NCT04316767

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

August 28, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

March 17, 2020

Last Update Submit

August 31, 2020

Conditions

Post Intensive Care Unit Syndrome

Keywords

PICS-Fmobile health apphealth-related quality of lifemental health self-efficacycognitive behavioral therapyICU family

Outcome Measures

Primary Outcomes (5)

  • Change in anxiety-Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item self-report scale with seven items forming an anxiety subscale (HADS-A) and seven items forming a depression subscale (HADS-D). Each of the two subscales can have scores ranging from 0-21 with higher scores indicating higher levels of anxiety or depression symptoms.

    Baseline, 30 days, 60 days

  • Change in depression-Hospital Anxiety and Depression Scale (HADS)

    The HADS is a 14-item scale with seven items forming an anxiety subscale (HADS-A) and seven items forming a depression subscale (HADS-D). Each of the two subscales can have scores ranging from 0-21 with higher scores indicating higher levels of anxiety or depression symptoms.

    Baseline, 30 days, 60 days

  • Change in post-traumatic stress measured by the PTSD Checklist for DSM-5 (PCL-5)

    The PCL-5 is a 20-item self-report measure corresponding to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for PTSD. A total symptom severity score (0-80) can be obtained by summing all of the items with higher scores indicating higher severity of PTSD symptoms.

    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)

    The SF-12 is a 12-item self-report scale measuring health-related quality of life. Each item on the scale is scored using a Likert-type scale with raw scores transformed to a 0 (worst) to 100 (best) scale. The scale provides a summary score of 0 to 100 for physical and mental quality of life with higher scores representing a more positive quality of life.

    Baseline, 60 days

  • Change in Mental Health Self-Efficacy Scale (MHSES) score

    The MHSES is a 6-item scale measuring mental health self-efficacy. Each item is measured on a 10-point Likert scale ranging from 1 (not at all confident) to 10 (totally confident). Items are summed for a total score ranging from 6-60 with higher scores indicating higher levels of mental health self-efficacy.

    Baseline, 30 days, 60 days

Secondary Outcomes (1)

  • App usage

    From enrollment to study completion (60 days)

Study Arms (2)

App Intervention

EXPERIMENTAL

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.

Behavioral: App Intervention

Control

NO INTERVENTION

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

Interventions

App InterventionBEHAVIORAL

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.

Also known as: Sanvello app
App Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Employee of Summa Health System

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Summa Health System

Akron, Ohio, 44304, United States

RECRUITING

Related Publications (1)

  • Petrinec AB, Hughes JW, Zullo MD, Wilk C, George RL. Smartphone Delivery of Cognitive Behavioral Therapy for Postintensive Care Syndrome-Family: Protocol for a Pilot Study. JMIR Res Protoc. 2021 Aug 4;10(8):e30813. doi: 10.2196/30813.

    PMID: 34346900DERIVED

Study Officials

  • Amy B Petrinec, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy B Petrinec, PhD

CONTACT

330-715-2987apetrine@kent.edu

Richard George, MD

CONTACT

330-375-3000georger@summahealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, repeated measures, longitudinal design with randomization to one of two parallel groups (control, intervention) will be employed. Participants will be randomized to group assignment after study enrollment is completed and baseline measurements are obtained.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 20, 2020

Study Start

August 28, 2020

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available.

Locations

US(1)