Medically Unexplained Chronic FatigueNCT00997451
Fatigue Self-Management in Primary Care
A study testing Cognitive-behavioral self-management and Symptom monitoring in people with Medically Unexplained Chronic Fatigue and Chronic Fatigue Syndrome, run by Stony Brook University at 1 site in United States.
Trial summary
This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Medically Unexplained Chronic Fatigue, Chronic Fatigue Syndrome
- What is being tested?
- Cognitive-behavioral self-management and Symptom monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Dec 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of unexplained chronic fatigue
- diagnosis of chronic fatigue syndrome
Who cannot join
- medically explained fatigue
- any psychosis or dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics
This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.
- Being tested
- Cognitive-behavioral self-management, Symptom monitoring
- Keywords
- Medically unexplained chronic fatigue, Chronic fatigue syndrome, Cognitive-behavior therapy, Self-management, Primary care, Nurses, Economic analysis, Cost effectiveness, One year follow-up
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral self-managementBehavioural
Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.
Symptom monitoringBehavioural
Daily symptom via web diary
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Self-Management | Experimental | Cognitive-behavioral self-management Receives: Behavioral: Cognitive-behavioral self-management |
| Symptom Monitoring | Active comparator | Not described Receives: Behavioral: Symptom monitoring |
| Standard Medical Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Measured: 3 months, 6 months, 15 months
Secondary outcomes (4)
Beck Anxiety Inventory
Measured: 3 months, 6 months, 15 months
Beck Depression Inventory
Measured: 3 months, 6 months, 15 months
SF-36 physical function subscale
Measured: 3 months, 6 months, 15 months
Global Impression of Change Rating
Measured: 3 months, 6 months, 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medically Unexplained Chronic FatigueStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fred Friedberg, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997451
- Sponsor's protocol ID
- NIH 5R01NR010229 - 03
- Status last verified
- Sep 2012
- First submitted
- 28 Mar 2009
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Meng H, Friedberg F, Castora-Binkley M. Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial. BMC Fam Pract. 2014 Nov 25;15:184. doi: 10.1186/s12875-014-0184-7.
PubMed 25421363Friedberg F, Napoli A, Coronel J, Adamowicz J, Seva V, Caikauskaite I, Ngan MC, Chang J, Meng H. Chronic fatigue self-management in primary care: a randomized trial. Psychosom Med. 2013 Sep;75(7):650-7. doi: 10.1097/PSY.0b013e31829dbed4. Epub 2013 Aug 6.
PubMed 23922399
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue Self- Management in Primary Care: Efficacy, Credibility, and Economics
- ClinicalTrials.gov ID
- NCT00997451
- Acronym / sponsor ID
- NIH 5R01NR010229 - 03
- Keywords
- Medically unexplained chronic fatigue, Chronic fatigue syndrome, Cognitive-behavior therapy, Self-management, Primary care, Nurses, Economic analysis, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Oct 2009 (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.
This study will evaluate, in a primary care setting, the effectiveness of a brief self-management behavioral treatment in patients with medically unexplained chronic fatigue. The hypothesis will be tested that fatigue self-management will yield improvements in fatigue,functioning, and distress in comparison to the two control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Behavioral Self-Management | Experimental | Behavioral: Cognitive-behavioral self-managementCognitive-behavioral self-management |
| Symptom Monitoring | Active comparator | Behavioral: Symptom monitoring |
| Standard Medical Care | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of unexplained chronic fatigue
- diagnosis of chronic fatigue syndrome
Key exclusion criteria (2 listed)
- medically explained fatigue
- any psychosis or dementia
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 self-managementGraded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills. | Behavioural | Behavioral Self-Management |
| Symptom monitoringDaily symptom via web diary | Behavioural | Symptom Monitoring |
Primary outcome
Fatigue Severity Scale
Time frame: 3 months, 6 months, 15 months
4 secondary outcomes
Beck Anxiety Inventory
Time frame: 3 months, 6 months, 15 months
Beck Depression Inventory
Time frame: 3 months, 6 months, 15 months
SF-36 physical function subscale
Time frame: 3 months, 6 months, 15 months
Global Impression of Change Rating
Time frame: 3 months, 6 months, 15 months
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 Oct 2012.
- Derived from this study: PubMed 25421363Meng H, Friedberg F, Castora-Binkley M. Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial. BMC Fam Pract. 2014 Nov 25;15:184. doi: 10.1186/s12875-014-0184-7.
- Derived from this study: PubMed 23922399Friedberg F, Napoli A, Coronel J, Adamowicz J, Seva V, Caikauskaite I, Ngan MC, Chang J, Meng H. Chronic fatigue self-management in primary care: a randomized trial. Psychosom Med. 2013 Sep;75(7):650-7. doi: 10.1097/PSY.0b013e31829dbed4. Epub 2013 Aug 6.
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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.
Fred Friedberg, PhD principal investigator
Stony Brook 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 self-management and Symptom monitoring in people with Medically Unexplained Chronic Fatigue and Chronic Fatigue Syndrome, run by Stony Brook 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 2 inclusion and 2 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 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?
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?
Fatigue Severity Scale (time frame: 3 months, 6 months, 15 months). 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 NCT00997451, which also lists 2 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 Oct 2012.