Recruiting

Observational Study

Sponsor:

Kent State University

Code:

NCT04316767

Conditions

Post Intensive Care Unit Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

App Intervention

Study Details

Brief summary:

Family members of critically ill (ICU) patients are at risk for developing significant symptoms of anxiety, depression, and post-traumatic stress during and after the ICU experience. Cognitive behavioral therapy is a form of therapy that can help individuals cope with stressful events in a more active and effective way. This study will examine the effectiveness of a smartphone self-care app delivering cognitive behavioral therapy in decreasing the psychological symptoms suffered by ICU family members. Half of the sample will receive the self-care app and half of the study sample will receive the usual supportive care given to family members of ICU patients. The researchers anticipate the self-care app will diminish the severity of anxiety, depression, and post-traumatic stress symptoms experienced by ICU family members.

Conditions

Post Intensive Care Unit Syndrome

Study ID

NCT04316767

Start date

Aug 28, 2020

Status verified date

Aug, 2020

Completion date

Jan, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or older
  • self-identifies as the family decision-maker of the critically ill patient
  • reads and speaks English
  • owns a smartphone with iOS or Android operating system
  • critically ill family member has been in the ICU greater than three days
  • critically ill family member is mechanically ventilated and lacks cognitive capacity
  • critically ill family member is not expected to be transferred out of the ICU within the next 48 hours
  • critically ill family member is 18 years of age or older.

Exclusion Criteria:

  • Employee of Summa Health System

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: App Intervention

Participants will download a mobile self-care app on their smartphones. The app guides users through exercises based on cognitive behavioral therapy principles. Participants will be able to use the app as frequently as desired throughout the course of the study.

no intervention: Control

Participants will receive usual supportive care provided to family members of ICU patients.

Interventions

App Intervention

Participants will receive access to a self-care app for use on their smartphone. The app provides a suite of tools based on cognitive behavioral therapy and mindfulness. The app guides users through a variety of short lessons (3-5 minutes) that teach users to self-manage stress, mood, anxiety, and depression. Participants will be encouraged to use the app on a daily basis and will be able to use the app at their discretion.

Primary outcome measure

  • Change in anxiety-Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 30 days, 60 days ]
  • Change in depression-Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline, 30 days, 60 days ]
  • Change in post-traumatic stress measured by the PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Baseline, 30 days, 60 days ]
  • Change in health-related quality of life measured by Medical Outcomes Study 12-item Short-Form General Health Survey (SF- 12) [ Time Frame: Baseline, 60 days ]
  • Change in Mental Health Self-Efficacy Scale (MHSES) score [ Time Frame: Baseline, 30 days, 60 days ]

Central Contacts and Locations

Central contacts

Amy B Petrinec, PhD

330-715-2987apetrine@kent.edu

Richard George, MD

330-375-3000georger@summahealth.org

Locations

Summa Health System

Recruiting

Akron, Ohio, United States, 44304

Contacts

Amy B Petrinec, PhD

330-715-2987apetrine@kent.edu

Richard George, MD

330-375-3000georger@summahealth.org

More Information

Sponsor

Kent State University

Last update posted

Sep 2, 2020

Last verified

Aug, 2020

Keywords

  • PICS-F
  • mobile health app
  • health-related quality of life
  • mental health self-efficacy
  • cognitive behavioral therapy
  • ICU family

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kent State University on 2020-09-02.