Chronic Fatigue SyndromeNCT02948556
ME/CFS: Activity Patterns and Autonomic Dysfunction
An observational study of Chronic Fatigue Syndrome, run by Stony Brook University at 1 site in United States.
Trial summary
The purpose of this study is to identify daily activity patterns, negative life events and autonomic abnormalities that may be related to non-improvement in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to May 2020
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosed chronic fatigue syndrome
Who may be able to join
- Fukuda-based ME/CFS symptoms including:
- six months of unexplained, debilitating fatigue
- 4/8 secondary symptoms impaired memory or concentration unrefreshing sleep sore throats headache muscle pain joint pain tender lymph nodes post-exertional malaise
Who cannot join
- Medical: fatigue clearly attributable to self-report medical conditions.
- Psychiatric any psychosis alcohol/ substance abuse within two years prior or after illness onset. depression with melancholic/psychotic features within 5 years of onset .
- Two other exclusionary criteria:
- patients not dose-stabilized for at least 3 months on antidepressants ;
- patients at risk of suicide or need of urgent psychiatric treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794-8101
Patricia Bruckenthal, PhD, RN, 631-444-1172, patricia.bruckenthal@stonybrook.edu
Jenna Adamowicz, MA, 631-371-4417, jenna.adamowicz@stonybrook.edu
About this study
The purpose of this study is to identify daily activity patterns, negative life events and autonomic abnormalities that may be related to non-improvement in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and behavioral intervention trials, roughly 50% of patients report worsening or unchanged illness. The proposed four year study would be the first to look at the relation between illness non-improvement, patient activities at home and autonomic function. Our long-range goal is to identify physiological signals and activity patterns that predict non-improvement and relapse and develop a self-management program that prescribes improvement-linked behaviors and discourages non-improvement activities.
Read the detailed description
Given the enduring debilitation and poor quality of life in ME/CFS, this study proposes to identify important activity patterns (e.g., push-crash), negative life events and autonomic dysfunction that may be associated with non-improvement. This will be accomplished with weekly online diaries, objective measures (actigraphy, heart rate monitors) and semi-structured phone interviews. Non-improvement is a rarely studied, but commonly reported outcome in this illness. For both naturalistic studies and behavioral intervention trials, roughly 50% of ME/CFS patients report worsening or unchanged illness. Also, the patient's self-management efforts may (paradoxically) produce symptom worsening and contribute to illness non-improvement. Non-improvement may also have biological relevance because activity limitations and sleep disruption in ME/CFS have both been associated with autonomic dysregulation (reduced heart rate variability). This (R01) prospective observational six month study of both daily and weekly in vivo assessments would be the first to look at non-improvement in relation to ongoing patient activities and autonomic function.
Specific Aim 1: To assess the relation between non-improvement and prospectively assessed activity patterns and life events. Hypothesis 1: Non-improvement will be significantly associated with these dimensional variables: (a) illness-exacerbating activity patterns (e.g., "push-crash") reported on home web diaries; (b) daily hassles assessed in web diaries; and (c) negative life events reported in phone interviews.
Specific Aim 2: To assess the relation between improvement and prospectively assessed activity patterns and life events. Hypothesis 2: Improvement will be significantly associated with: (a) illness-moderating activity patterns (e.g., healthy pacing) reported on home web diaries; (b) daily uplifts assessed in web diaries; and (c) positive life events assessed in phone interviews.
Specific Aim 3: To assess the relation between activity patterns and symptoms. Hypothesis 3: (a) the "push-crash" pattern will predict greater actigraphy variability and symptom variability; (b) the "limiting activity" pattern will be associated with very low actigraphy counts and high symptom severity; and (c) a healthier "pacing" pattern will be associated with moderate variability of actigraphy and symptoms.
Our secondary aim hypothesizes that autonomic dysregulation (reduced heart rate variability [HRV]) will be characteristic of both non-improvers and patients with a limiting activity pattern as compared to improvers and those with a healthy pacing pattern. The long-range goal is to develop a new self-management protocol that more clearly identifies non-improvement activities and how they can be changed. An important aspect of this new self-management protocol would be to identify early signals of impending relapse, particularly HRV status, via home-use portable devices that could be utilized by patients and their doctors as a warning to modify non-improvement activities, e.g., excessive activity or exercise, to prevent behavioral collapse into inactivity.
- Conditions
- Chronic Fatigue Syndrome
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic fatigue syndrome | Participants with chronic fatigue syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Impression of Change Rating
Validated Self-report rating via interview
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2019 (estimated)
- Study completionMay 2020 (estimated)
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 Chronic Fatigue SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
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
- NCT02948556
- Sponsor's protocol ID
- 1R01NR015850-01A1
- Status last verified
- Nov 2016
- First submitted
- 26 Oct 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Friedberg F, Adamowicz JL, Bruckenthal P, Milazzo M, Ramjan S, Zhang X, Yang J. Uplifts and hassles are related to worsening in chronic fatigue syndrome: a prospective study. J Transl Med. 2023 Aug 20;21(1):557. doi: 10.1186/s12967-023-04412-z.
PubMed 37598161Friedberg F, Adamowicz JL, Bruckenthal P, Milazzo M, Ramjan S, Zhang X, Yang J. Uplifts and hassles are related to worsening in chronic fatigue syndrome A prospective study. Res Sq [Preprint]. 2023 May 5:rs.3.rs-2865400. doi: 10.21203/rs.3.rs-2865400/v1.
PubMed 37205559Friedberg F, Adamowicz JL, Bruckenthal P, Milazzo M, Ramjan S, Quintana D. Nonimprovement in Chronic Fatigue Syndrome: Relation to Activity Patterns, Uplifts and Hassles, and Autonomic Dysfunction. Psychosom Med. 2022 Jul-Aug 01;84(6):669-678. doi: 10.1097/PSY.0000000000001082. Epub 2022 Apr 14.
PubMed 35420586
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ME/CFS: Activity Patterns and Autonomic Dysfunction
- ClinicalTrials.gov ID
- NCT02948556
- Acronym / sponsor ID
- 1R01NR015850-01A1
- Conditions
- Chronic Fatigue Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 28 Oct 2016 (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 identify daily activity patterns, negative life events and autonomic abnormalities that may be related to non-improvement in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). For both naturalistic studies and behavioral intervention trials, roughly 50% of patients report worsening or unchanged illness. The proposed four year study would be the first to look at the relation between illness non-improvement, patient activities at home and autonomic function. Our long-range goal is to identify physiological signals and activity patterns that predict non-improvement and relapse and develop a self-management program that prescribes improvement-linked behaviors and discourages non-improvement activities.
Detailed description
Given the enduring debilitation and poor quality of life in ME/CFS, this study proposes to identify important activity patterns (e.g., push-crash), negative life events and autonomic dysfunction that may be associated with non-improvement. This will be accomplished with weekly online diaries, objective measures (actigraphy, heart rate monitors) and semi-structured phone interviews. Non-improvement is a rarely studied, but commonly reported outcome in this illness. For both naturalistic studies and behavioral intervention trials, roughly 50% of ME/CFS patients report worsening or unchanged illness. Also, the patient's self-management efforts may (paradoxically) produce symptom worsening and contribute to illness non-improvement. Non-improvement may also have biological relevance because activity limitations and sleep disruption in ME/CFS have both been associated with autonomic dysregulation (reduced heart rate variability). This (R01) prospective observational six month study of both daily and weekly in vivo assessments would be the first to look at non-improvement in relation to ongoing patient activities and autonomic function.
Specific Aim 1: To assess the relation between non-improvement and prospectively assessed activity patterns and life events. Hypothesis 1: Non-improvement will be significantly associated with these dimensional variables: (a) illness-exacerbating activity patterns (e.g., "push-crash") reported on home web diaries; (b) daily hassles assessed in web diaries; and (c) negative life events reported in phone interviews.
Specific Aim 2: To assess the relation between improvement and prospectively assessed activity patterns and life events. Hypothesis 2: Improvement will be significantly associated with: (a) illness-moderating activity patterns (e.g., healthy pacing) reported on home web diaries; (b) daily uplifts assessed in web diaries; and (c) positive life events assessed in phone interviews.
Specific Aim 3: To assess the relation between activity patterns and symptoms. Hypothesis 3: (a) the "push-crash" pattern will predict greater actigraphy variability and symptom variability; (b) the "limiting activity" pattern will be associated with very low actigraphy counts and high symptom severity; and (c) a healthier "pacing" pattern will be associated with moderate variability of actigraphy and symptoms.
Our secondary aim hypothesizes that autonomic dysregulation (reduced heart rate variability [HRV]) will be characteristic of both non-improvers and patients with a limiting activity pattern as compared to improvers and those with a healthy pacing pattern. The long-range goal is to develop a new self-management protocol that more clearly identifies non-improvement activities and how they can be changed. An important aspect of this new self-management protocol would be to identify early signals of impending relapse, particularly HRV status, via home-use portable devices that could be utilized by patients and their doctors as a warning to modify non-improvement activities, e.g., excessive activity or exercise, to prevent behavioral collapse into inactivity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic fatigue syndrome | – | –Participants with chronic fatigue syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosed chronic fatigue syndrome
Key inclusion criteria (3 listed)
- six months of unexplained, debilitating fatigue
- 4/8 secondary symptoms impaired memory or concentration unrefreshing sleep sore throats headache muscle pain joint pain tender lymph nodes post-exertional malaise
Key exclusion criteria (5 listed)
- Medical: fatigue clearly attributable to self-report medical conditions.
- Psychiatric any psychosis alcohol/ substance abuse within two years prior or after illness onset. depression with melancholic/psychotic features within 5 years of onset .
- patients not dose-stabilized for at least 3 months on antidepressants ;
- patients at risk of suicide or need of urgent psychiatric treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Global Impression of Change Rating
Time frame: six months
Validated Self-report rating via interview
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Derived from this study: PubMed 37598161Friedberg F, Adamowicz JL, Bruckenthal P, Milazzo M, Ramjan S, Zhang X, Yang J. Uplifts and hassles are related to worsening in chronic fatigue syndrome: a prospective study. J Transl Med. 2023 Aug 20;21(1):557. doi: 10.1186/s12967-023-04412-z.
- Derived from this study: PubMed 37205559Friedberg F, Adamowicz JL, Bruckenthal P, Milazzo M, Ramjan S, Zhang X, Yang J. Uplifts and hassles are related to worsening in chronic fatigue syndrome A prospective study. Res Sq [Preprint]. 2023 May 5:rs.3.rs-2865400. doi: 10.21203/rs.3.rs-2865400/v1.
- Derived from this study: PubMed 35420586Friedberg F, Adamowicz JL, Bruckenthal P, Milazzo M, Ramjan S, Quintana D. Nonimprovement in Chronic Fatigue Syndrome: Relation to Activity Patterns, Uplifts and Hassles, and Autonomic Dysfunction. Psychosom Med. 2022 Jul-Aug 01;84(6):669-678. doi: 10.1097/PSY.0000000000001082. Epub 2022 Apr 14.
- Individual participant dataSharing planned: Yes
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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?
An observational study of 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 3 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: status not confirmed, as of the sponsor's last update on 3 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Particia Bruckenthal, PhD, RN (631-444-1172, particia.bruckenthal@stonybrook.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Impression of Change Rating (time frame: six 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 NCT02948556, 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 3 Nov 2016.