Chronic Fatigue SyndromeNCT01650636

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

A study testing Patient-Partner Videotelephone-delivered Health Information (PP-T-HI) and Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM) in people with Chronic Fatigue Syndrome, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 75 years
Conditions the study is for: Chronic Fatigue Syndrome
What is being tested?: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI) and Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteUnited States
Study dates: Oct 2010to May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

men and women diagnosed with chronic fatigue syndrome

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Department of Psychology University of Miami
Coral Gables, Florida, 33124

Other trials in United States

About this study

Official title: Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process

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.

Read the detailed 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.

Conditions: Chronic Fatigue Syndrome
Being tested: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI), Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
Keywords: Videophone-delivered stress management intervention, Chronic fatigue syndrome, Symptoms, Neuroimmune processes, Psychosocial
Medical subject headings: Fatigue Syndrome, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)Behavioural
Ten (10) 90-min sessions of Health Information delivered via videophones
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)Behavioural
Ten (10) 90-min sessions of T-PP-CBSM

Study groups in NCT01650636
Study group	Role	What they receive
Cognitive Behavioral Stress Management	Experimental	Not described Receives: Behavioral: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
Health Information	Active comparator	Not described Receives: Behavioral: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Frequency and Severity of CDC-based CFS Symptoms
Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency across all symptoms, and 2) Average Symptom Severity, reflecting an aggregated average of severity across all symptoms. Change scores are expressed and calculated as Follow-Up minus Baseline scores for average symptom frequency and average symptom severity.
Measured: baseline and 5 and 9 month post-intervention follow-up
Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms
Changes in the composite product of average frequency and severity scores of CDC-based CFS symptoms assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The composite outcome measure was calculated as the product of Average Symptom Frequency and Average Symptom Severity. Change scores are expressed and calculated as Follow-Up minus Baseline scores for the composite product score.
Measured: baseline and 5 and 9 months post-intervention follow-up

Secondary outcomes (5)

Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.
Changes in salivary cortisol diurnal pattern is measured to determine changes in neuroimmune function. Salivary cortisol diurnal pattern is computed as the natural log of the average within-day slope of change over the 2-day collection period. This measurement is made at baseline, 5 month follow-up and 9 month follow-up. Outcomes are expressed as change in Cortisol Diurnal Pattern (natural log of average 2-day slope values) and expressed and calculated as Follow-Up minus Baseline values (using the natural log of average 2-day slope values).
Measured: baseline and 5 and 9 month post-intervention follow-up
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
Serum samples were collected to measure the pro-inflammatory cytokines Interleukin (IL)-1a, IL-6 and Tumor Necrosis Factor (TNF)-a for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).
Measured: Baseline, 5 months, 9 months
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
Serum samples were collected to measure the anti-inflammatory cytokines Interleukin (IL)-4, IL-5 and IL-10 for neuroimmune function. Units of measure are raw concentration expressed picograms per milliliter (pg/mL). Change values are expressed and calculated as Follow-Up minus Baseline values (using raw values).
Measured: Baseline, 5 months, 9 months
Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines
Serum samples were collected to measure the pro-inflammatory:anti-inflammatory cytokine ratio ([IL-1β + IL-6 + TNF-α]:[IL-13 + IL-10]) for neuroimmune function. These values are expressed as ratios. Change values are expressed and calculated as Follow-Up minus Baseline values (using ratio values).
Measured: baseline and 5 and 9 months post-intervention follow-up
Changes in Psychosocial Functioning
Changes in psychosocial functioning measured with the Perceived Stress Scale (PSS), Center for Epidemiologic Studies-Depression (CES-D) scale, and the subscales of the Sickness Impact Profile (SIP) for Recreation and Pastimes, and Social Interaction. Greater scores on the PSS indicate greater perceived stress (range: 0-56) and greater scores on the CES-D indicate greater depressive symptoms (range: 0-60). The SIP is divided into 'Social Interaction' and 'Recreation and Pastimes' subscales (ranges: 0-11 and 0-5, respectively), with greater scores indicating greater impact of sickness in the respective domain. Change scores are expressed and calculated as Follow-Up minus Baseline scores.
Measured: baseline and 5 and 9 month post-intervention follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010May 2017

First posted26 Jul 2012 (estimated)
Study startOct 2010
Primary completionMay 2017
Study completionMay 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
More trials run by University of MiamiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01650636
Sponsor's protocol ID: 20100771
Other IDs: R01NS072599
Status last verified: Dec 2018
First submitted: 23 Jul 2012
Last updated: 10 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 31377502

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient-Partner Stress Management Effects on CFS Symptoms and Neuroimmune Process
ClinicalTrials.gov ID: NCT01650636
Acronym / sponsor ID: 20100771
Conditions: Chronic Fatigue Syndrome
Keywords: Videophone-delivered stress management intervention, Chronic fatigue syndrome, Symptoms, Neuroimmune processes, Psychosocial
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Oct 2010
Primary completion: May 2017 (actual)
Study completion: May 2017 (actual)
First posted: 26 Jul 2012 (estimated)
Results: Posted 18 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Cognitive Behavioral Stress Management	Experimental	Behavioral: Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)
Health Information	Active comparator	Behavioral: Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)

Who may qualify

Ages: 21 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

men and women diagnosed with chronic fatigue syndrome

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)Ten (10) 90-min sessions of Health Information delivered via videophones	Behavioural	Health Information
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)Ten (10) 90-min sessions of T-PP-CBSM	Behavioural	Cognitive Behavioral Stress Management

Primary outcome

Changes in Frequency and Severity of CDC-based CFS Symptoms
Time frame: baseline and 5 and 9 month post-intervention follow-up
Changes in the average frequency and average severity ratings of CFS symptoms as assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The outcome measure was calculated as a set of two composite scores: 1) Average Symptom Frequency, reflecting an aggregated average of frequency across all symptoms, and 2) Average Symptom Severity, reflecting an aggregated average of severity across all symptoms. Change scores are expressed and calculated as Follow-Up minus Baseline scores for average symptom frequency and average symptom severity.
Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms
Time frame: baseline and 5 and 9 months post-intervention follow-up
Changes in the composite product of average frequency and severity scores of CDC-based CFS symptoms assessed by the CDC Symptom Inventory. Participants rated the frequency (1: A little of the time to 5: All of the time) and severity (1: Very mild to 5: Very severe) of individual CFS symptoms. Greater units on the scale indicate greater symptom frequency or severity. The composite outcome measure was calculated as the product of Average Symptom Frequency and Average Symptom Severity. Change scores are expressed and calculated as Follow-Up minus Baseline scores for the composite product score.

5 secondary outcomes

Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.
Time frame: baseline and 5 and 9 month post-intervention follow-up
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory Cytokines
Time frame: Baseline, 5 months, 9 months
Changes in Neuroimmune Functioning Measured by Anti-inflammatory Cytokines
Time frame: Baseline, 5 months, 9 months
Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokines
Time frame: baseline and 5 and 9 months post-intervention follow-up
Changes in Psychosocial Functioning
Time frame: baseline and 5 and 9 month post-intervention follow-up

Results and safety

Results posted to the registry on 18 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cognitive Behavioral Stress Management	150	150
Health Information	150	150

Primary outcome: Changes in Frequency and Severity of CDC-based CFS Symptoms

Time frame: baseline and 5 and 9 month post-intervention follow-up. Mean (Standard Deviation). Unit: Units on a scale

Measure	Cognitive Behavioral Stress Management n = 75	Health Information n = 75
Average Symptom Frequency Change at 5 months F/U	0.29 (0.77)	0.12 (0.55)
Average Symptom Frequency Change at 9 months F/U	0.49 (0.80)	0.05 (0.67)
Average Symptom Severity Change at 5 months F/U	0.46 (0.76)	0.41 (0.53)
Average Symptom Severity Change at 9 months F/U	0.59 (0.80)	0.34 (0.67)

Population analysed: CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)

Primary outcome: Changes in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms

Time frame: baseline and 5 and 9 months post-intervention follow-up. Mean (Standard Deviation). Unit: Units on a scale

Measure	Cognitive Behavioral Stress Management n = 75	Health Information n = 75
(Frequency * Severity) Change at 5 months F/U	1.65 (3.37)	1.37 (2.38)
(Frequency * Severity) Change at 9 months F/U	2.62 (3.87)	1.10 (3.31)

Population analysed: CFS Patients only were analyzed. (Partner data was not analyzed for this measurement)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event collected for the duration of the study and up to 9 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cognitive Behavioral Stress Management	1 of 150 (0.7%)	0 of 150 (0%)	1 of 150
Health Information	0 of 150 (0%)	2 of 150 (1.3%)	0 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31377502Milrad 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Frequency and Severity of CDC-based CFS Symptoms (time frame: baseline and 5 and 9 month post-intervention follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01650636, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.