Trial Outcomes & Findings for Mindfulness-based Stress Reduction for Urban Youth (NCT NCT00661271)

Last Updated: 2018-06-28

Results Overview

* 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

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported

Results posted on

2018-06-28

Participant Flow

96 individuals consented to study participation and 93 were randomized. However, only 72 were able to be contacted for subsequent baseline data collection.

Participant milestones

Participant milestones
Measure	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.	HT Program Health education program. Healthy topics: 8-week health education program with one retreat session
Overall Study STARTED	48	45
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	28	25

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	HT Program Health education program. Healthy topics: 8-week health education program with one retreat session
Overall Study Lost to Follow-up	28	25

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MBSR Program n=38 Participants 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.	HT Program n=34 Participants Health education program. Healthy topics (HT): 8-week health education program with one retreat session	Total n=72 Participants Total of all reporting groups
Age, Continuous	18.93 years STANDARD_DEVIATION 2.42 • n=29 Participants • 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.	18.46 years STANDARD_DEVIATION 2.20 • n=26 Participants • 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.	18.71 years STANDARD_DEVIATION 2.31 • n=55 Participants • 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.
Age, Customized <18 years	8 Participants n=38 Participants	8 Participants n=34 Participants	16 Participants n=72 Participants
Age, Customized Between 18 and 65 years	21 Participants n=38 Participants	18 Participants n=34 Participants	39 Participants n=72 Participants
Age, Customized Not Reported	9 Participants n=38 Participants	8 Participants n=34 Participants	17 Participants n=72 Participants
Sex/Gender, Customized Female	16 Participants n=38 Participants	18 Participants n=34 Participants	34 Participants n=72 Participants
Sex/Gender, Customized Male	22 Participants n=38 Participants	16 Participants n=34 Participants	38 Participants n=72 Participants
Sex/Gender, Customized Not Reported	0 Participants n=38 Participants	0 Participants n=34 Participants	0 Participants n=72 Participants
Region of Enrollment United States	38 Participants n=38 Participants	34 Participants n=34 Participants	72 Participants n=72 Participants

PRIMARY outcome

Timeframe: assessed at Baseline, 3 months follow-up, 4-6 months follow-up; scores at 4-6 month follow-up reported

Outcome measures

Outcome measures
Measure	MBSR Program n=38 Participants 8 week 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.	HT Program n=34 Participants Health education group--8 weekly sessions of age-appropriate health topics. Healthy topics (HT): 8 week health education program
Mindful Attention and Awareness Scale (MAAS) Mindfulness (MAAS)	3.79 units on a scale Standard Deviation 0.73	3.66 units on a scale Standard Deviation 0.88
Mindful Attention and Awareness Scale (MAAS) Problem-Solving Coping (CRSQ)	1.71 units on a scale Standard Deviation 0.83	1.56 units on a scale Standard Deviation 0.77
Mindful Attention and Awareness Scale (MAAS) Rumination (CRSQ)	1.54 units on a scale Standard Deviation 0.82	1.18 units on a scale Standard Deviation 0.58
Mindful Attention and Awareness Scale (MAAS) Distraction (CRSQ)	1.46 units on a scale Standard Deviation 0.62	1.37 units on a scale Standard Deviation 0.73
Mindful Attention and Awareness Scale (MAAS) Aggression	0.96 units on a scale Standard Deviation 1.30	1.44 units on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	MBSR Program n=38 Participants 8 week 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.	HT Program n=34 Participants Health education group--8 weekly sessions of age-appropriate health topics. Healthy topics (HT): 8 week health education program
Quality of Life Life Satisfaction	2.22 units on a scale Standard Deviation 0.74	1.63 units on a scale Standard Deviation 0.58
Quality of Life Illness Burden	1.86 units on a scale Standard Deviation 0.72	1.63 units on a scale Standard Deviation 0.78
Quality of Life Illness Anxiety	2.38 units on a scale Standard Deviation 0.78	2.09 units on a scale Standard Deviation 0.80

Adverse Events

MBSR Program

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

HT Program

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MBSR Program n=38 participants at risk 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.	HT Program n=34 participants at risk Health education program Healthy topics: 9 week health education program
General disorders Headache	7.9% 3/38 • Number of events 3	0.00% 0/34
Gastrointestinal disorders Nausea	5.3% 2/38 • Number of events 3	0.00% 0/34
General disorders Fatigue	2.6% 1/38 • Number of events 1	0.00% 0/34
Psychiatric disorders Alteration in personality	2.6% 1/38 • Number of events 1	0.00% 0/34
General disorders General well being	2.6% 1/38 • Number of events 1	0.00% 0/34

Additional Information

Erica Sibinga

Johns Hopkins School of Medicine

Phone: 410-550-4134

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place