Cargando…
A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE
BACKGROUND: People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. OBJECTIVE: The aim of this study is to conduct a fully remote randomized...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8663659/ https://www.ncbi.nlm.nih.gov/pubmed/34766913 http://dx.doi.org/10.2196/29201 |
_version_ | 1784613689796591616 |
---|---|
author | Ben-Zeev, Dror Chander, Ayesha Tauscher, Justin Buck, Benjamin Nepal, Subigya Campbell, Andrew Doron, Guy |
author_facet | Ben-Zeev, Dror Chander, Ayesha Tauscher, Justin Buck, Benjamin Nepal, Subigya Campbell, Andrew Doron, Guy |
author_sort | Ben-Zeev, Dror |
collection | PubMed |
description | BACKGROUND: People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. OBJECTIVE: The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. METHODS: Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. RESULTS: Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F(1,313)=13.38; P<.001), GAD-7 (F(1,313)=5.87; P=.01), RAS (F(1,313)=23.42; P<.001), RSES (F(1,313)=19.28; P<.001), and SDS (F(1,313)=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. CONCLUSIONS: We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. TRIAL REGISTRATION: ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467 |
format | Online Article Text |
id | pubmed-8663659 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-86636592021-12-30 A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE Ben-Zeev, Dror Chander, Ayesha Tauscher, Justin Buck, Benjamin Nepal, Subigya Campbell, Andrew Doron, Guy J Med Internet Res Original Paper BACKGROUND: People with serious mental illness (SMI) have significant unmet mental health needs. Development and testing of digital interventions that can alleviate the suffering of people with SMI is a public health priority. OBJECTIVE: The aim of this study is to conduct a fully remote randomized waitlist-controlled trial of CORE, a smartphone intervention that comprises daily exercises designed to promote reassessment of dysfunctional beliefs in multiple domains. METHODS: Individuals were recruited via the web using Google and Facebook advertisements. Enrolled participants were randomized into either active intervention or waitlist control groups. Participants completed the Beck Depression Inventory-Second Edition (BDI-II), Generalized Anxiety Disorder-7 (GAD-7), Hamilton Program for Schizophrenia Voices, Green Paranoid Thought Scale, Recovery Assessment Scale (RAS), Rosenberg Self-Esteem Scale (RSES), Friendship Scale, and Sheehan Disability Scale (SDS) at baseline (T1), 30-day (T2), and 60-day (T3) assessment points. Participants in the active group used CORE from T1 to T2, and participants in the waitlist group used CORE from T2 to T3. Both groups completed usability and accessibility measures after they concluded their intervention periods. RESULTS: Overall, 315 individuals from 45 states participated in this study. The sample comprised individuals with self-reported bipolar disorder (111/315, 35.2%), major depressive disorder (136/315, 43.2%), and schizophrenia or schizoaffective disorder (68/315, 21.6%) who displayed moderate to severe symptoms and disability levels at baseline. Participants rated CORE as highly usable and acceptable. Intent-to-treat analyses showed significant treatment×time interactions for the BDI-II (F(1,313)=13.38; P<.001), GAD-7 (F(1,313)=5.87; P=.01), RAS (F(1,313)=23.42; P<.001), RSES (F(1,313)=19.28; P<.001), and SDS (F(1,313)=10.73; P=.001). Large effects were observed for the BDI-II (d=0.58), RAS (d=0.61), and RSES (d=0.64); a moderate effect size was observed for the SDS (d=0.44), and a small effect size was observed for the GAD-7 (d=0.20). Similar changes in outcome measures were later observed in the waitlist control group participants following crossover after they received CORE (T2 to T3). Approximately 41.5% (64/154) of participants in the active group and 60.2% (97/161) of participants in the waitlist group were retained at T2, and 33.1% (51/154) of participants in the active group and 40.3% (65/161) of participants in the waitlist group were retained at T3. CONCLUSIONS: We successfully recruited, screened, randomized, treated, and assessed a geographically dispersed sample of participants with SMI entirely via the web, demonstrating that fully remote clinical trials are feasible in this population; however, study retention remains challenging. CORE showed promise as a usable, acceptable, and effective tool for reducing the severity of psychiatric symptoms and disability while improving recovery and self-esteem. Rapid adoption and real-world dissemination of evidence-based mobile health interventions such as CORE are needed if we are to shorten the science-to-service gap and address the significant unmet mental health needs of people with SMI during the COVID-19 pandemic and beyond. TRIAL REGISTRATION: ClinicalTrials.gov NCT04068467; https://clinicaltrials.gov/ct2/show/NCT04068467 JMIR Publications 2021-11-12 /pmc/articles/PMC8663659/ /pubmed/34766913 http://dx.doi.org/10.2196/29201 Text en ©Dror Ben-Zeev, Ayesha Chander, Justin Tauscher, Benjamin Buck, Subigya Nepal, Andrew Campbell, Guy Doron. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 12.11.2021. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research, is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included. |
spellingShingle | Original Paper Ben-Zeev, Dror Chander, Ayesha Tauscher, Justin Buck, Benjamin Nepal, Subigya Campbell, Andrew Doron, Guy A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE |
title | A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE |
title_full | A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE |
title_fullStr | A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE |
title_full_unstemmed | A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE |
title_short | A Smartphone Intervention for People With Serious Mental Illness: Fully Remote Randomized Controlled Trial of CORE |
title_sort | smartphone intervention for people with serious mental illness: fully remote randomized controlled trial of core |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8663659/ https://www.ncbi.nlm.nih.gov/pubmed/34766913 http://dx.doi.org/10.2196/29201 |
work_keys_str_mv | AT benzeevdror asmartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT chanderayesha asmartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT tauscherjustin asmartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT buckbenjamin asmartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT nepalsubigya asmartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT campbellandrew asmartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT doronguy asmartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT benzeevdror smartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT chanderayesha smartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT tauscherjustin smartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT buckbenjamin smartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT nepalsubigya smartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT campbellandrew smartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore AT doronguy smartphoneinterventionforpeoplewithseriousmentalillnessfullyremoterandomizedcontrolledtrialofcore |