NCT00997451

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2009

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 1, 2012

Status Verified

September 1, 2012

Enrollment Period

2.8 years

First QC Date

March 28, 2009

Last Update Submit

September 28, 2012

Conditions

Medically Unexplained Chronic FatigueChronic Fatigue Syndrome

Keywords

Medically unexplained chronic fatigueChronic fatigue syndromeCognitive-behavior therapySelf-managementPrimary careNursesEconomic analysisCost effectivenessOne year follow-up

Outcome Measures

Primary Outcomes (1)

  • Fatigue Severity Scale

    3 months, 6 months, 15 months

Secondary Outcomes (4)

  • Beck Anxiety Inventory

    3 months, 6 months, 15 months

  • Beck Depression Inventory

    3 months, 6 months, 15 months

  • SF-36 physical function subscale

    3 months, 6 months, 15 months

  • Global Impression of Change Rating

    3 months, 6 months, 15 months

Study Arms (3)

Behavioral Self-Management

EXPERIMENTAL

Cognitive-behavioral self-management

Behavioral: Cognitive-behavioral self-management

Symptom Monitoring

ACTIVE COMPARATOR
Behavioral: Symptom monitoring

Standard Medical Care

NO INTERVENTION

Interventions

Cognitive-behavioral self-managementBEHAVIORAL

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

Behavioral Self-Management
Symptom monitoringBEHAVIORAL

Daily symptom via web diary

Symptom Monitoring

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • medically explained fatigue
  • any psychosis or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (2)

  • 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.

    PMID: 25421363DERIVED

  • 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.

    PMID: 23922399DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fred Friedberg, PhD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2009

First Posted

October 19, 2009

Study Start

February 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 1, 2012

Record last verified: 2012-09

Locations

US(1)