Prevention of Post Intensive Care Syndrome-Family with Sensation Awareness Focused Training Intervention: A Randomized Controlled Trial Pilot Study

Post Intensive Care Syndrome-Family (PICS-F) refers to acute and chronic psychological effects of critical illness on family members of patients in intensive care units (ICU). Evidence about the increase and persistence of PICS-F warrants the need for prevention interventions. This study evaluated the feasibility of providing Sensation Awareness Focused Training (SĀF-T) during the ICU stay for spouses of mechanically ventilated patients. Methods: A randomized controlled trial of SĀF-T versus a control group was conducted (n=10) to assess safety, acceptability, feasibility, and effect size of the intervention on PICS-F symptoms. Symptoms assessed as outcome measures included stress, anxiety, depression, posttraumatic stress disorder, and sleep efficiency. Those randomly assigned to SĀF-T received one session daily over 3-days in the ICU. Repeated measures (day 1, day 3, day 30, and day 90) of PICS-F symptoms in both groups were analyzed. Results: Mean age was 58 ± 12 years; 70% were female. Feasibility success criteria were met in weekly recruitment (8 ± 3.5), enrollment rate (67%), SĀF-T acceptability (100% of doses received, no adverse events) with significantly lower post SĀF-T stress levels (p\u3c.05) compared to pre SĀF-T stress levels, ActiWatch acceptability rate (90% agreed to wear, no adverse events) with no significant difference in sleep efficiency between groups (p\u3e.05), and repeated measures completion rate (\u3e90%). Conclusions: This study provided guidance for modifications to protocol outcome measures and evidence of a large effect size, which will inform a larger clinical trial to assess the effectiveness of the SĀF-T intervention in reducing PICS-F