Post-Traumatic Growth, PsychologicalNCT02940028
ICU Experience in Family Members
A study testing Expressive writing in people with Post-Traumatic Growth, Psychological, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Growth, Psychological
- What is being tested?
- Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2017to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Mardee Merrill, 801-507-4608, Mardee.Merill@imail.org
Valerie Aston, (801) 507-4606, valerie.aston@imail.org
About this study
Official title: ICU Experience Among Family Members of ICU Patients
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).
- Conditions
- Post-Traumatic Growth, Psychological
- Being tested
- Expressive writing, Control writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
Brief expressive writing intervention
Control writingBehavioural
Brief fact-based writing exercise.
| Study group | Role | What they receive |
|---|---|---|
| Expressive writing intervention | Experimental | The intervention group will participate in a brief expressive writing intervention. Receives: Behavioral: Expressive writing |
| Control writing intervention | Other | The control group will receive a control writing condition (fact based writing). Receives: Behavioral: Control writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic Growth Inventory
Measured: 4 months
Secondary outcomes (8)
Hospital Depression and Anxiety Scale
Measured: 4 months
Impact of Event Scale Revised (IES-R)
Measured: 4 months
Perceived Stress Scale
Measured: 4 months
Brief COPE
Measured: 4 months
Physical Symptoms Scale
Measured: 4 months
Groningen Activity Restriction Scale (GARS)
Measured: 4 months
Activity Restriction Scale
Measured: 4 months
Essay Evaluation Measure
The 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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start29 Apr 2017
- Primary completionDec 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Growth, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramona Hopkins, PhD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940028
- Sponsor's protocol ID
- 1050308
- Status last verified
- Jun 2020
- First submitted
- 12 Oct 2016
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Experience Among Family Members of ICU Patients
- ClinicalTrials.gov ID
- NCT02940028
- Acronym / sponsor ID
- 1050308
- Conditions
- Post-Traumatic Growth, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- 29 Apr 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Expressive writing intervention | Experimental | Behavioral: Expressive writingThe intervention group will participate in a brief expressive writing intervention. |
| Control writing intervention | Other | Behavioral: Control writingThe control group will receive a control writing condition (fact based writing). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingBrief expressive writing intervention | Behavioural | Expressive writing intervention |
| Control writingBrief fact-based writing exercise. | Behavioural | Control writing intervention |
Primary outcome
Posttraumatic Growth Inventory
Time frame: 4 months
8 secondary outcomes
Hospital Depression and Anxiety Scale
Time frame: 4 months
Impact of Event Scale Revised (IES-R)
Time frame: 4 months
Perceived Stress Scale
Time frame: 4 months
Brief COPE
Time frame: 4 months
Physical Symptoms Scale
Time frame: 4 months
Groningen Activity Restriction Scale (GARS)
Time frame: 4 months
Activity Restriction Scale
Time frame: 4 months
Essay Evaluation Measure
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramona Hopkins, PhD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing in people with Post-Traumatic Growth, Psychological, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mardee Merrill (801-507-4608, mardee.merrill@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Posttraumatic Growth Inventory (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.