Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
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Psychiatric Symptoms in Survivors of Acute Respiratory Distress Syndrome. Effects of Age, Sex, and Immune Modulation.

RATIONALE: Psychiatric morbidity after acute respiratory distress syndrome (ARDS) is common, and our current ability to predict psychiatric symptoms based on patient- and illness-specific factors is limited.

OBJECTIVES: We assessed symptoms of anxiety, depression, and posttraumatic stress disorder (PTSD) in long-term survivors of ARDS, as well as the associated changes in cortisol levels.

METHODS: The participants were enrolled in a randomized, double-blind, placebo-controlled trial of granulocyte macrophage-colony stimulating factor (GM-CSF) or placebo conducted at three academic medical centers. There were 132 patients enrolled, and 44 patients completed 6-month follow-up questionnaires (45% of survivors).

RESULTS: Six months after enrollment, survivors completed the Post-Traumatic Stress Syndrome 10 Questions Inventory, Impact of Event Scale, and Hospital Anxiety and Depression Scale to assess psychiatric symptoms. Plasma cortisol levels during treatment were measured by immunoassay. Thirty-six percent of patients reported significant psychiatric symptoms on at least one scale. GM-CSF-treated patients reported more severe posttraumatic stress and depression symptoms than patients in the placebo group. In multiple regression analyses, younger age, female sex, higher severity of illness, fewer steroid treatment days, and GM-CSF treatment were all independently associated with more severe psychiatric symptoms on at least one scale.

CONCLUSIONS: 6 months after ARDS, age, sex, illness severity, steroids, and GM-CSF treatment were associated with psychiatric symptom scores. These associations should be confirmed in a larger population. Clinical Trial registered with (NCT00201409).

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