Chronic Fatigue SyndromePhase 1/2NCT00540254
Behavioral Insomnia Therapy With Chronic Fatigue Syndrome
A Phase 1/2 study testing Cognitive Behavioral Therapy in people with Chronic Fatigue Syndrome and Behavioral Therapy Targeted to Sleep Problems, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine how best to manage the sleep problems of people with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a person's sense of general well-being. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Chronic Fatigue Syndrome, Behavioral Therapy Targeted to Sleep Problems
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2010
- Phase
- Phase 1/2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Fatigue Syndrome and Insomnia
- meet diagnostic criteria for insomnia
- be diagnosed with CFS by the Study Physician using CDC criteria
- must be in current treatment for CFS (we can provide referrals if needed).
- under medical care for a minimum of 6 weeks with a stable medication regimen for > 1 month.
- Study patients can have comorbid depression (as long as it is not bipolar, melancholic or psychotic) or fibromyalgia. They can be taking sleep medications.
Who cannot join
- Those with untreated medical disorders that could account for the fatigue, or affect sleep. Medical conditions that would exclude a participant include:
- organ failure resulting from conditions such as emphysema, cirrhosis, cardiac failure, chronic renal failure
- chronic infections, including AIDS, and hepatitis B or C
- rheumatic and chronic inflammatory diseases that could account for the fatigue: including systemic lupus erythematosis, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis
- major neurologic diseases (e.g., multiple sclerosis, neuromuscular diseases, epilepsy or other diseases requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)
- diseases requiring systemic treatment (e.g., organ or bone marrow transplantation, systemic chemotherapy, radiation of brain, thorax, abdomen, or pelvis)
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- untreated major endocrine diseases (e.g., hypopituitarism, adrenal insufficiency)
- being on medications with known fatigue side effects or medications that have not been stable for at least one month
- inadequately-treated hypothyroidism
- untreated or unstable diabetes mellitus
- active infection
- pregnancy, 1-3 months post-partum or breast feeding
- within 6 months post-operation for a major surgical procedure
- within 3 months post-operation of minor surgery
- major infections, such as sepsis or pneumonia until 3 months post-resolution
- major conditions whose resolution may be unclear for at least 5 years (e.g., myocardial infarction, heart failure)
- terminal conditions
- severe obesity as defined as a body mass index (weight in kilograms/height in meters)2 > 40
- elective surgery planned during the trial
- We will exclude those who meet DSM-IV criteria currently or in the past 5 years for psychotic or melancholic Major Depression, bipolar disorders, schizophrenia, or eating disorders, alcohol or substance abuse or dependence (e.g., dependence on benzodiazepines or any other substance)
- We will exclude those meeting criteria for Narcolepsy, Restless Legs Syndrome, a Circadian Rhythm Disorder, or sleep apnea and/or hypopnea.
- We will exclude those with a medication change within the last month to ensure participants are on a stable dose and regimen of medication. *Once potential patients have had a stable medication regimen for > 1 month, participants can enter the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center - Insomnia and Sleep Disorders Lab
Durham, North Carolina, 27710
About this study
The purpose of this study is to determine how best to manage the sleep problems of people with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a person's sense of general well-being.
Read the detailed description
Chronic Fatigue Syndrome (CFS) is a prevalent, debilitating, and poorly understood condition that contributes to impaired functioning and increased health care utilization. The vast majority of CFS patients complain of unrelenting sleep disturbances (e.g., sleep onset insomnia and/or sleep maintenance insomnia) that could exacerbate symptoms such as fatigue, mood disturbance, and reduced quality of life. Research with normal sleepers and insomnia sufferers has demonstrated that sleep disruption adversely affects those systems hypothesized to be important in CFS (e.g., neuroendocrine and autonomic systems). Insomnia appears to be a perpetuating factor in CFS, as insomnia appears to develop as a comorbid condition that interacts with and worsens CFS. Perhaps because the insomnia of CFS patients traditionally has been viewed as a secondary symptom rather than as a comorbid disorder, the sleep-specific treatment needs of CFS patients have been largely ignored. In fact, there have been few studies conducted to test sleep-focused therapies with CFS patients. Both our clinical observations and our preliminary studies suggest that those with CFS display sleep targets (i.e., increased time-in-bed, decreased daytime activity) that are common to those with Primary and other comorbid insomnias. These phenomena are known to perpetuate sleep problems, and likely account for the chronic insomnia among CFS patients. Given the high prevalence and cost associated with CFS, as well as its complex clinical picture, interventions that directly address perpetuating mechanisms would likely improve the sleep and general prognosis for these patients.
The proposed randomized clinical trial will allow us to test the effects of CBT for Insomnia on sleep and waking functions among CFS patients. Positive results could lead to enhanced CFS outcomes by treating the comorbid insomnia effectively.
The consent form for this study will provide participants with information about who will provide their care during the study, the purpose of the study, the number of participants expected in the study, what is required of participants in the study, information about random assignment to study groups, how long participation in the study will last, the risks associated with the study, possible benefits of participation, alternatives for treatment other than participation in this study, information about confidentiality, costs to the participants associated with the study, compensation for participation, and who to contact if there questions about the study or injuries related to the study, the right to stop participating and withdraw from the study.
- Being tested
- Cognitive Behavioral Therapy, Usual Care for Chronic Fatigue Syndrome (Active Control Group)
- Keywords
- Chronic Fatigue, Insomnia, Cognitive Behavioral Therapy
- Medical subject headings
- Fatigue Syndrome, Chronic, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Cognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems
Usual Care for Chronic Fatigue Syndrome (Active Control Group)Other
Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Cognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems Receives: Behavioral: Cognitive Behavioral Therapy |
| Arm 2 | Active comparator | Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs Receives: Other: Usual Care for Chronic Fatigue Syndrome (Active Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
total wake time
Measured: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
total sleep time
Measured: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
sleep efficiency
Measured: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
beliefs about sleep
Measured: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
sleep habits
Measured: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
Secondary outcomes (2)
actigraphy (measurement of activity)
Measured: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
scores on measures of fatigue, mood, anxiety, quality of life, chronic fatigue syndrome symptoms, fibromyalgia symptoms, medication usage
Measured: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Duke 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Andrew Krystal, M.D., Study director, Duke UniversityMark Mayo, Principal investigator, Duke UniversityPam Smith, Principal investigator, Duke Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540254
- Sponsor's protocol ID
- Pro00002157
- Other IDs
- R21NR010539, NIH: 1 R21 NR010539-01A1
- Status last verified
- Mar 2010
- First submitted
- 3 Oct 2007
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Waters WF, Hurry MJ, Binks PG, Carney CE, Lajos LE, Fuller KH, Betz B, Johnson J, Anderson T, Tucci JM. Behavioral and hypnotic treatments for insomnia subtypes. Behav Sleep Med. 2003;1(2):81-101. doi: 10.1207/S15402010BSM0102_2.
PubMed 15600131Carney CE, Edinger JD. Identifying critical beliefs about sleep in primary insomnia. Sleep. 2006 Apr;29(4):444-53.
PubMed 16676777Edinger JD, Wohlgemuth WK, Radtke RA, Marsh GR, Quillian RE. Cognitive behavioral therapy for treatment of chronic primary insomnia: a randomized controlled trial. JAMA. 2001 Apr 11;285(14):1856-64. doi: 10.1001/jama.285.14.1856.
PubMed 11308399Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. doi: 10.1001/archinte.165.21.2527.
PubMed 16314551
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Insomnia Therapy With Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT00540254
- Acronym / sponsor ID
- Pro00002157
- Keywords
- Chronic Fatigue, Insomnia, Cognitive Behavioral Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Oct 2007 (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.
The purpose of this study is to determine how best to manage the sleep problems of people with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a person's sense of general well-being.
Detailed description
Chronic Fatigue Syndrome (CFS) is a prevalent, debilitating, and poorly understood condition that contributes to impaired functioning and increased health care utilization. The vast majority of CFS patients complain of unrelenting sleep disturbances (e.g., sleep onset insomnia and/or sleep maintenance insomnia) that could exacerbate symptoms such as fatigue, mood disturbance, and reduced quality of life. Research with normal sleepers and insomnia sufferers has demonstrated that sleep disruption adversely affects those systems hypothesized to be important in CFS (e.g., neuroendocrine and autonomic systems). Insomnia appears to be a perpetuating factor in CFS, as insomnia appears to develop as a comorbid condition that interacts with and worsens CFS. Perhaps because the insomnia of CFS patients traditionally has been viewed as a secondary symptom rather than as a comorbid disorder, the sleep-specific treatment needs of CFS patients have been largely ignored. In fact, there have been few studies conducted to test sleep-focused therapies with CFS patients. Both our clinical observations and our preliminary studies suggest that those with CFS display sleep targets (i.e., increased time-in-bed, decreased daytime activity) that are common to those with Primary and other comorbid insomnias. These phenomena are known to perpetuate sleep problems, and likely account for the chronic insomnia among CFS patients. Given the high prevalence and cost associated with CFS, as well as its complex clinical picture, interventions that directly address perpetuating mechanisms would likely improve the sleep and general prognosis for these patients.
The proposed randomized clinical trial will allow us to test the effects of CBT for Insomnia on sleep and waking functions among CFS patients. Positive results could lead to enhanced CFS outcomes by treating the comorbid insomnia effectively.
The consent form for this study will provide participants with information about who will provide their care during the study, the purpose of the study, the number of participants expected in the study, what is required of participants in the study, information about random assignment to study groups, how long participation in the study will last, the risks associated with the study, possible benefits of participation, alternatives for treatment other than participation in this study, information about confidentiality, costs to the participants associated with the study, compensation for participation, and who to contact if there questions about the study or injuries related to the study, the right to stop participating and withdraw from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems |
| Arm 2 | Active comparator | Other: Usual Care for Chronic Fatigue Syndrome (Active Control Group)Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic Fatigue Syndrome and Insomnia
- meet diagnostic criteria for insomnia
- be diagnosed with CFS by the Study Physician using CDC criteria
- must be in current treatment for CFS (we can provide referrals if needed).
- under medical care for a minimum of 6 weeks with a stable medication regimen for > 1 month.
Key exclusion criteria (22 listed)
- Those with untreated medical disorders that could account for the fatigue, or affect sleep. Medical conditions that would exclude a participant include:
- We will exclude those who meet DSM-IV criteria currently or in the past 5 years for psychotic or melancholic Major Depression, bipolar disorders, schizophrenia, or eating disorders, alcohol or substance abuse or dependence (e.g., dependence on benzodiazepines or any other substance)
- We will exclude those meeting criteria for Narcolepsy, Restless Legs Syndrome, a Circadian Rhythm Disorder, or sleep apnea and/or hypopnea.
- We will exclude those with a medication change within the last month to ensure participants are on a stable dose and regimen of medication. *Once potential patients have had a stable medication regimen for > 1 month, participants can enter the trial.
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 TherapyCognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems | Behavioural | Arm 1 |
| Usual Care for Chronic Fatigue Syndrome (Active Control Group)Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs | Other | Arm 2 |
Primary outcome
total wake time
Time frame: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
total sleep time
Time frame: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
sleep efficiency
Time frame: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
beliefs about sleep
Time frame: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
sleep habits
Time frame: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
2 secondary outcomes
actigraphy (measurement of activity)
Time frame: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
scores on measures of fatigue, mood, anxiety, quality of life, chronic fatigue syndrome symptoms, fibromyalgia symptoms, medication usage
Time frame: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up
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 1 Mar 2013.
- Background: PubMed 15600131Waters WF, Hurry MJ, Binks PG, Carney CE, Lajos LE, Fuller KH, Betz B, Johnson J, Anderson T, Tucci JM. Behavioral and hypnotic treatments for insomnia subtypes. Behav Sleep Med. 2003;1(2):81-101. doi: 10.1207/S15402010BSM0102_2.
- Background: PubMed 16676777Carney CE, Edinger JD. Identifying critical beliefs about sleep in primary insomnia. Sleep. 2006 Apr;29(4):444-53.
- Background: PubMed 11308399Edinger JD, Wohlgemuth WK, Radtke RA, Marsh GR, Quillian RE. Cognitive behavioral therapy for treatment of chronic primary insomnia: a randomized controlled trial. JAMA. 2001 Apr 11;285(14):1856-64. doi: 10.1001/jama.285.14.1856.
- Background: PubMed 16314551Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. doi: 10.1001/archinte.165.21.2527.
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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.
Andrew Krystal, M.D. study director
Duke University
Mark Mayo principal investigator
Duke University
Pam Smith principal investigator
Duke Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive Behavioral Therapy in people with Chronic Fatigue Syndrome and Behavioral Therapy Targeted to Sleep Problems, run by Duke 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 6 inclusion and 22 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 1 Mar 2013. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
total wake time (time frame: Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up). The study lists 5 primary outcomes in all. 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 NCT00540254, which also lists 4 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 1 Mar 2013.