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.
Anxiety
Critical illness
Depression
Factorial experimental trial
Intensive care units
MOST
Mindfulness
Multiphase optimization strategy
Optimization
Post-traumatic stress disorder
Psychological distress
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
09 2020
09 2020
Historique:
received:
03
04
2020
revised:
05
08
2020
accepted:
11
08
2020
pubmed:
18
8
2020
medline:
25
9
2021
entrez:
18
8
2020
Statut:
ppublish
Résumé
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). 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. 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.
Identifiants
pubmed: 32805434
pii: S1551-7144(20)30197-X
doi: 10.1016/j.cct.2020.106119
pmc: PMC7428440
pii:
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106119Subventions
Organisme : NCCIH NIH HHS
ID : R01 AT009974
Pays : United States
Organisme : NCCIH NIH HHS
ID : U01 AT009974
Pays : United States
Organisme : NCCIH NIH HHS
ID : R34 AT008819
Pays : United States
Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.
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