ME/CFS: Activity Patterns and Autonomic Dysfunction

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Fatigue Syndrome

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Particia Bruckenthal, PhD, RN; Phone Number: 631-444-1172; Email: particia.bruckenthal@stonybrook.edu
• Study Contact Backup: Name: Jenna Adamowicz, MA; Phone Number: 631-371-4417; Email: jenna.adamowicz@stonybrook.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794-8101
      • Recruiting
      • Stony Brook University
      • Principal Investigator: Fred Friedberg, PhD
      • Contact: Jenna Adamowicz, MA; Phone Number: 631-371-4417; Email: jenna.adamowicz@stonybrook.edu
      • Contact: Patricia Bruckenthal, PhD, RN; Phone Number: 631-444-1172; Email: patricia.bruckenthal@stonybrook.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosed chronic fatigue syndrome

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chronic fatigue syndrome; Participants with chronic fatigue syndrome

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Impression of Change Rating	Validated Self-report rating via interview	six months

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Fred Friedberg, PhD, Stony Brook University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: October 26, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (Estimate): October 28, 2016

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Fatigue Syndrome, Chronic; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: 1R01NR015850-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes