Stress, Psychological
Conditions
Keywords
mindfulness, meditation, urban youth, stress reduction, adolescent, Stress reduction for urban youth
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness-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.
BEHAVIORALHealthy topics
8 week health education program with one retreat session
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 22 Years
Healthy volunteers
Yes
Inclusion criteria
* 14-22 year old youth who receive primary care at the Harriet Lane Clinic or Children's Hospital of Philadelphia.
Exclusion criteria
* Significant developmental, behavioral, substance abuse, or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | * Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness * Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism * Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported | 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. |
Countries
United States
Participant flow
Recruitment details
96 individuals consented to study participation and 93 were randomized. However, only 72 were able to be contacted for subsequent baseline data collection.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 38 |
| HT Program Health education program.
Healthy topics (HT): 8-week health education program with one retreat session | 34 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 28 | 25 |
Baseline characteristics
| Characteristic | MBSR Program | HT Program | Total |
|---|---|---|---|
| Age, Continuous | 18.93 years STANDARD_DEVIATION 2.42 | 18.46 years STANDARD_DEVIATION 2.2 | 18.71 years STANDARD_DEVIATION 2.31 |
| Age, Customized <18 years | 8 Participants | 8 Participants | 16 Participants |
| Age, Customized Between 18 and 65 years | 21 Participants | 18 Participants | 39 Participants |
| Age, Customized Not Reported | 9 Participants | 8 Participants | 17 Participants |
| Region of Enrollment United States | 38 Participants | 34 Participants | 72 Participants |
| Sex/Gender, Customized Female | 16 Participants | 18 Participants | 34 Participants |
| Sex/Gender, Customized Male | 22 Participants | 16 Participants | 38 Participants |
| Sex/Gender, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 34 |
| other Total, other adverse events | 6 / 38 | 0 / 34 |
| serious Total, serious adverse events | 0 / 38 | 0 / 34 |
Outcome results
Primary
Mindful Attention and Awareness Scale (MAAS)
* Mindful Attention and Awareness Scale (MAAS) - measures mindfulness with total score range of 1 - 6, where higher scores indicate greater mindfulness * Children's Response Style Questionnaire(CRSQ) - measures coping mechanisms along three subscales: rumination (range: 0-3), distraction (range: 0-3) and problem-solving (range: 0-3), where higher scores on any of the subscales indicates more frequent use of that type of coping mechanism * Aggression scale - uses total score to measure aggression with a range of 0-6, where higher scores indicated more aggressive behavior
Time frame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Program | Mindful Attention and Awareness Scale (MAAS) | Problem-Solving Coping (CRSQ) | 1.71 units on a scale | Standard Deviation 0.83 |
| MBSR Program | Mindful Attention and Awareness Scale (MAAS) | Distraction (CRSQ) | 1.46 units on a scale | Standard Deviation 0.62 |
| MBSR Program | Mindful Attention and Awareness Scale (MAAS) | Mindfulness (MAAS) | 3.79 units on a scale | Standard Deviation 0.73 |
| MBSR Program | Mindful Attention and Awareness Scale (MAAS) | Aggression | 0.96 units on a scale | Standard Deviation 1.3 |
| MBSR Program | Mindful Attention and Awareness Scale (MAAS) | Rumination (CRSQ) | 1.54 units on a scale | Standard Deviation 0.82 |
| HT Program | Mindful Attention and Awareness Scale (MAAS) | Aggression | 1.44 units on a scale | Standard Deviation 1.21 |
| HT Program | Mindful Attention and Awareness Scale (MAAS) | Problem-Solving Coping (CRSQ) | 1.56 units on a scale | Standard Deviation 0.77 |
| HT Program | Mindful Attention and Awareness Scale (MAAS) | Rumination (CRSQ) | 1.18 units on a scale | Standard Deviation 0.58 |
| HT Program | Mindful Attention and Awareness Scale (MAAS) | Distraction (CRSQ) | 1.37 units on a scale | Standard Deviation 0.73 |
| HT Program | Mindful Attention and Awareness Scale (MAAS) | Mindfulness (MAAS) | 3.66 units on a scale | Standard Deviation 0.88 |
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.
Time frame: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MBSR Program | Quality of Life | Life Satisfaction | 2.22 units on a scale | Standard Deviation 0.74 |
| MBSR Program | Quality of Life | Illness Burden | 1.86 units on a scale | Standard Deviation 0.72 |
| MBSR Program | Quality of Life | Illness Anxiety | 2.38 units on a scale | Standard Deviation 0.78 |
| HT Program | Quality of Life | Life Satisfaction | 1.63 units on a scale | Standard Deviation 0.58 |
| HT Program | Quality of Life | Illness Burden | 1.63 units on a scale | Standard Deviation 0.78 |
| HT Program | Quality of Life | Illness Anxiety | 2.09 units on a scale | Standard Deviation 0.8 |