TrialReader


Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment

NCT02447744 — Not applicable, Completed, 43 participants, Massachusetts General Hospital

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RegistryNCT02447744
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment43 (Actual)
SponsorMassachusetts General Hospital (Other); collaborators: Mclean Hospital
ConditionsDepression, Anxiety, PTSD, Trauma, Psychological
InterventionsMindfulness based intervention (Behavioral)
Datesstart 2014-08-01, primary completion 2016-07-21, completion 2016-07-21, first posted 2015-05-19, last updated 2021-03-23
Locations1 site in United States

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-Summary

Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.

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+Detailed description

This study recruits young adults with childhood adversity; enrolled subjects either receive an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the intervention. MRI and a battery of self report questionnaires will be administered before and after the intervention; subjects on the waiting list will undergo the same research procedures at the same time as subjects in the intervention group. Primary hypotheses include improved hippocampal plasticity, increased mindfulness and reduced stress and related psychological symptoms.

+Arms and interventions

ArmTypeInterventionsDescription
Mindfulness groupExperimentalBehavioral: Mindfulness based interventionThis arm receives an 8-week mindfulness based behavioral intervention program.
Waitlist control groupOtherBehavioral: Mindfulness based interventionThis arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.
  • Mindfulness based intervention (Behavioral): The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.

+Outcome measures

Primary outcomes

  • Changes in Subjects' Perceived Stress Level [After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.]: Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed.

Secondary outcomes

  • Changes of Mindfulness [After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.]: Changes in the mindfulness level as measured by the Mindful Attention Awareness Scale (post-intervention scores minus pre-intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The MAAS is a 15-item scale each responded with Likert scale 1-6; the MAAS score calculated as the mean of all items, thus the full range of the score is 1-6, with higher scores meaning more mindful. An increase in MAAS score (i.e., a positive score change )means the subject has improved after the intervention by becoming more mindful.

+Eligibility

Sex: All, ages: 19 Years to 35 Years, accepts healthy volunteers

Inclusion Criteria:

* Experience of childhood maltreatment
* With current age between 19 to 35 years old
* With current symptoms of depression or anxiety or PTSD or significant general stress.

Exclusion Criteria:

* History of psychiatric disorders with psychotic features
* Suicidal attempts during the past six months
* Neurological disorders
* And common MRI exclusion criteria
* Prior history with the mindfulness based stress reduction program or other systematic meditation programs.

+Posted results

Participant flow

MilestoneMindfulness GroupWaitlist Control Group
Started2122
Completed1521
Not completed61

Outcome results

  • Changes in Subjects' Perceived Stress Level (Primary), Mean, score on a scale: Mindfulness Group -5.526 +/- 1.566; Waitlist Control Group 1.000 +/- 1.437
  • Changes of Mindfulness (Secondary), Mean, score on a scale: Mindfulness Group 0.337 +/- 0.149; Waitlist Control Group 0.049 +/- 0.126
  • Percent Changes of Right Hippocampal Grey Matter Density (Post hoc), Mean, Percent change: Mindfulness Group 0.8137 +/- 0.3143; Waitlist Control Group -0.9229 +/- 0.2014

Adverse events

Time frame: Adverse event data were collected between the period of time when subjects are enrolled in the study and when subjects complete the post-intervention research procedures, or till subjects voluntarily drop out of the study before the completion of intervention and research procedures. The time frame is up to 2 years.

ArmDeathsSerious adverse eventsOther adverse events
Mindfulness Group0/21 (0.0%)0/21 (0.0%)0/21 (0.0%)
Waitlist Control Group0/22 (0.0%)0/22 (0.0%)0/22 (0.0%)

+Locations (1)

FacilityCityCountryStatus
Massachusetts General HospitalBoston, MassachusettsUnited States

+Publications

  • Results publication: Joss D, Khan A, Lazar SW, Teicher MH. Effects of a Mindfulness-Based Intervention on Self-Compassion and Psychological Health Among Young Adults With a History of Childhood Maltreatment. Front Psychol. 2019 Oct 23;10:2373. doi: 10.3389/fpsyg.2019.02373. eCollection 2019. PMID 31749731

+Investigators

My Notes