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| Name | Class |
|---|---|
| Oklahoma State University | OTHER |
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Early life stress (ELS) is associated with a number of psychiatric and medical conditions later in life, thought to be caused by subsequent disruptions in biological processes involved in regulation of stress responses. Given that these alterations have long-lasting effects, there is a great need for effective preventative interventions. The long-term goal of this project is to identify early interventions that may most powerfully mitigate risk for psychiatric illness among adolescents with exposure to early life stress (ELS), with a focus on interventions that can be widely and effectively implemented, have the potential for long-lasting benefits, and can effectively engage targeted neurobiological processes and networks. The specific aims of the present study are to 1) examine how ELS impacts biological processes associated with regulation of stress, and 2) identify how MBI impacts affective symptoms and biological processes dysregulated by ELS.
This study supports the efforts to reduce the effects of early adversity in children by testing an impact of an effective psychological intervention on disrupted biological processes caused by early adversity. Successful achievement of the proposed aims will contribute to a) the knowledge base needed to reduce the effects of trauma and stress in children and families and b) the development of easily implemented and disseminated preventative interventions.
The proposed study will utilize a multi-method design to examine the effect of mindfulness on biological processes (i.e., stress responses) disrupted by exposure to ELS among adolescents age 13 to 15. Adolescents will first complete self-report measures of childhood adverse experiences, trauma, and neglect. Forty eligible adolescents will be next randomly assigned to either an eight session mindfulness-based stress reduction intervention for teens or no treatment. Pre- and post-intervention assessment will include (a) self-report measures of symptoms and emotion regulation, (b) a blood draw for assessment of inflammatory markers and gene expression, and (c) a stress task with saliva cortisol collected before and after this task.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Active Comparator | Mindfulness: Eight sessions, twice per week over four weeks. Surveys administered prior to each session. |
|
| Control | No Intervention | Treatment as usual (i.e., pharmacotherapy, psychotherapy, etc.) for the four week duration with twice weekly surveys administered. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cortisol Reactivity | 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. | Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline |
| Immune System Activity | Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood | Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mood and Feelings Questionnaire | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Namik Kirlic, PhD | Laureate Institute for Brain Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laureate Institute for Brain Research | Tulsa | Oklahoma | 74136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33858395 | Derived | Cohen ZP, Cosgrove KT, Akeman E, Coffey S, Teague K, Hays-Grudo J, Paulus MP, Aupperle RL, Kirlic N. The effect of a mindfulness-based stress intervention on neurobiological and symptom measures in adolescents with early life stress: a randomized feasibility study. BMC Complement Med Ther. 2021 Apr 15;21(1):123. doi: 10.1186/s12906-021-03295-1. |
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Adolescents and their families were recruited from the community using flyers, radio advertisements, billboards, and a school-based messaging platform (e.g., PeachJar).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control | Treatment as usual, inactive control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Two subjects were removed from analyses due to not beginning intervention or control group. |
| 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 | Cortisol Reactivity | 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. | 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. | Posted | Mean | Standard Deviation | μg/dL | Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline |
|
Adverse events were monitored throughout baseline (T1), 8 sessions of twice-weekly intervention where survey responses were recorded and the MBSR-T group had group intervention (T2-T9), and follow-up (T10).
No adverse events were reported or observed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Namik Kirlic, PhD | Laureate Institute for Brain Research | 918-502-5747 | nkirlic@laureateinstitute.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2018 | Jun 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Adolescents are randomly assigned to either a mindfulness intervention or no intervention.
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| Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline |
Treatment as usual, inactive control group |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Two subjects were removed from analyses due to not beginning intervention or control group. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Two subjects were removed from analyses due to not beginning intervention or control group. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Two subjects were removed from analyses due to not beginning intervention or control group. | Count of Participants | Participants |
|
| Change in salivary cortisol | This measure is the change in cortisol from the stress induction task. Salivary cortisol was collected 20 minutes before and 20 minutes after stress induction. For analyses, we subtracted post minus pre cortisol levels, such that negative values are possible if post stress induction cortisol was lower than pre stress induction cortisol. | Two subjects were removed from analysis due to not beginning intervention or control. | Mean | Standard Deviation | μg/dL |
|
| C-reactive protein | Two subjects were removed from analysis due to not beginning intervention or control. | Mean | Standard Deviation | mg/L |
|
| Interleukin-6 | Two subjects were removed from analysis due to not beginning intervention or control. | Mean | Standard Deviation | pg/mL |
|
| Depression and Anxiety Symptoms | 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. | Two subjects were removed from analysis due to not beginning intervention or control. | Mean | Standard Deviation | units on a scale |
|
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
| OG001 | Control | Treatment as usual, inactive control group |
|
|
|
| Primary | Immune System Activity | Change in level of interleukin 6 (IL-6) and C-reactive protein (CRP) in blood | 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. | Posted | Mean | Standard Deviation | pg/mL; mg/L | Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline |
|
|
|
|
| Secondary | Mood and Feelings Questionnaire | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control | Treatment as usual, inactive control group | 0 | 18 | 0 | 18 | 0 | 18 |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mixed Models Analysis |
| .95 |
| Mean Difference (Final Values) |
| -0.02 |
| 2-Sided |
| Superiority |