Skip to content

ICU Experience in Family Members

ICU Experience Among Family Members of ICU Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02940028
Enrollment
130
Registered
2016-10-20
Start date
2017-04-29
Completion date
2021-04-30
Last updated
2020-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Growth, Psychological

Brief summary

The ICU is a stressful and challenging place for patients and their families. Many family members experience anxiety, depression, and post-traumatic stress disorder during and after their ICU experience. The investigators are studying post-traumatic growth in this study. Post-traumatic growth (PTG) is a set of positive changes that occurs after a challenging or difficult life experience. This study investigates the effects of expressive writing on positive changes that occur after a difficult experience. PTG will be compared between the intervention group receiving the expressive writing intervention and the control group (non-expressive or fact based writing).

Interventions

BEHAVIORALExpressive writing

Brief expressive writing intervention

BEHAVIORALControl writing

Brief fact-based writing exercise.

Sponsors

Intermountain Health Care, Inc.
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Family members of ICU patients are eligible for the study. We will enroll one study participant per patient admitted to a study ICU (Shock Trauma or Respiratory ICU at Intermountain Medical Center) who meets the following inclusion criteria: * Participant can be a family member of a patient admitted to a study ICU for \>24 hours and ≥1 of the following: * mechanical ventilation via endotracheal tube for ≥ 12 hours * non-invasive ventilation (CPAP, BiPAP) for \> 4 hours in a 24-hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use) * high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours * use of vasopressors for shock of any etiology for \>1 hour * Both participant and ICU patient must be adult (age ≥18 years of age) * Participant must be able to read, speak, and write in English * Participant must be enrolled within 72 hours of the patient's meeting mechanical ventilation criteria Participants who live with the patient will be accorded higher priority than those who do not live with the patient because they are more likely to be involved as caregivers. The preference would be for the participant to be the designated power of attorney; if there is no designated power of attorney living with the patient, then the primary informal caregiver (identified either by the patient or by the family) would be enrolled; if either of these is not available, the default surrogate (defined in figure 1) would be enrolled. If no one living with the patient meets these criteria, then family members and informal caregivers not living with the patient will be screened for the study. The preference would again be for first, the designated power of attorney, then a primary caregiver and a default surrogate. An informal caregiver provides care without reimbursement.

Exclusion criteria

* Pregnant or breastfeeding females * Prisoners * Children (age \<18 years of age) * Known history of PTSD, dementia, or schizophrenia. Presence of these illnesses will be per participant report of physician diagnosis and treatment * If a patient has been transferred from another ICU after an ICU course greater than 24 hours, or if the patient has had a previous ICU or long term acute care (LTAC) admission in the last 90 days, the family member or caregiver will be excluded. * Patients admitted for hospice * Participants who live more than 200 miles away or who have no specified domicile * Non-English speaking

Design outcomes

Primary

MeasureTime frame
Posttraumatic Growth Inventory4 months

Secondary

MeasureTime frameDescription
Impact of Event Scale Revised (IES-R)4 months
Perceived Stress Scale4 months
Brief COPE4 months
Hospital Depression and Anxiety Scale4 months
Groningen Activity Restriction Scale (GARS)4 months
Activity Restriction Scale4 months
Essay Evaluation Measure4 monthsThe essay evaluation measure assesses if the writing sample (essay) was personal, meaningful and reveals emotions. This measure has 3 items that are scored 0 to 6 for a total score of 0 to 18.
Physical Symptoms Scale4 months

Countries

United States

Contacts

Primary ContactMardee Merrill
mardee.merrill@imail.org801-507-4608
Backup ContactRamona Hopkins, PhD
mona.hopkins@imail.org(801) 507-4569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026