pain (CBT-P)Combined Cognitive-Behavioral Therapy for Insomnia \& Cognitive-Behavioral Therapy for Pain (CBT-I/P)over 10 individual sessions. |
| Wait-List Control (WL) | No intervention | –Waitlist Control condition (WL) with no contact during the intervention period. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| CBT for Insomnia (CBT-I)Also: Cognitive-Behavioral Therapy for Insomnia (CBT-I) | Behavioural | CBT for Insomnia & Pain (CBT-I/P), CBT for Insomnia (CBT-I) |
| CBT for Pain (CBT-P)Also: Cognitive-Behavioral Therapy for Pain (CBT-P) | Behavioural | CBT for Insomnia & Pain (CBT-I/P), CBT for Pain (CBT-P) |
Primary outcome
Insomnia Severity
Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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
Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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
Time frame: Pre to Post Treatment Change (Over an average of approximately 10 weeks)
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.
1 secondary outcome
Depression Severity
Time frame: Pre to Post Treatment Chnage (Over an average of approximately 10 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Wilfred R. Pigeon, Ph.D principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for Insomnia (CBT-I) and CBT for Pain (CBT-P) in people with Insomnia and Pain, run by University of Rochester 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 7 inclusion and 8 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 17 Oct 2012. 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?
Yes. Results are posted in the registry (first posted 17 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 to Post Treatment Change (Over an average of approximately 10 weeks)). The study lists 3 primary outcomes in all. 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 17 Oct 2012.