Marriott 2016.
Study name | The better resiliency among veterans with omega‐3's study (BRAVO) |
Methods | Randomised placebo‐controlled trial, 6 months |
Participants | Participants: Veteran or non‐veteran identified as being at risk for suicide and presently under the care of a mental healthcare provider (a release of information from his/her mental healthcare provider is required.); age 18 ‐ 90; within the participant's medical history, either a suicide attempt in the last 6 months, or a suicide attempt during the adult lifetime AND current diagnosis of an episode of depression as diagnosed on the Mini International Neuropsychiatric Interview (MINI), or an inpatient admission with suicide risk in the last 6 months, or an inpatient admission with suicide risk during the adult lifetime AND current diagnosis of an episode of depression as diagnosed on the Mini International Neuropsychiatric Interview (MINI), or positive suicidal behaviour or ideation based on a psychiatrist‐ administered Columbia‐Suicide Severity Rating Scale (C‐SSRS) and psychiatrist review of participant medical history and physical, or a score of 0 or greater on the Implicit Associations Test‐Suicide (IAT‐S), or > or 9 on the Beck Hopelessness Scale (BHS) and psychiatrist review of participant medical history and physical; participant can safely eat walnuts, pecans, almonds, peanuts and all other nuts, apples, peaches, pears, pomegranates, aronia, jackfruit, and passion fruit, the herb rosemary, and the fish salmon, trout and cod, drink and eat food that contain whey or milk protein, or both, willingness to drink the juice boxes 3 times each day for 6 months, have a stable residence with adequate space to store the juice, and capacity to provide written informed consent. Additional inclusion criteria for Depressive Symptoms sub‐analysis: enrolment in the primary study of suicide risk reduction; a Beck Depression Inventory ≥ 30; a diagnosis of a depressive disorder Actual enrolment reported as 125 participants (March 2014 ‐ August 2016) |
Interventions | Intervention: 550 mg EPA + 550 mg DHA, provided as a fruit juice/smoothie, 3 times a day, to result in a dose of 1650 mg EPA and 1650 mg DHA / day Comparator: Fruit juice including 1100 mg macadamia oil, 3 times a day |
Outcomes | Primary: Suicadal behaviours and thinking, at months 1, 3, 5 and 6 Secondary: Symptoms associated with suicidal risk, associated with negative affect, PTSD and cognitive functioning, at months 1, 3, 5 and 6 |
Starting date | March 2014 |
Contact information | Bernadette Marriott, PhD, Medical University of South Carolina, USA |
Notes | Clinical Trials: ID: NCT01901887 |