Patient-Partner Stress Management Effects on Chronic Fatigue Syndrome Symptoms and Neuroimmune Process

University of Miami

Status: Completed

Conditions: Chronic Fatigue Syndrome

Treatments: Behavioral: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI); Behavioral: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01650636

R01NS072599 (U.S. NIH Grant/Contract)

20100771

Details and patient eligibility

About

The purpose of this study is to test the effects of a videotelephone-delivered patient-partner dual-focused cognitive behavioral stress management intervention on chronic fatigue syndrome (CFS) symptoms and related psychosocial and neuroimmune processes in patients diagnosed with chronic fatigue syndrome. Study tests the hypothesis that videophone-delivered patient-partner cognitive behavioral stress management (T-PP-CBSM) intervention improves patient CFS symptoms relative to a videophone-delivered patient-partner Health Information (PP-T- HI) condition.

Full description

The study tests the effects of a 10-week patient-partner focused videophone-delivered cognitive behavioral stress management intervention (T-PP-CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills training, interpersonal skills training) versus a time-attention-matched 10-week patient-partner based videophone-delivered health information (T-PP-HI) (health behavior education on nutrition, sleep and other factors) in men and women with chronic fatigue syndrome (CFS) and their partners. The study evaluates the effects of T-PP-CBSM vs T-PP-HI on patient CFS symptoms, neuroimmune processes--diurnal cortisol regulation and immune regulation (pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1β + IL-6 + TNF-α]:[IL-13 + IL-10])-and psychosocial functioning at 5 months and 9 months after intervention.

Enrollment: 300 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• men and women diagnosed with chronic fatigue syndrome

Exclusion criteria

• no partner
• prior psychiatric treatment for serious psychiatric disorder (e.g., psychosis, suicidality)
• co-morbidity or medical treatment affecting the immune system
• lack of fluency in English

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 2 patient groups

Cognitive Behavioral Stress Management

Experimental group

Treatment:

Behavioral: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)

Health Information

Active Comparator group

Treatment:

Behavioral: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)