Chronic IllnessNCT03170167
Communitas: A Program for Teens Living With Chronic Illness and Their Families
An observational study of Chronic Illness, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Chronic Illness
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 4 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 12-20 year-old pediatric patients who are living with a chronic physical illness and who are enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital, along with their willing and available guardian(s).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Medicine
San Francisco, California, 94115
About this study
Official title: Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study
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.
Read the 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.
- Conditions
- Chronic Illness
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | This is a pre-post survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. Approximately 50-100 patient enrollees of the Communitas group visits will be recruited to participate in this survey study optionally. | |
| Parents | This is a pre-post survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. Approximately 50-100 parent enrollees of the Communitas group visits will be recruited to participate in this survey study optionally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical wellbeing
NIH Promis Global Health instrument summary score
Measured: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
Mental wellbeing
NIH Promis Global Health instrument summary score
Measured: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months
Perceived Stress
Perceived stress scale summary score
Measured: Change from baseline Perceived stress scale summary score at 2 months, and at 5 months
Mood: Tension
Profile of Mood States Tension instrument subscale score
Measured: Change from baseline Profile of Mood States Tension instrument subscale score at 2 months and at 5 months
Resilience
14-Item Resilience Scale summary score
Measured: Change from baseline 14-Item Resilience Scale summary score at 2 months and at 5 months
Social support
Social Support Scale summary score
Measured: Change from baseline Social Support Scale summary score at 2 months, and at 5 months
Mindfulness
Mindful Attention Awareness Scale summary score
Measured: Change from baseline Mindful Attention Awareness Scale summary score at 2 months, and at 5 months
Mood: Anger
Profile of Mood States Anger instrument subscale score
Measured: Change from baseline Profile of Mood States Anger instrument sub scale score at 2 months, and at 5 months
Mood: Depression
Profile of Mood States Depression instrument subscale score
Measured: Change from baseline Profile of Mood States Depression instrument sub scale score at 2 months, and at 5 months
Mood: Fatigue
Profile of Mood States Fatigue instrument subscale score
Measured: Change from baseline Profile of Mood States Fatigue instrument sub scale score at 2 months, and at 5 months
Secondary outcomes (3)
Self-reported adherence, using Medical Outcomes Study General Adherence scale
Medical Outcomes Study General Adherence instrument summary score
Measured: Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months
pain medicine usage in past month
likert scale
Measured: Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months
number visits to emergency department in past month
Measured: Change from baseline number visits to emergency department in past month at 2 months, and at 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study startOct 2016
- Primary completion4 Sep 2019
- Study completion4 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frederick M Hecht, MD, Principal investigator, UCSF Osher Center for Integrative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170167
- Sponsor's protocol ID
- 13-11679
- Status last verified
- Aug 2026
- First submitted
- 18 Oct 2016
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mind-Body and Peer Support Program for Teens Living With Chronic Illness and Their Parents: A Pilot Study
- ClinicalTrials.gov ID
- NCT03170167
- Acronym / sponsor ID
- 13-11679
- Conditions
- Chronic Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 4 Sep 2019 (actual)
- Study completion
- 4 Sep 2019 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –This is a pre-post survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. Approximately 50-100 patient enrollees of the Communitas group visits will be recruited to participate in this survey study optionally. |
| Parents | – | –This is a pre-post survey study of Communitas, a pre-existing integrative medicine and mind-body skills group visit for adolescents living with chronic illness and their parents. Approximately 50-100 parent enrollees of the Communitas group visits will be recruited to participate in this survey study optionally. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 12-20 year-old pediatric patients who are living with a chronic physical illness and who are enrolled in the Communitas group visit at the UCSF Osher Center for Integrative Medicine or Mission Bay Children's Hospital, along with their willing and available guardian(s).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Perceived Stress
Time frame: Change from baseline Perceived stress scale summary score at 2 months, and at 5 months
Perceived stress scale summary 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
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
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
3 secondary outcomes
Self-reported adherence, using Medical Outcomes Study General Adherence scale
Time frame: Change from baseline Medical Outcomes Study General Adherence instrument summary score at 2 months, and at 5 months
pain medicine usage in past month
Time frame: Change from baseline pain medicine usage in past month likert scale at 2 months, and at 5 months
number visits to emergency department in past month
Time frame: Change from baseline number visits to emergency department in past month at 2 months, and at 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
Frederick M Hecht, MD principal investigator
UCSF Osher Center for Integrative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Illness, run by University of California, San Francisco at 1 site in United States.
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 2 inclusion and 2 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 1 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical wellbeing (time frame: Change from baseline NIH Promis Global Health instrument summary score at 2 months and at 5 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2026.