Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2016-06-30
2020-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Chronic fatigue syndrome
Participants with chronic fatigue syndrome
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
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Stony Brook University
OTHER
Responsible Party
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Principal Investigators
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Fred Friedberg, PhD
Role: PRINCIPAL_INVESTIGATOR
Stony Brook University
Locations
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Stony Brook University
Stony Brook, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Patricia Bruckenthal, PhD, RN
Role: primary
Jenna Adamowicz, MA
Role: backup
References
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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.
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. Res Sq [Preprint]. 2023 May 5:rs.3.rs-2865400. doi: 10.21203/rs.3.rs-2865400/v1.
Friedberg 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.
Other Identifiers
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