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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01650636
Enrollment
300
Registered
2012-07-26
Start date
2010-10-31
Completion date
2017-05-31
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome

Keywords

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

Brief summary

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

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.

Interventions

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

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

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

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

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in Frequency and Severity of CDC-based CFS Symptomsbaseline and 5 and 9 month post-intervention follow-upChanges 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 Symptomsbaseline and 5 and 9 months post-intervention follow-upChanges 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.

Secondary

MeasureTime frameDescription
Changes in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesBaseline, 5 months, 9 monthsSerum 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).
Changes in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.baseline and 5 and 9 month post-intervention follow-upChanges 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).
Changes in Psychosocial Functioningbaseline and 5 and 9 month post-intervention follow-upChanges 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.
Changes in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory Cytokinesbaseline and 5 and 9 months post-intervention follow-upSerum 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).
Changes in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesBaseline, 5 months, 9 monthsSerum 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).

Countries

United States

Participant flow

Recruitment details

Chronic Fatigue Syndrome (CFS) and their partners were recruited from CFS physicians clinics and community.

Participants by arm

ArmCount
Cognitive Behavioral Stress Management
Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM): Ten (10) 90-min sessions of T-PP-CBSM
150
Health Information
Patient-Partner Videotelephone-delivered Health Information (PP-T-HI): Ten (10) 90-min sessions of Health Information delivered via videophones
150
Total300

Withdrawals & dropouts

PeriodReasonFG000FG001
Washout up to 5 MonthsDeath10
Washout up to 5 MonthsLost to Follow-up28
Washout up to 5 MonthsPhysician Decision22
Washout up to 5 MonthsWithdrawal by Subject48
Washout up to 9 MonthsLost to Follow-up21
Washout up to 9 MonthsWithdrawal by Subject42

Baseline characteristics

CharacteristicTotalCognitive Behavioral Stress ManagementHealth Information
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
22 Participants12 Participants10 Participants
Age, Categorical
Between 18 and 65 years
278 Participants138 Participants140 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
86 Participants37 Participants49 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
214 Participants113 Participants101 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
3 Participants2 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
294 Participants148 Participants146 Participants
Sex: Female, Male
Female
158 Participants78 Participants80 Participants
Sex: Female, Male
Male
142 Participants72 Participants70 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 1500 / 150
other
Total, other adverse events
0 / 1502 / 150
serious
Total, serious adverse events
1 / 1500 / 150

Outcome results

Primary

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.

Time frame: baseline and 5 and 9 months post-intervention follow-up

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

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Stress ManagementChanges in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms(Frequency * Severity) Change at 5 months F/U1.65 Units on a scaleStandard Deviation 3.37
Cognitive Behavioral Stress ManagementChanges in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms(Frequency * Severity) Change at 9 months F/U2.62 Units on a scaleStandard Deviation 3.87
Health InformationChanges in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms(Frequency * Severity) Change at 5 months F/U1.37 Units on a scaleStandard Deviation 2.38
Health InformationChanges in a Single Composite Product of Average Frequency and Severity Scores of CDC-based CFS Symptoms(Frequency * Severity) Change at 9 months F/U1.10 Units on a scaleStandard Deviation 3.31
Primary

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.

Time frame: baseline and 5 and 9 month post-intervention follow-up

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

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Stress ManagementChanges in Frequency and Severity of CDC-based CFS SymptomsAverage Symptom Frequency Change at 5 months F/U0.29 Units on a scaleStandard Deviation 0.77
Cognitive Behavioral Stress ManagementChanges in Frequency and Severity of CDC-based CFS SymptomsAverage Symptom Frequency Change at 9 months F/U0.49 Units on a scaleStandard Deviation 0.8
Cognitive Behavioral Stress ManagementChanges in Frequency and Severity of CDC-based CFS SymptomsAverage Symptom Severity Change at 5 months F/U0.46 Units on a scaleStandard Deviation 0.76
Cognitive Behavioral Stress ManagementChanges in Frequency and Severity of CDC-based CFS SymptomsAverage Symptom Severity Change at 9 months F/U0.59 Units on a scaleStandard Deviation 0.8
Health InformationChanges in Frequency and Severity of CDC-based CFS SymptomsAverage Symptom Severity Change at 9 months F/U0.34 Units on a scaleStandard Deviation 0.67
Health InformationChanges in Frequency and Severity of CDC-based CFS SymptomsAverage Symptom Frequency Change at 5 months F/U0.12 Units on a scaleStandard Deviation 0.55
Health InformationChanges in Frequency and Severity of CDC-based CFS SymptomsAverage Symptom Severity Change at 5 months F/U0.41 Units on a scaleStandard Deviation 0.53
Health InformationChanges in Frequency and Severity of CDC-based CFS SymptomsAverage Symptom Frequency Change at 9 months F/U0.05 Units on a scaleStandard Deviation 0.67
Secondary

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).

Time frame: Baseline, 5 months, 9 months

Population: Only CFS Patients were analyzed. Partner data was not collected for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-4 Change at 5 months F/U0.61 pg/mLStandard Deviation 3.93
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-4 Change at 9 months F/U-0.06 pg/mLStandard Deviation 3.09
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-5 Change at 5 months F/U-0.42 pg/mLStandard Deviation 3.26
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-5 Change at 9 months F/U-1.05 pg/mLStandard Deviation 4.73
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-10 Change at 5 months F/U-1.02 pg/mLStandard Deviation 10.53
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-10 Change at 9 months F/U1.01 pg/mLStandard Deviation 10.9
Health InformationChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-10 Change at 5 months F/U-0.77 pg/mLStandard Deviation 10.3
Health InformationChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-4 Change at 5 months F/U0.54 pg/mLStandard Deviation 3.03
Health InformationChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-5 Change at 9 months F/U-0.55 pg/mLStandard Deviation 3.99
Health InformationChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-4 Change at 9 months F/U0.37 pg/mLStandard Deviation 2.27
Health InformationChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-10 Change at 9 months F/U2.67 pg/mLStandard Deviation 26.26
Health InformationChanges in Neuroimmune Functioning Measured by Anti-inflammatory CytokinesIL-5 Change at 5 months F/U-0.23 pg/mLStandard Deviation 4.28
Secondary

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).

Time frame: baseline and 5 and 9 month post-intervention follow-up

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

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.Change at 5 months F/U0.24 Ug/dLStandard Deviation 1.19
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.Change at 9 months F/U0.08 Ug/dLStandard Deviation 1.19
Health InformationChanges in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.Change at 5 months F/U-0.06 Ug/dLStandard Deviation 1.25
Health InformationChanges in Neuroimmune Functioning Measured by Change in Averaged (2-day) Di-urnal Slope of Salivary Cortisol.Change at 9 months F/U0.31 Ug/dLStandard Deviation 1.86
Secondary

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).

Time frame: Baseline, 5 months, 9 months

Population: CFS Patients Only were analyzed. Data for this outcome measure were not collected from partners.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesIL-1a Change at 5 months F/U0.39 pg/mLStandard Deviation 8.25
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesIL-1a Change at 9 months F/U0.42 pg/mLStandard Deviation 6.68
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesIL-6 Change at 5 months F/U0.84 pg/mLStandard Deviation 6.88
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesIL-6 Change at 9 months F/U0.43 pg/mLStandard Deviation 3.61
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesTNFa Change at 5 months F/U-1.34 pg/mLStandard Deviation 15.86
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesTNFa Change at 9 months F/U-2.52 pg/mLStandard Deviation 14.86
Health InformationChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesTNFa Change at 5 months F/U4.28 pg/mLStandard Deviation 19.64
Health InformationChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesIL-1a Change at 5 months F/U0.10 pg/mLStandard Deviation 8.33
Health InformationChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesIL-6 Change at 9 months F/U-0.30 pg/mLStandard Deviation 5.36
Health InformationChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesIL-1a Change at 9 months F/U-0.32 pg/mLStandard Deviation 7.27
Health InformationChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesTNFa Change at 9 months F/U-1.05 pg/mLStandard Deviation 22.87
Health InformationChanges in Neuroimmune Functioning Measured by Pro-Inflammatory CytokinesIL-6 Change at 5 months F/U-0.59 pg/mLStandard Deviation 5.09
Secondary

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).

Time frame: baseline and 5 and 9 months post-intervention follow-up

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

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory CytokinesRatio Change at 9 months F/U0.23 RatioStandard Deviation 6.98
Cognitive Behavioral Stress ManagementChanges in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory CytokinesRatio Change at 5 months F/U-0.43 RatioStandard Deviation 5.28
Health InformationChanges in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory CytokinesRatio Change at 5 months F/U-0.38 RatioStandard Deviation 8.55
Health InformationChanges in Neuroimmune Regulation Measured by Ratio of Pro-Inflammatory to Anti-Inflammatory CytokinesRatio Change at 9 months F/U-1.14 RatioStandard Deviation 13.73
Secondary

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.

Time frame: baseline and 5 and 9 month post-intervention follow-up

Population: Only CFS Patient's data were analyzed. Partner data was not collected for this outcome measure.

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive Behavioral Stress ManagementChanges in Psychosocial FunctioningPSS Change at 5 months F/U-2.57 Units on a scaleStandard Deviation 8.17
Cognitive Behavioral Stress ManagementChanges in Psychosocial FunctioningCES-D Change at 5 months F/U-0.44 Units on a scaleStandard Deviation 10.67
Cognitive Behavioral Stress ManagementChanges in Psychosocial FunctioningSIP Recreation and Pastimes Change at 9 months F/U-0.23 Units on a scaleStandard Deviation 3.32
Cognitive Behavioral Stress ManagementChanges in Psychosocial FunctioningPSS Change at 9 months F/U-0.56 Units on a scaleStandard Deviation 9.07
Cognitive Behavioral Stress ManagementChanges in Psychosocial FunctioningSIP Social Interaction Change at 5 months F/U0.95 Units on a scaleStandard Deviation 3.78
Cognitive Behavioral Stress ManagementChanges in Psychosocial FunctioningCES-D Change at 9 months F/U1.66 Units on a scaleStandard Deviation 12.2
Cognitive Behavioral Stress ManagementChanges in Psychosocial FunctioningSIP Social Interaction Change at 9 months F/U0.23 Units on a scaleStandard Deviation 3.32
Cognitive Behavioral Stress ManagementChanges in Psychosocial FunctioningSIP Recreation and Pastimes Change at 5 months F/U-0.95 Units on a scaleStandard Deviation 3.78
Health InformationChanges in Psychosocial FunctioningSIP Social Interaction Change at 9 months F/U0.70 Units on a scaleStandard Deviation 3.5
Health InformationChanges in Psychosocial FunctioningPSS Change at 5 months F/U-2.84 Units on a scaleStandard Deviation 7.39
Health InformationChanges in Psychosocial FunctioningPSS Change at 9 months F/U-3.28 Units on a scaleStandard Deviation 8.3
Health InformationChanges in Psychosocial FunctioningCES-D Change at 5 months F/U-1.36 Units on a scaleStandard Deviation 10.18
Health InformationChanges in Psychosocial FunctioningCES-D Change at 9 months F/U-3.08 Units on a scaleStandard Deviation 11.21
Health InformationChanges in Psychosocial FunctioningSIP Recreation and Pastimes Change at 5 months F/U-0.98 Units on a scaleStandard Deviation 2.8
Health InformationChanges in Psychosocial FunctioningSIP Recreation and Pastimes Change at 9 months F/U-0.70 Units on a scaleStandard Deviation 3.5
Health InformationChanges in Psychosocial FunctioningSIP Social Interaction Change at 5 months F/U0.98 Units on a scaleStandard Deviation 2.8

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026