| Registry | NCT02447744 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, treatment |
| Enrollment | 43 (Actual) |
| Sponsor | Massachusetts General Hospital (Other); collaborators: Mclean Hospital |
| Conditions | Depression, Anxiety, PTSD, Trauma, Psychological |
| Interventions | Mindfulness based intervention (Behavioral) |
| Dates | start 2014-08-01, primary completion 2016-07-21, completion 2016-07-21, first posted 2015-05-19, last updated 2021-03-23 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Mindfulness group | Experimental | Behavioral: Mindfulness based intervention | This arm receives an 8-week mindfulness based behavioral intervention program. |
| Waitlist control group | Other | Behavioral: Mindfulness based intervention | This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. |
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.
| Milestone | Mindfulness Group | Waitlist Control Group |
|---|---|---|
| Started | 21 | 22 |
| Completed | 15 | 21 |
| Not completed | 6 | 1 |
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.
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Mindfulness Group | 0/21 (0.0%) | 0/21 (0.0%) | 0/21 (0.0%) |
| Waitlist Control Group | 0/22 (0.0%) | 0/22 (0.0%) | 0/22 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Massachusetts General Hospital | Boston, Massachusetts | United States |