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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.

SUBMITTER: Cox CE

PROVIDER: S-EPMC7428440 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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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.

Cox Christopher E CE Olsen Maren K MK Gallis John A JA Porter Laura S LS Greeson Jeffrey M JM Gremore Tina T Frear Allie A Ungar Anna A McKeehan Jeffrey J McDowell Brittany B McDaniel Hannah H Moss Marc M Hough Catherine L CL

Contemporary clinical trials 20200815

<h4>Introduction</h4>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).<h ...[more]

PMID: 32805434

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Project description:BackgroundThe COVID-19 pandemic has dramatically affected mental health, creating an urgent need for convenient and safe interventions to improve well-being. Online mindfulness interventions show promise for improving depression, anxiety, and general well-being.ObjectiveTo assess: 1) the impact of online mindfulness on psychological distress, 2) altruistic efforts, and 3) the quantity, quality, and availability of online mindfulness resources during the COVID-19 pandemic.Methods233 participants (203 U.S.; 20 international; 10 unknown) participated in this prospective, single-arm, non-randomized clinical trial of a single online mindfulness meditation session with pre- and post-surveys.Main outcome measures(a) Mindfulness session helpfulness, online platform effectiveness, and immediate pre- to post-session changes in momentary stress, anxiety, and COVID-19 concern; (b) qualitative themes representing how people are helping others during the pandemic; (c) absolute changes in quantity of mindfulness-oriented web content and free online mindfulness resource availability from May to August 2020.ResultsMost participants felt the online mindfulness session was helpful and the electronic platform effective for practicing mindfulness (89%, 95% CI: [82 to 93%]), with decreased momentary anxiety (76%; 95% CI: [69 to 83%]), stress (80%; [72 to 86%]), and COVID-19 concern (55%; [46 to 63%]), (p < 0.001 for each measure). Participants reported helping others in a variety of ways during the pandemic, including following public health guidelines, conducting acts of service and connection, and helping oneself in hopes of helping others. "Mindfulness + COVID" search results increased by 52% from May to August 2020. Most (73%) Academic Consortium for Integrative Medicine and Health member websites offer free online mindfulness resources.ConclusionsVirtual mindfulness is an increasingly accessible intervention available world-wide that may reduce psychological distress during this isolating public health crisis. Kindness and altruism are being demonstrated during the pandemic. The consolidated online mindfulness resources provided may help guide clinicians and patients.

Project description:Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy. Additionally, no trials have focused on potential physiological changes that may occur as a result of receiving mindfulness training in pregnancy. The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy.A randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of MBCT to treat psychological distress in pregnancy. A sample of 60 consenting pregnant women aged 18 years and above will be enrolled and randomized to the experimental (MBCT) or control (treatment as usual) condition. Primary (e.g., symptoms of stress, depression, and anxiety), secondary (cortisol, blood pressure (BP), heart rate variability (HRV), and sleep) and other outcome data (e.g., psychological diagnoses) will be collected via a combination of laboratory visits and at-home assessments from both groups at baseline (T1), immediately following the intervention (T2), and at 3 months postpartum (T3). Descriptive statistics will be used to describe sample characteristics. Data will be analyzed using an intention-to-treat approach. Hierarchical linear models will be used to test intervention effects on primary and secondary outcomes.The trial is expected to improve knowledge about evidence-based treatments for psychological distress experienced in pregnancy and to evaluate the potential impact of mindfulness-based interventions on maternal physiology.ClinicalTrials.gov: NCT02214732 , registered on 7 August 2014. Protocol Version 2.0., 5 September 2016.

Dataset Information

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.

Publications

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.

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