Recruiting

Observational Study

Sponsor:

Stony Brook University

Code:

NCT02948556

Conditions

Chronic Fatigue Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

Brief 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). 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.

Conditions

Chronic Fatigue Syndrome

Study ID

NCT02948556

Start date

Jun, 2016

Status verified date

Nov, 2016

Completion date

May, 2020

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic fatigue syndrome

Participants with chronic fatigue syndrome

Primary outcome measure

  • Global Impression of Change Rating [ Time Frame: six months ]

Central Contacts and Locations

Central contacts

Locations

Stony Brook University

Recruiting

Stony Brook, New York, United States, 11794-8101

Contacts

Principal Investigator:

Fred Friedberg, PhD

More Information

Sponsor

Stony Brook University

Last update posted

Nov 3, 2016

Last verified

Nov, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Stony Brook University on 2016-11-03. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.