MedDataX Logo

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

NCT ID: NCT01650636

Last Updated: 2018-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Fatigue Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Videophone-delivered stress management intervention Chronic fatigue syndrome Symptoms Neuroimmune processes Psychosocial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cognitive Behavioral Stress Management

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

Ten (10) 90-min sessions of T-PP-CBSM

Health Information

Group Type ACTIVE_COMPARATOR

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

Intervention Type BEHAVIORAL

Ten (10) 90-min sessions of Health Information delivered via videophones

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Ten (10) 90-min sessions of Health Information delivered via videophones

Intervention Type BEHAVIORAL

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

Ten (10) 90-min sessions of T-PP-CBSM

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael H. Antoni

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychology University of Miami

Coral Gables, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Milrad SF, Hall DL, Jutagir DR, Lattie EG, Czaja SJ, Perdomo DM, Ironson G, Doss BD, Mendez A, Fletcher MA, Klimas N, Antoni MH. Relationship satisfaction, communication self-efficacy, and chronic fatigue syndrome-related fatigue. Soc Sci Med. 2019 Sep;237:112392. doi: 10.1016/j.socscimed.2019.112392. Epub 2019 Jul 16.

Reference Type DERIVED
PMID: 31377502 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01NS072599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20100771

Identifier Type: -

Identifier Source: org_study_id