Chronic Illness Clinical Trial
Official title:
Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study
NCT number | NCT03170167 |
Other study ID # | 13-11679 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 2016 |
Est. completion date | June 30, 2020 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 20 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Osher Center for Integrative Medicine | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Physical wellbeing | NIH Promis Global Health instrument summary score | Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months | |
Primary | Mental wellbeing | NIH Promis Global Health instrument summary score | Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months | |
Primary | Perceived Stress | Perceived stress scale summary score | Change from baseline Perceived stress scale summary score at 2 months, and at 5 months | |
Primary | Mood: Tension | Profile of Mood States Tension instrument subscale score | Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months | |
Primary | Resilience | 14-Item Resilience Scale summary score | Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months | |
Primary | Social support | Social Support Scale summary score | Change from baseline Social Support Scale summary score at 2 months, and at 5 months | |
Primary | Mindfulness | Mindful Attention Awareness Scale summary score | Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months | |
Primary | Mood: Anger | Profile of Mood States Anger instrument subscale score | Change from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 months | |
Primary | Mood: Depression | Profile of Mood States Depression instrument subscale score | Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months | |
Primary | Mood: Fatigue | Profile of Mood States Fatigue instrument subscale score | Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months | |
Secondary | Self-reported adherence, using Medical Outcomes Study General Adherence scale | Medical Outcomes Study General Adherence instrument summary score | Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months | |
Secondary | pain medicine usage in past month | likert scale | Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months | |
Secondary | 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 |
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