Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R21AT005209 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Our uncontrolled study of mindfulness-based stress reduction (MBSR) for urban youth suggests benefits in mental health and quality of life outcomes. To evaluate further the specific effects of MBSR, we are conducting a small randomized controlled trial of the MBSR program compared with a health education program.
A randomized controlled trial will be conducted at two urban clinic sites. HIV-positive youth between the ages of 14 and 22 will be recruited and randomized into either an eight-week (with one retreat session) Mindfulness-Based Stress Reduction (MBSR) course (intervention) or an eight-week (with one retreat session) Healthy Topics (HT) course (active control). Measures of psychological functioning, coping, and life satisfaction will take place at baseline, immediately post-program, and 3-months post program. Medical data, including Cluster of Differentiation 4 (CD4) and viral load counts, will also be collected at the three data collection time points.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | 8-week mindfulness-based stress reduction program with one retreat session |
|
| Healthy Topics | Active Comparator | 8-week health education program with one retreat session - based on a health curriculum developed by McGraw/Hill |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based stress reduction (MBSR) | Behavioral | 8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session. |
| Measure | Description | Time Frame |
|---|---|---|
| Mindful Attention and Awareness Scale (MAAS) |
| assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Life satisfaction was measured with the HIV Quality of Life (QOL) measure, which included three subscales: life satisfaction (range: 1-5), illness burden (range: 1-5) and illness anxiety (range: 1-5). For life satisfaction, higher scores indicated higher satisfaction, and for the other two subscales greater scores indicated more issues with illness burden and illness anxiety. | assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erica M Sibinga, MD, MHS | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins, Harriet Lane Clinic | Baltimore | Maryland | 21287 | United States | ||
| Children's Hospital of Philadelphia, Adolescent Initiative & Special Immunology Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29067834 | Result | Webb L, Perry-Parrish C, Ellen J, Sibinga E. Mindfulness instruction for HIV-infected youth: a randomized controlled trial. AIDS Care. 2018 Jun;30(6):688-695. doi: 10.1080/09540121.2017.1394434. Epub 2017 Oct 25. | |
| 24767265 | Derived | Sibinga EM, Perry-Parrish C, Thorpe K, Mika M, Ellen JM. A small mixed-method RCT of mindfulness instruction for urban youth. Explore (NY). 2014 May-Jun;10(3):180-6. doi: 10.1016/j.explore.2014.02.006. Epub 2014 Feb 25. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
96 individuals consented to study participation and 93 were randomized. However, only 72 were able to be contacted for subsequent baseline data collection.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MBSR Program | mindfulness-based stress reduction program Mindfulness-based stress reduction (MBSR): 8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session. |
| FG001 | HT Program | Health education program. Healthy topics: 8-week health education program with one retreat session |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
96 participants consented; 93 participants were randomized; 72 participants completed baseline data collection
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MBSR Program | mindfulness-based stress reduction program Mindfulness-based stress reduction (MBSR): 8 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice, with one retreat session. |
| BG001 | HT Program |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All study participants were 14-22 years old; however, 17 participants did not report their exact age. 29 participants contributed age data for the MBSR program arm and 26 participants contributed age data for the HT program arm. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mindful Attention and Awareness Scale (MAAS) |
| Posted | Mean | Standard Deviation | units on a scale | assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MBSR Program | mindfulness-based stress reduction program Mindfulness-based stress reduction (MBSR): 9 weekly sessions with instruction designed to enhance mindfulness--mindful meditation, mindful yoga, and discussion of mindfulness practice. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Non-systematic Assessment |
Participant attrition during the study period limited post-intervention data for analysis, although attrition was balanced by study arm, maintaining the balance across study arms.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erica Sibinga | Johns Hopkins School of Medicine | 410-550-4134 | esibinga@jhmi.edu |
Not provided
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Healthy topics | Behavioral | 8 week health education program with one retreat session |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
Health education program. Healthy topics (HT): 8-week health education program with one retreat session |
| BG002 | Total | Total of all reporting groups |
All study participants were 14-22 years old; however, 17 participants did not report their exact age: 9 participants in the MBSR arm, 8 participants in the HT arm. |
| Mean |
| Standard Deviation |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | HT Program | Health education group--8 weekly sessions of age-appropriate health topics. Healthy topics (HT): 8 week health education program |
|
|
| Secondary | Quality of Life | Life satisfaction was measured with the HIV Quality of Life (QOL) measure, which included three subscales: life satisfaction (range: 1-5), illness burden (range: 1-5) and illness anxiety (range: 1-5). For life satisfaction, higher scores indicated higher satisfaction, and for the other two subscales greater scores indicated more issues with illness burden and illness anxiety. | Posted | Mean | Standard Deviation | units on a scale | assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 6 |
| 38 |
| EG001 | HT Program | Health education program Healthy topics: 9 week health education program | 0 | 34 | 0 | 34 | 0 | 34 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Alteration in personality | Psychiatric disorders | Non-systematic Assessment |
|
| General well being | General disorders | Non-systematic Assessment | Fight in school |
|
Not provided
Not provided
| D004191 |
| Behavioral Disciplines and Activities |
| Illness Anxiety |
|