Fatigue Self-Management in Primary Care

NCT ID: NCT00997451

Last Updated: 2012-10-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Medically Unexplained Chronic Fatigue Chronic Fatigue Syndrome

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Behavioral Self-Management

Cognitive-behavioral self-management

Group Type EXPERIMENTAL

Cognitive-behavioral self-management

Intervention Type BEHAVIORAL

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

Symptom Monitoring

Group Type ACTIVE_COMPARATOR

Symptom monitoring

Intervention Type BEHAVIORAL

Daily symptom via web diary

Standard Medical Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive-behavioral self-management

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

Intervention Type BEHAVIORAL

Symptom monitoring

Daily symptom via web diary

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of unexplained chronic fatigue
* diagnosis of chronic fatigue syndrome

Exclusion Criteria

* medically explained fatigue
* any psychosis or dementia
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stony Brook University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25421363 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23922399 (View on PubMed)

Other Identifiers

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NIH 5R01NR010229 - 03

Identifier Type: -

Identifier Source: org_study_id