Optimizing a self-directed mobile mindfulness intervention for improving cardiorespiratory failure survivors' psychological distress (LIFT2): Design and rationale of a randomized factorial experimental clinical trial

Abstract

Introduction Although as many as 75% of the >2 million annual intensive care unit (ICU) survivors experience symptoms of psychological distress that persist for months to years, few therapies exist that target their symptoms and accommodate their unique needs. In response, we developed LIFT, a mobile app-based mindfulness intervention. LIFT reduced distress symptoms more than either a telephone-based mindfulness program or education control in a pilot randomized clinical trial (LIFT1). Objective To describe the methods of a factorial experimental clinical trial (LIFT2) being conducted to aid in the development and implementation of the version of the LIFT intervention that is optimized across domains of effect, feasibility, scalability, and costs. Methods and analysis The LIFT2 study is an optimization trial conceptualized as a component of a larger multiphase optimization strategy (MOST) project. The goal of LIFT2 is to use a 2 × 2 × 2 factorial experimental trial involving 152 patients to determine the ideal components of the LIFT mobile mindfulness program for ICU survivors across factors including (1) study introduction by call from a therapist vs. app only, (2) response to persistent or worsening symptoms over time by therapist vs. app only, and (3) high dose vs. low dose. The primary trial outcome is change in depression symptoms 1 month from randomization measured by the PHQ-9 instrument. Secondary outcomes include anxiety, post-traumatic stress disorder, and physical symptoms; measures of feasibility, acceptability, and usability; as well as themes assessed through qualitative analysis of semi-structured interviews with study participants conducted after follow up completion. We will use general linear models to compare outcomes across the main effects and interactions of the factors.

Effects of MBSR therapy on negative emotions, fatigue, and sleep quality in “post-ICU patients”

“…With the continuous progress of diagnosis and treatment technology, the survival rate of ICU patients is gradually improving, and the probability of patients being transferred out of ICU is also increasing. [ 4 ] Patients who are transferred from the ICU to the general ward receive either primary care or advanced care; however, there are differences between ICU and general ward in terms of equipment, specialized experience of medical staff and care ability of family members, at the same time, patients and their families need to readjust to the environment. On the basis of the above reasons, the continuous care of patients will be affected to some extent and the nursing risk will increase.…”

“…[26] MBSR has achieved significant efficacy in the regulation of physical and mental health in a variety of diseases. [18][19][20] MBSR is currently used primarily for discharged ICU survivors and is administered via multiple mobile programs or telephone, [4,7,16] whereas standard MBSR, which typically provides face-to-face training in a group setting, [28] is controversial for patients moving from ICU to general ward. Therefore, we intended to investigate the effects of MBSR on negative emotions, fatigue, and sleep quality in hospitalized patients transferred from ICU to general ward in a prospective randomized controlled trial.…”

“…[ 21 , 22 ] However, for ICU survivors, this therapy is only applied to discharged patients at present. [ 4 , 7 ] Although the feasibility and acceptability of this therapy for ICU survivors and positive effects on patients’ psychological distress and physical symptoms have been confirmed, the family environment is completely different from the general ward environment. There is currently a lack of standard clinical studies to evaluate the effect of MBSR on inpatients transferred from ICU to general wards.…”

“…[3] Of the more than 2 million ICU survivors each year, up to 75% will experience months or even years of psychological distress. [4] A number of studies have indicated that ICU survivors will develop multiple negative emotions, including anxiety, depression, posttraumatic syndrome, and other emotions, and such negative symptoms will last for more than 1 year. [5][6][7] At present, clinical worker pay more attention to the safety of transition from ICU to general ward, [8,9] the professionalism and continuity of nursing, [10][11][12] and the care of family members, [13] while ignoring the patients' own physical and mental state regulation.…”

“…Currently, MBSR has been widely used in post-traumatic stress disorder, [18] cancer, [19,20] and other diseases, and the results show that MBSR has a positive effect on improving negative emotions and sleep disorders [21,22] . However, for ICU survivors, this therapy is only applied to discharged patients at present [4,7] . Although the feasibility and acceptability of this therapy for ICU survivors and positive effects on patients’ psychological distress and physical symptoms have been confirmed, the family environment is completely different from the general ward environment.…”