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CompletedNCT00997451Updated Oct 1, 2012

Fatigue Self-Management in Primary Care

An interventional study of Cognitive-behavioral self-management and Symptom monitoring in Medically Unexplained Chronic Fatigue and Chronic Fatigue Syndrome, sponsored by Stony Brook University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-10-01.

Sponsored by Stony Brook University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
107
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
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Study 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 control conditions: standard medical care alone or standard medical care plus an attention control symptom monitoring condition.

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Conditions studied

  • Medically Unexplained Chronic Fatigue
  • Chronic Fatigue Syndrome

Keywords

  • Medically unexplained chronic fatigue
  • Chronic fatigue syndrome
  • Cognitive-behavior therapy
  • Self-management
  • Primary care
  • Nurses
  • Economic analysis
  • Cost effectiveness
  • One year follow-up
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In context

Fatigue Syndrome, Chronic

255 studies on the registry are indexed under Fatigue Syndrome, Chronic; 59 are open to participants now.

This study's enrollment of 107 is above the median of 60 across 171 interventional studies indexed under Fatigue Syndrome, Chronic.

Browse Fatigue Syndrome, Chronic studies →

Lead sponsor

Stony Brook University is the lead sponsor of 197 studies on the registry; 37 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 11 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diagnosis of unexplained chronic fatigue
  • diagnosis of chronic fatigue syndrome

Exclusion criteria

Exclusion Criteria:

  • medically explained fatigue
  • any psychosis or dementia
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
107 participants (actual)

Study arms

  • Experimental
    Behavioral Self-Management

    Cognitive-behavioral self-management

    Behavioral: Cognitive-behavioral self-management

  • Active comparator
    Symptom Monitoring

    Behavioral: Symptom monitoring

  • No intervention
    Standard Medical Care

Interventions

  • BehavioralCognitive-behavioral self-management

    Graded activity, pacing, stress reduction, low effort pleasant activities, cognitive coping skills.

  • BehavioralSymptom monitoring

    Daily symptom via web diary

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What researchers measure

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: 3 months, 6 months, 15 months

Secondary outcomes

  1. Beck Anxiety Inventory

    Time frame: 3 months, 6 months, 15 months

  2. Beck Depression Inventory

    Time frame: 3 months, 6 months, 15 months

  3. SF-36 physical function subscale

    Time frame: 3 months, 6 months, 15 months

  4. Global Impression of Change Rating

    Time frame: 3 months, 6 months, 15 months

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Study locations

1 site
  • Stony Brook University
    Stony Brook, New York 11794, United States
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References and documents

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 25421363 ↗
  • Friedberg 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00997451
Responsible party
Sponsor
First posted
Oct 19, 2009
Start date
Feb 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Oct 1, 2012

Study contacts

Fred Friedberg, PhD
principal investigator · Stony Brook University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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