Trial Outcomes & Findings for Mindfulness for Resilience in Early Life (NCT NCT03633903)

Last Updated: 2021-08-19

Results Overview

Change in level of cortisol in saliva following a social stress test. Subjects completed the Trier Social Stress Test for Children (TSST-C) at baseline and follow-up. The TSST-C consists of public speaking and serial subtraction components in front of two research confederates. The test takes approximately 20 minutes to complete. Salivary cortisol was collected 20 minutes prior to TSST-C, and 20 minutes following the end of the TSST-C, such that the TSST-C task with data collection spanned approximately one hour.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

Results posted on

2021-08-19

Participant Flow

Adolescents and their families were recruited from the community using flyers, radio advertisements, billboards, and a school-based messaging platform (e.g., PeachJar).

Participant milestones

Participant milestones
Measure	Mindfulness Mindfulness: Eight sessions, twice per week over four weeks Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience	Control Treatment as usual, inactive control group
Overall Study STARTED	22	18
Overall Study Intent to Treat	0	18
Overall Study COMPLETED	16	11
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Mindfulness Mindfulness: Eight sessions, twice per week over four weeks Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience	Control Treatment as usual, inactive control group
Overall Study Withdrawal by Subject	1	2
Overall Study Lost to Follow-up	5	5

Baseline Characteristics

Two subjects were removed from analyses due to not beginning intervention or control group.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

Population: Two subjects were removed from all analyses due to not having usable baseline data and withdrawing prior to intervention. One was removed from each group, such than N=22-1=21 analyzed for mindfulness and N=18-1=17 for control.

Outcome measures

Outcome measures
Measure	Mindfulness n=21 Participants Mindfulness: Eight sessions, twice per week over four weeks Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience	Control n=17 Participants Treatment as usual, inactive control group
Cortisol Reactivity follow-up, pre stress induction	-0.21 μg/dL Standard Deviation 1.05	0.34 μg/dL Standard Deviation 0.85
Cortisol Reactivity follow-up, post stress induction	0.05 μg/dL Standard Deviation 1.16	-0.08 μg/dL Standard Deviation 0.76

PRIMARY outcome

Timeframe: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood

Outcome measures

Outcome measures
Measure	Mindfulness n=21 Participants Mindfulness: Eight sessions, twice per week over four weeks Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience	Control n=17 Participants Treatment as usual, inactive control group
Immune System Activity CRP (followup)	0.83 pg/mL; mg/L Standard Deviation 1.45	0.99 pg/mL; mg/L Standard Deviation 1.32
Immune System Activity I'll-6 (followup)	0.46 pg/mL; mg/L Standard Deviation 0.32	0.66 pg/mL; mg/L Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline

Measure Description: We used the Mood and Feelings Questionnaire - Short Form (MFQ-sf) to characterize symptoms of anxiety and depression. The MFQ-sf is a 13-item questionnaire with a simple sum score for the entire scale. Minimum score = 0, maximum score = 26. Scores of 8 or more indicate moderate depression. Codings reflect whether the phrase was descriptive of the subject most of the time, sometimes, or not at all. Higher scores indicate greater symptoms of anxiety/depression, while lower scores indicate less anxiety/depression.

Outcome measures

Outcome measures
Measure	Mindfulness n=21 Participants Mindfulness: Eight sessions, twice per week over four weeks Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience	Control n=17 Participants Treatment as usual, inactive control group
Mood and Feelings Questionnaire	3.82 units on a scale Standard Deviation 4.61	8.17 units on a scale Standard Deviation 8.07

Adverse Events

Mindfulness

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Namik Kirlic, PhD

Laureate Institute for Brain Research

Phone: 918-502-5747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Mindfulness n=22 Participants Mindfulness: Eight sessions, twice per week over four weeks Mindfulness: Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience	Control n=18 Participants Treatment as usual, inactive control group	Total n=40 Participants Total of all reporting groups
Age, Continuous	14.33 years STANDARD_DEVIATION 0.73 • n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	14.29 years STANDARD_DEVIATION 0.77 • n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	14.31 years STANDARD_DEVIATION 0.75 • n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Sex: Female, Male Female	7 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	8 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	15 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Sex: Female, Male Male	14 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	9 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	23 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	1 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	3 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	16 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	35 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	0 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	0 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	2 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	4 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Race (NIH/OMB) Asian	0 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	0 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	0 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	0 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	0 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Race (NIH/OMB) Black or African American	4 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	5 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	9 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Race (NIH/OMB) White	10 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	9 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	19 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Race (NIH/OMB) More than one race	5 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	0 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	5 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=21 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	1 Participants n=17 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.	1 Participants n=38 Participants • Two subjects were removed from analyses due to not beginning intervention or control group.
Change in salivary cortisol baseline, pre stress induction	0.12 μg/dL STANDARD_DEVIATION 0.89 • n=21 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	-0.16 μg/dL STANDARD_DEVIATION 1.15 • n=17 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	-0.02 μg/dL STANDARD_DEVIATION 1.02 • n=38 Participants • Two subjects were removed from analysis due to not beginning intervention or control.
Change in salivary cortisol baseline, post stress induction	-0.22 μg/dL STANDARD_DEVIATION 0.88 • n=21 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	0.27 μg/dL STANDARD_DEVIATION 1.10 • n=17 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	0.025 μg/dL STANDARD_DEVIATION 0.99 • n=38 Participants • Two subjects were removed from analysis due to not beginning intervention or control.
C-reactive protein	1.16 mg/L STANDARD_DEVIATION 3.82 • n=21 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	2.39 mg/L STANDARD_DEVIATION 5.75 • n=17 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	1.775 mg/L STANDARD_DEVIATION 4.785 • n=38 Participants • Two subjects were removed from analysis due to not beginning intervention or control.
Interleukin-6	0.47 pg/mL STANDARD_DEVIATION 0.48 • n=21 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	0.83 pg/mL STANDARD_DEVIATION 1.19 • n=17 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	0.65 pg/mL STANDARD_DEVIATION 0.835 • n=38 Participants • Two subjects were removed from analysis due to not beginning intervention or control.
Depression and Anxiety Symptoms	6.81 units on a scale STANDARD_DEVIATION 4.53 • n=21 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	9.39 units on a scale STANDARD_DEVIATION 6.54 • n=17 Participants • Two subjects were removed from analysis due to not beginning intervention or control.	8.1 units on a scale STANDARD_DEVIATION 5.53 • n=38 Participants • Two subjects were removed from analysis due to not beginning intervention or control.