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Clinical Trials/NCT03170167
NCT03170167
Unknown
Not Applicable

Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study

University of California, San Francisco1 site in 1 country100 target enrollmentOctober 2016
ConditionsChronic Illness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Illness
Sponsor
University of California, San Francisco
Enrollment
100
Locations
1
Primary Endpoint
Mental wellbeing
Last Updated
7 years ago

Overview

Brief Summary

The proposed pilot study is an evaluation of Communitas, a mind-body skills group visit and for 12-19 year-olds living with chronic physical illness. The goal of this study is to assess the efficacy and feasibility of these group visits. During 2017-2018, the investigators will recruit 50-100 patient and 50-100 parent enrollees of Communitas to participate in this study. The study will be a pre-post evaluation, without a control group, using validated patient-report assessments at baseline, after completion of the group visits, and 3 months later. The primary outcome variables will be physical and mental wellbeing, stress, mood, resilience, mindfulness, and social support. Paired t tests will be used to assess changes from baseline to immediately post-intervention & 3 months post-intervention. The investigators will also calculate Cohen's d effect sizes, to help them understand the degree to which an effect is present in the population.

Detailed Description

The Communitas pilot study is a survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. The goal of this study is to evaluate the preliminary efficacy and feasibility for these group visits. Approximately 50-100 patients and 50-100 parent enrollees of the Communitas group visits will be recruited to participate in this survey study optionally. During the group visits, both the patient and parent groups will learn about and experience various coping, self-care, pain and stress-reduction modalities, participate in group sharing to promote engagement with a diagnosis and provide emotional support, and benefit from facilitated discussions about some of the more practical aspects of living with chronic illness. The group visits will be offered to patients and their parents as clinical service, regardless of enrollment in the survey study, and will be billed to insurance as consult group visit with the pediatrician. The group visits will be held at both the Osher Center for Integrative Medicine and Mission Bay Children's Hospital and will be led by a pediatrician, starting in October 2016. The study will be set up as a pre-post evaluation, without a control group, using patient-report and parent-report qualitative and quantitative assessments at baseline, after completion of the series of group visits, and 3 months later. In addition, some families may be asked if they would like to participate in a videotaped interview before and after the start of the program.

Registry
clinicaltrials.gov
Start Date
October 2016
End Date
June 30, 2020
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rick Hecht

Research Director of the Osher Center, and Professor of Medicine at UCSF

University of California, San Francisco

Eligibility Criteria

Inclusion Criteria

  • Enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital.
  • Patients enrolled in these group visits are males and females 12-20 years of age and living with a chronic illness.

Exclusion Criteria

  • People who are not enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital will be excluded from this survey study.
  • The Communitas group consists of a patient group of young people ages 12-20 living with chronic illness, as well as a parent group.

Outcomes

Primary Outcomes

Mental wellbeing

Time Frame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months

NIH Promis Global Health instrument summary score

Mood: Fatigue

Time Frame: Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months

Profile of Mood States Fatigue instrument subscale score

Mood: Tension

Time Frame: Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months

Profile of Mood States Tension instrument subscale score

Resilience

Time Frame: Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months

14-Item Resilience Scale summary score

Social support

Time Frame: Change from baseline Social Support Scale summary score at 2 months, and at 5 months

Social Support Scale summary score

Physical wellbeing

Time Frame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months

NIH Promis Global Health instrument summary score

Perceived Stress

Time Frame: Change from baseline Perceived stress scale summary score at 2 months, and at 5 months

Perceived stress scale summary score

Mindfulness

Time Frame: Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months

Mindful Attention Awareness Scale summary score

Mood: Anger

Time Frame: Change from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 months

Profile of Mood States Anger instrument subscale score

Mood: Depression

Time Frame: Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months

Profile of Mood States Depression instrument subscale score

Secondary Outcomes

  • number visits to emergency department in past month(Change from baseline number visits to emergency department in past month at 2 months, and at 5 months)
  • Self-reported adherence, using Medical Outcomes Study General Adherence scale(Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months)
  • pain medicine usage in past month(Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months)

Study Sites (1)

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