Behavioral Insomnia Therapy With Chronic Fatigue Syndrome

NCT00540254 | Completed Phase 1 DMC

• 3 other identifiers: Pro00002157R21NR010539NIH: 1 R21 NR010539-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how best to manage the sleep problems of people with Chronic Fatigue Syndrome. This study is being conducted to determine how improvements in sleep affect other Chronic Fatigue symptoms including pain, fatigue, and mood as well as a person's sense of general well-being.

Conditions

Chronic Fatigue Syndrome; Behavioral Therapy Targeted to Sleep Problems

Keywords

Chronic Fatigue; Insomnia; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (5)

• total wake time

  Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up

• total sleep time

  Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up

• sleep efficiency

  Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up

• beliefs about sleep

  Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up

• sleep habits

  Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up

Secondary Outcomes (2)

• actigraphy (measurement of activity)

  Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up

• scores on measures of fatigue, mood, anxiety, quality of life, chronic fatigue syndrome symptoms, fibromyalgia symptoms, medication usage

  Measures taken at baseline, mid-treatment, immediate post-treatment, one-month follow-up

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Cognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems

Behavioral: Cognitive Behavioral Therapy

Arm 2

ACTIVE COMPARATOR

Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs

Other: Usual Care for Chronic Fatigue Syndrome (Active Control Group)

Interventions

Cognitive Behavioral Therapy BEHAVIORAL

Cognitive Behavioral Therapy (CBT) + Insomnia plus Usual Care for Chronic Fatigue Syndrome -continues standard care for Chronic Fatigue Syndrome plus 4 sessions of CBT targeted for insomnia/sleep problems

Arm 1

Usual Care for Chronic Fatigue Syndrome (Active Control Group) OTHER

Usual Care for Chronic Fatigue Syndrome (Active Control Group) - continues standard care for Chronic Fatigue Syndrome and comes to the sleep lab for bi-weekly sessions to discuss sleep problems and to review weekly sleep logs

Arm 2

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Fatigue Syndrome and Insomnia
• meet diagnostic criteria for insomnia
• be diagnosed with CFS by the Study Physician using CDC criteria
• must be in current treatment for CFS (we can provide referrals if needed).
• under medical care for a minimum of 6 weeks with a stable medication regimen for \> 1 month.
• Study patients can have comorbid depression (as long as it is not bipolar, melancholic or psychotic) or fibromyalgia. They can be taking sleep medications.

You may not qualify if:

• Those with untreated medical disorders that could account for the fatigue, or affect sleep. Medical conditions that would exclude a participant include:
• organ failure resulting from conditions such as emphysema, cirrhosis, cardiac failure, chronic renal failure
• chronic infections, including AIDS, and hepatitis B or C
• rheumatic and chronic inflammatory diseases that could account for the fatigue: including systemic lupus erythematosis, Sjogren's syndrome, rheumatoid arthritis, inflammatory bowel disease, chronic pancreatitis
• major neurologic diseases (e.g., multiple sclerosis, neuromuscular diseases, epilepsy or other diseases requiring ongoing medication that could cause fatigue, stroke, head injury with residual neurologic deficits)
• diseases requiring systemic treatment (e.g., organ or bone marrow transplantation, systemic chemotherapy, radiation of brain, thorax, abdomen, or pelvis)
• untreated major endocrine diseases (e.g., hypopituitarism, adrenal insufficiency)
• being on medications with known fatigue side effects or medications that have not been stable for at least one month
• inadequately-treated hypothyroidism
• untreated or unstable diabetes mellitus
• active infection
• pregnancy, 1-3 months post-partum or breast feeding
• within 6 months post-operation for a major surgical procedure
• within 3 months post-operation of minor surgery
• major infections, such as sepsis or pneumonia until 3 months post-resolution

Sponsors & Collaborators

• Duke University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Duke University Medical Center - Insomnia and Sleep Disorders Lab

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• Waters WF, Hurry MJ, Binks PG, Carney CE, Lajos LE, Fuller KH, Betz B, Johnson J, Anderson T, Tucci JM. Behavioral and hypnotic treatments for insomnia subtypes. Behav Sleep Med. 2003;1(2):81-101. doi: 10.1207/S15402010BSM0102_2.

  PMID: 15600131 BACKGROUND

• Carney CE, Edinger JD. Identifying critical beliefs about sleep in primary insomnia. Sleep. 2006 Apr;29(4):444-53.

  PMID: 16676777 BACKGROUND

• Edinger JD, Wohlgemuth WK, Radtke RA, Marsh GR, Quillian RE. Cognitive behavioral therapy for treatment of chronic primary insomnia: a randomized controlled trial. JAMA. 2001 Apr 11;285(14):1856-64. doi: 10.1001/jama.285.14.1856.

  PMID: 11308399 BACKGROUND

• Edinger JD, Wohlgemuth WK, Krystal AD, Rice JR. Behavioral insomnia therapy for fibromyalgia patients: a randomized clinical trial. Arch Intern Med. 2005 Nov 28;165(21):2527-35. doi: 10.1001/archinte.165.21.2527.

  PMID: 16314551 BACKGROUND

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Andrew Krystal, M.D.

  Duke University

  STUDY DIRECTOR

• Mark Mayo

  Duke University

  PRINCIPAL INVESTIGATOR

• Pam Smith

  Duke Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2007
• First Posted: October 5, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: March 1, 2013

Record last verified: 2010-03

Locations

US (1)