Sleep Initiation and Maintenance DisordersSOAPNCT00592449
Sleep in Osteoarthritis Project
A study testing Cognitive behavioral therapy (CBT) for insomnia and Behavioral desensitization treatment for insomnia in people with Sleep Initiation and Maintenance Disorders and Osteoarthritis, run by Johns Hopkins University at 1 site in United States.
Trial summary
Osteoarthritis (OA) is one of the most common diseases and one of the leading causes of disability in the world. People with OA frequently experience sleep disturbances, primarily due to pain. Read more about this study
- Who is it for?
- Ages 35 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Osteoarthritis
- What is being tested?
- Cognitive behavioral therapy (CBT) for insomnia and Behavioral desensitization treatment for insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Jan 2014
- 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 35 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all participants:
- Age ≥ 50 ; or 35 ≥ if KOA/Insomnia group
- For participants with knee OA:
- Meets American College of Rheumatology (ACR) criteria for knee OA
- Shows radiographic evidence of Kellgren-Lawrence Grade OA greater than or equal to 1
- Experiences knee pain more than 5 days per week for more than 6 months
Show all 26Show fewer
- Reports at least typical arthritic pain (a score of at least 2 out of 10, with 0 being no pain and 10 being the most extreme pain imaginable)
- Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen must be on a stable dose for at least 1 month prior to study entry
- Not scheduled for arthroplasty or surgery during projected period of study participation
- For participants with insomnia:
- A sleep maintenance insomnia profile is evident both at study entry (based on retrospective reports) and as an average profile from 2 weeks of sleep diaries
- Meets diagnostic criteria for insomnia due to knee OA only or for primary insomnia
- Reports total sleep time less than 6.5 hours
- Middle insomnia symptom frequency of more than 3 nights per week for more than 1 month
- For participants without insomnia:
- Meets research diagnostic criteria for normal sleepers
- Insomnia Severity Index of less than 10
- Epworth Sleepiness score of less than 10
- Pittsburgh Sleep Quality Index score of less than 5
- Wake After Sleep Onset Time is under 30 minutes
- Sleep efficiency percentage is greater than 85%
- Total sleep time is greater than 6.5 hours
- For participants without knee OA and without insomnia:
- Free from any acute pain or injury
- No recent history of chronic pain within 3 years prior to study entry (pain severity report greater than 2 out of 10 more than 2 days per week for 6 months)
- Reports good overall health, with no major medical or psychiatric illness known to disturb sleep or cause pain
Who cannot join
- Sleep disorders other than insomnia (e.g., obstructive sleep apnea, periodic limb movement disorder, etc.)
- Apnea/Hypopnea Index (AHI) of greater than 15
- Significant rheumatologic or painful disorders other than knee OA (including fibromyalgia, rheumatoid arthritis, neuralgia, etc.)
- Any major medical diseases known to impact sleep or cause pain (including chronic obstructive pulmonary disease, diabetes, congestive heart failure, seizure disorder, Raynaud's phenomenon, etc.)
- Dementia or cognitive impairment, defined as Mini Mental State Exam score of less than 24
- Current or recent history of major psychiatric disorders (within 3 months prior to study entry)
Show all 15Show fewer
- History of schizophrenia or bipolar I disorder
- Center for Epidemiologic Studies of Depression Scale (CES-D) greater than or equal to 27 or suicidal ideation
- Current or history of substance abuse (within 6 months prior to study entry)
- Use of antidepressants, antipsychotics, or mood stabilizers more than 3 days per week in the past 2 months- Note: only applies to groups other than KOA/Insomnia
- Use of narcotics (opioids), myorelaxants, sedatives, or anticonvulsants more than 3 days per week within 1 month prior to study entry
- Unwilling or unable to discontinue all use of certain medications by 1 week prior to study entry
- Refuses to contact physician to obtain relevant medical record information
- Pregnancy or plans to become pregnant within 6 months
- Positive toxicology test (benzodiazepines and receptor agonists, barbiturates, opioids, tetrahydrocannabinol, alcohol, and stimulants)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center 5510 Nathan Shock Dr, Ste 100
Baltimore, Maryland, 21224
About this study
Official title: Sleep Disturbance, Central Pain Modulation, and Clinical Pain in Osteoarthritis (The SOAP Study)
Osteoarthritis (OA) is one of the most common diseases and one of the leading causes of disability in the world. People with OA frequently experience sleep disturbances, primarily due to pain. Although insomnia is a known consequence of OA, recent studies have shown that it may also worsen clinical pain by interfering with the body's responses to painful stimuli. This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA. The study will test whether improvement in clinical pain are mediated by changes in certain types of pain processing.
Read the detailed description
Sleep disturbance and pain are two of the most common and disabling symptoms of OA. Sleep disturbances have been shown to worsen clinical pain by impairing some of the body's central pain processing mechanisms. Sufficient research is lacking, however, on what treatments may be effective for sleep disturbance in people with OA or whether normalization of sleep patterns in people with OA will reduce their pain. This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA.
Participants in Phase 1 of this study will be separated into the following four groups: people with OA and insomnia; people with OA, but without insomnia; people without OA, but with insomnia; and people without OA or insomnia. All participants will attend two study visits. During Visit 1, participants will complete questionnaires and an interview and will provide a urine sample and a set of recent x-rays. A diary, which will be used to record activity levels for 2 weeks, will also be given to all participants.
Optional Ancillary Sleep and Immunoreactivity Study Procedures
Subjects who pass the visit one screen will be provided the option of participating in ancillary study procedures designed to assess inflammatory biomarkers present in plasma, physical functioning capabilities, and pain and mood status during the pain testing procedures. Subjects will be asked to give blood samples during the pain testing procedures, followed by standardized tests of physical function. Subjects will be also asked to complete additional questionnaire and diary items that ask them to rate their emotions during the pain testing procedures and during the days that they keep their electronic diary for the parent project. At Visit 2, participants will undergo pain testing, an in-home sleep study and optional procedures outlined above. At Visit 3, participants with knee osteoarthritis will have an exam by a rheumatologist.
Participants in Phase 1 who have both knee OA and insomnia will be asked to continue into Phase 2, which will last 8 months. These participants will be randomly assigned to receive two different forms of behavioral treatment, cognitive behavior therapy (CBT) or a behavioral desensitization treatment. Participants assigned to both treatments will meet with a psychologist once a week for 8 weeks. Participants will learn new sleeping habits and mental exercises designed to reduce arousal and alertness while trying to sleep. All participants will attend four assessment visits over the course of Phase 2. The first visit will occur at Week 4 and will include completing questionnaires and undergoing pain testing. The second visit will occur at Week 8 and will include the same questionnaires, further pain testing with optional blood draws and physical tests and an in-home sleep study. Two weeks before assessment Visit 3, participants will receive a diary in the mail, which they will use to keep track of their pain, sleep, medications, and symptoms until Visit 3. Assessment Visit 3 will take place at Month 5 and will include the same procedures followed during Visit 2. Participants will complete a second diary 2 weeks before Visit 4. At Visit 4, which will occur at Month 8, the same procedures completed at Visits 2 and 3 will be repeated.
- Being tested
- Cognitive behavioral therapy (CBT) for insomnia, Behavioral desensitization treatment for insomnia
- Keywords
- Insomnia, Knee pain, Osteoarthritis, Arthritis, Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT) for insomniaBehavioural
Also called CBT-I
During CBT, participants will learn how to change their sleeping habits and reduce arousal and alertness while trying to sleep. Participants will attend 8 weekly CBT sessions with a psychologist.
Behavioral desensitization treatment for insomniaBehavioural
The behavioral desensitization treatment is designed to decondition states of arousal that interfere with sleep. Participants will attend 8 weekly behavioral desensitization treatment sessions with a psychologist.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Participants with knee OA who meet research diagnostic criteria for insomnia will partake in Phase 1 |
| 2 | No intervention | Participants with knee OA who meet research diagnostic criteria for normal sleep will partake in Phase 1 |
| 3 | No intervention | Participants without knee OA or a pain syndrome who meet research diagnostic criteria for primary insomnia will partake in Phase 1 |
| 4 | No intervention | Participants without knee OA or a pain syndrome who meet research diagnostic criteria for normal sleep will enroll in Phase I |
| 5 | Experimental | Phase 1 participants with knee OA who meet research diagnostic criteria for insomnia will enroll in Phase 2 of the study and are assigned to receive behavioral desensitization treatment for insomnia Receives: Behavioral: Behavioral desensitization treatment for insomnia |
| 6 | Experimental | Phase 1 participants with knee OA who meet research diagnostic criteria for insomnia will enroll in Phase 2 of the study and are assigned to receive cognitive behavior therapy for insomnia Receives: Behavioral: Cognitive behavioral therapy (CBT) for insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in sleep disturbances
Measured: Measured at Weeks 4 and 8 and Months 5 and 8
Secondary outcomes (1)
Reduction in OA-related pain
Measured: Measured at Weeks 4 and 8 and Months 5 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Michael T. Smith, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592449
- Sponsor's protocol ID
- NA_00011802
- Other IDs
- R01AR054871
- Acronym
- SOAP
- Status last verified
- May 2019
- First submitted
- 28 Dec 2007
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mun CJ, Speed TJ, Finan PH, Wideman TH, Quartana PJ, Smith MT. A Preliminary Examination of the Effects and Mechanisms of Cognitive Behavioral Therapy for Insomnia on Systemic Inflammation Among Patients with Knee Osteoarthritis. Int J Behav Med. 2024 Apr;31(2):305-314. doi: 10.1007/s12529-023-10184-z. Epub 2023 May 25.
PubMed 37231221Campbell CM, Buenaver LF, Finan P, Bounds SC, Redding M, McCauley L, Robinson M, Edwards RR, Smith MT. Sleep, Pain Catastrophizing, and Central Sensitization in Knee Osteoarthritis Patients With and Without Insomnia. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1387-96. doi: 10.1002/acr.22609.
PubMed 26041510Smith MT, Finan PH, Buenaver LF, Robinson M, Haque U, Quain A, McInrue E, Han D, Leoutsakis J, Haythornthwaite JA. Cognitive-behavioral therapy for insomnia in knee osteoarthritis: a randomized, double-blind, active placebo-controlled clinical trial. Arthritis Rheumatol. 2015 May;67(5):1221-33. doi: 10.1002/art.39048.
PubMed 25623343
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbance, Central Pain Modulation, and Clinical Pain in Osteoarthritis (The SOAP Study)
- ClinicalTrials.gov ID
- NCT00592449
- Acronym / sponsor ID
- SOAP / NA_00011802
- Keywords
- Insomnia, Knee pain, Osteoarthritis, Arthritis, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Apr 2008
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 14 Jan 2008 (estimated)
- 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.
Osteoarthritis (OA) is one of the most common diseases and one of the leading causes of disability in the world. People with OA frequently experience sleep disturbances, primarily due to pain. Although insomnia is a known consequence of OA, recent studies have shown that it may also worsen clinical pain by interfering with the body's responses to painful stimuli. This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA. The study will test whether improvement in clinical pain are mediated by changes in certain types of pain processing.
Detailed description
Sleep disturbance and pain are two of the most common and disabling symptoms of OA. Sleep disturbances have been shown to worsen clinical pain by impairing some of the body's central pain processing mechanisms. Sufficient research is lacking, however, on what treatments may be effective for sleep disturbance in people with OA or whether normalization of sleep patterns in people with OA will reduce their pain. This study will evaluate the effectiveness of behavioral treatments for insomnia in reducing sleep disturbances, thereby reducing clinical pain in people with knee OA.
Participants in Phase 1 of this study will be separated into the following four groups: people with OA and insomnia; people with OA, but without insomnia; people without OA, but with insomnia; and people without OA or insomnia. All participants will attend two study visits. During Visit 1, participants will complete questionnaires and an interview and will provide a urine sample and a set of recent x-rays. A diary, which will be used to record activity levels for 2 weeks, will also be given to all participants.
Optional Ancillary Sleep and Immunoreactivity Study Procedures
Subjects who pass the visit one screen will be provided the option of participating in ancillary study procedures designed to assess inflammatory biomarkers present in plasma, physical functioning capabilities, and pain and mood status during the pain testing procedures. Subjects will be asked to give blood samples during the pain testing procedures, followed by standardized tests of physical function. Subjects will be also asked to complete additional questionnaire and diary items that ask them to rate their emotions during the pain testing procedures and during the days that they keep their electronic diary for the parent project. At Visit 2, participants will undergo pain testing, an in-home sleep study and optional procedures outlined above. At Visit 3, participants with knee osteoarthritis will have an exam by a rheumatologist.
Participants in Phase 1 who have both knee OA and insomnia will be asked to continue into Phase 2, which will last 8 months. These participants will be randomly assigned to receive two different forms of behavioral treatment, cognitive behavior therapy (CBT) or a behavioral desensitization treatment. Participants assigned to both treatments will meet with a psychologist once a week for 8 weeks. Participants will learn new sleeping habits and mental exercises designed to reduce arousal and alertness while trying to sleep. All participants will attend four assessment visits over the course of Phase 2. The first visit will occur at Week 4 and will include completing questionnaires and undergoing pain testing. The second visit will occur at Week 8 and will include the same questionnaires, further pain testing with optional blood draws and physical tests and an in-home sleep study. Two weeks before assessment Visit 3, participants will receive a diary in the mail, which they will use to keep track of their pain, sleep, medications, and symptoms until Visit 3. Assessment Visit 3 will take place at Month 5 and will include the same procedures followed during Visit 2. Participants will complete a second diary 2 weeks before Visit 4. At Visit 4, which will occur at Month 8, the same procedures completed at Visits 2 and 3 will be repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Participants with knee OA who meet research diagnostic criteria for insomnia will partake in Phase 1 |
| 2 | No intervention | –Participants with knee OA who meet research diagnostic criteria for normal sleep will partake in Phase 1 |
| 3 | No intervention | –Participants without knee OA or a pain syndrome who meet research diagnostic criteria for primary insomnia will partake in Phase 1 |
| 4 | No intervention | –Participants without knee OA or a pain syndrome who meet research diagnostic criteria for normal sleep will enroll in Phase I |
| 5 | Experimental | Behavioral: Behavioral desensitization treatment for insomniaPhase 1 participants with knee OA who meet research diagnostic criteria for insomnia will enroll in Phase 2 of the study and are assigned to receive behavioral desensitization treatment for insomnia |
| 6 | Experimental | Behavioral: Cognitive behavioral therapy (CBT) for insomniaPhase 1 participants with knee OA who meet research diagnostic criteria for insomnia will enroll in Phase 2 of the study and are assigned to receive cognitive behavior therapy for insomnia |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age ≥ 50 ; or 35 ≥ if KOA/Insomnia group
- Meets American College of Rheumatology (ACR) criteria for knee OA
- Shows radiographic evidence of Kellgren-Lawrence Grade OA greater than or equal to 1
- Experiences knee pain more than 5 days per week for more than 6 months
- Reports at least typical arthritic pain (a score of at least 2 out of 10, with 0 being no pain and 10 being the most extreme pain imaginable)
Key exclusion criteria (15 listed)
- Sleep disorders other than insomnia (e.g., obstructive sleep apnea, periodic limb movement disorder, etc.)
- Apnea/Hypopnea Index (AHI) of greater than 15
- Significant rheumatologic or painful disorders other than knee OA (including fibromyalgia, rheumatoid arthritis, neuralgia, etc.)
- Any major medical diseases known to impact sleep or cause pain (including chronic obstructive pulmonary disease, diabetes, congestive heart failure, seizure disorder, Raynaud's phenomenon, etc.)
- Dementia or cognitive impairment, defined as Mini Mental State Exam score of less than 24
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 (CBT) for insomniaAlso: CBT-IDuring CBT, participants will learn how to change their sleeping habits and reduce arousal and alertness while trying to sleep. Participants will attend 8 weekly CBT sessions with a psychologist. | Behavioural | 6 |
| Behavioral desensitization treatment for insomniaThe behavioral desensitization treatment is designed to decondition states of arousal that interfere with sleep. Participants will attend 8 weekly behavioral desensitization treatment sessions with a psychologist. | Behavioural | 5 |
Primary outcome
Reduction in sleep disturbances
Time frame: Measured at Weeks 4 and 8 and Months 5 and 8
1 secondary outcome
Reduction in OA-related pain
Time frame: Measured at Weeks 4 and 8 and Months 5 and 8
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 23 May 2019.
- Derived from this study: PubMed 37231221Mun CJ, Speed TJ, Finan PH, Wideman TH, Quartana PJ, Smith MT. A Preliminary Examination of the Effects and Mechanisms of Cognitive Behavioral Therapy for Insomnia on Systemic Inflammation Among Patients with Knee Osteoarthritis. Int J Behav Med. 2024 Apr;31(2):305-314. doi: 10.1007/s12529-023-10184-z. Epub 2023 May 25.
- Derived from this study: PubMed 26041510Campbell CM, Buenaver LF, Finan P, Bounds SC, Redding M, McCauley L, Robinson M, Edwards RR, Smith MT. Sleep, Pain Catastrophizing, and Central Sensitization in Knee Osteoarthritis Patients With and Without Insomnia. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1387-96. doi: 10.1002/acr.22609.
- Derived from this study: PubMed 25623343Smith MT, Finan PH, Buenaver LF, Robinson M, Haque U, Quain A, McInrue E, Han D, Leoutsakis J, Haythornthwaite JA. Cognitive-behavioral therapy for insomnia in knee osteoarthritis: a randomized, double-blind, active placebo-controlled clinical trial. Arthritis Rheumatol. 2015 May;67(5):1221-33. doi: 10.1002/art.39048.
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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.
Michael T. Smith, PhD principal investigator
Johns Hopkins University
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 (CBT) for insomnia and Behavioral desensitization treatment for insomnia in people with Sleep Initiation and Maintenance Disorders and Osteoarthritis, run by Johns Hopkins University 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 26 inclusion and 15 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 23 May 2019. 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?
Reduction in sleep disturbances (time frame: Measured at Weeks 4 and 8 and Months 5 and 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00592449, which also lists 3 linked publications.
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 23 May 2019.