PTSDNCT04305353
Intensive Care Unit (ICU) Diary Project
A study testing Diary (blank journal) plus PTSD psycho-education and PTSD psycho-education alone in people with PTSD and Post ICU Syndrome, run by Tulane University School of Medicine at 1 site in United States.
Trial summary
Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PTSD, Post ICU Syndrome
- What is being tested?
- Diary (blank journal) plus PTSD psycho-education and PTSD psycho-education alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 1 Sep 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted to the intensive care unit for at least 72 hours
- sedated and mechanically ventilated for at least 24 hours.
- available over-the-phone, up to 6 months post-ICU discharge
Who cannot join
- any patients who do not voluntarily agree to participate
- not fluent in the English language
- patients who have stayed in the ICU for less than 72 hours
- patients who have been sedated and mechanically ventilated for less than 24 hours
- patients with pre-existing severe psychotic illness, bipolar disorder, substance use disorder, PTSD, stroke, traumatic brain injury, neurocognitive impairment, or intellectual disability
- patients with no phone number or reliable contact information for the sake of follow-up
- prisoners
- pregnant patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University School of Medicine
New Orleans, Louisiana, 70112
About this study
Official title: Implementing an Intensive Care Unit (ICU) Diary Program at a Large Academic Medical Center: Results From a Randomized Control Trial Evaluating Psychological Morbidity Associated With Critical Illness
Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress disorder), depression and anxiety.
Read the detailed description
The investigators compared the efficacy of the ICU diary, prospectively written by third-parties during the patient's intensive care course, versus education-alone, on reducing acute PTSD symptoms after discharge. Patients with an ICU stay greater than 72 hours, and who were intubated and mechanically ventilated over 24 hours, were recruited and randomized to either receive a diary at bedside with psychoeducation, or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychometric testing with IES-R, PHQ-8, HADS and GAD-7 was conducted at weeks 4, 12, and 24 after ICU discharge.
- Conditions
- PTSD, Post ICU Syndrome
- Being tested
- Diary (blank journal) plus PTSD psycho-education, PTSD psycho-education alone
- Keywords
- psychocognitive morbidity, narrative medicine, ICU-related PTSD, Post-ICU Syndrome (PICS), ICU Diary
- Medical subject headings
- Stress Disorders, Post-Traumatic, Narrative Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diary (blank journal) plus PTSD psycho-educationOther
A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers
PTSD psycho-education aloneOther
We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources.
References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015.
| Study group | Role | What they receive |
|---|---|---|
| ICU Diary Group | Experimental | Patients randomized to this group receive the ICU diary, along with PTSD education Receives: Other: Diary (blank journal) plus PTSD psycho-education; Other: PTSD psycho-education alone |
| PTSD Education-only Group | Other | Control Group: patients randomized to this group only receive PTSD education Receives: Other: PTSD psycho-education alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms
Revised Impact of Event Scales (IES-R) score, measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. Scores from 1-22 are consistent with mild PTSD, and scores greater than 22 signal clinically significant PTSD symptoms.
Measured: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Secondary outcomes (3)
Change in Hospital-associated Depression and Anxiety symptoms
Hospital Anxiety and Depression Scale (HADS), range of 0-21 for either anxiety or depression subscores, with higher scores corresponding to worse outcomes. Scores of 0-7 are normal, 8-10 are borderline abnormal (mild depression or anxiety), and 11-21 correspond to severe symptoms of anxiety or depression.
Measured: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Change in Depression symptoms
Patient Health Questionnaire (PHQ-8), score ranges 0-24, as higher scores correspond to worse depression symptoms. Scores of 5-10 represent mild symptoms of depression, 10-15 signal moderate symptoms, and 15-24 correspond to severe symptoms.
Measured: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Change in Anxiety symptoms
Generalized Anxiety Disorder 7-item scores (GAD-7) range from 0 to 21, with higher scores corresponding to worse anxiety symptoms. Scores of 0-4 indicate minimal anxiety, 5-9 correspond to mild anxiety, 10-14 signal moderate anxiety, and 15-21 represent severe anxiety.
Measured: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start26 Sep 2017
- Primary completion25 Sep 2018
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Arnold P. Gold Foundation
- Responsible party
- Sponsor
- Investigators
- Rachel Hammer, MD, MFA, Principal investigator, Tulane University School of MedicineGeorge Sayde, MD, MPH, Principal investigator, Tulane University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305353
- Sponsor's protocol ID
- ICU Diary RCT NOLA
- Other IDs
- GH-17-022
- Status last verified
- Apr 2021
- First submitted
- 13 Feb 2020
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May;43(5):1121-9. doi: 10.1097/CCM.0000000000000882.
PubMed 25654178Wintermann GB, Brunkhorst FM, Petrowski K, Strauss B, Oehmichen F, Pohl M, Rosendahl J. Stress disorders following prolonged critical illness in survivors of severe sepsis. Crit Care Med. 2015 Jun;43(6):1213-22. doi: 10.1097/CCM.0000000000000936.
PubMed 25760659Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
PubMed 20843344Myhren H, Ekeberg O, Toien K, Karlsson S, Stokland O. Posttraumatic stress, anxiety and depression symptoms in patients during the first year post intensive care unit discharge. Crit Care. 2010;14(1):R14. doi: 10.1186/cc8870. Epub 2010 Feb 8.
PubMed 20144193Jensen JF, Thomsen T, Overgaard D, Bestle MH, Christensen D, Egerod I. Erratum to: Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. Intensive Care Med. 2015 Jul;41(7):1391. doi: 10.1007/s00134-015-3932-9. No abstract available.
PubMed 26104120Davydow DS, Kohen R, Hough CL, Tracy JH, Zatzick D, Katon WJ. A pilot investigation of the association of genetic polymorphisms regulating corticotrophin-releasing hormone with posttraumatic stress and depressive symptoms in medical-surgical intensive care unit survivors. J Crit Care. 2014 Feb;29(1):101-6. doi: 10.1016/j.jcrc.2013.08.016. Epub 2013 Sep 24.
PubMed 24075295Jones C, Backman C, Griffiths RD. Intensive care diaries and relatives' symptoms of posttraumatic stress disorder after critical illness: a pilot study. Am J Crit Care. 2012 May;21(3):172-6. doi: 10.4037/ajcc2012569.
PubMed 22549573Knowles RE, Tarrier N. Evaluation of the effect of prospective patient diaries on emotional well-being in intensive care unit survivors: a randomized controlled trial. Crit Care Med. 2009 Jan;37(1):184-91. doi: 10.1097/CCM.0b013e31819287f7.
PubMed 19050634Jones C, Griffiths RD, Humphris G, Skirrow PM. Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care. Crit Care Med. 2001 Mar;29(3):573-80. doi: 10.1097/00003246-200103000-00019.
PubMed 11373423Karnatovskaia LV, Johnson MM, Benzo RP, Gajic O. The spectrum of psychocognitive morbidity in the critically ill: a review of the literature and call for improvement. J Crit Care. 2015 Feb;30(1):130-7. doi: 10.1016/j.jcrc.2014.09.024. Epub 2014 Oct 2.
PubMed 25449881Bergbom I, Svensson C, Berggren E, Kamsula M. Patients' and relatives' opinions and feelings about diaries kept by nurses in an intensive care unit: pilot study. Intensive Crit Care Nurs. 1999 Aug;15(4):185-91. doi: 10.1016/s0964-3397(99)80069-x.
PubMed 10786503Ullman AJ, Aitken LM, Rattray J, Kenardy J, Le Brocque R, MacGillivray S, Hull AM. Diaries for recovery from critical illness. Cochrane Database Syst Rev. 2014 Dec 9;2014(12):CD010468. doi: 10.1002/14651858.CD010468.pub2.
PubMed 25488158Garrouste-Orgeas M, Flahault C, Vinatier I, Rigaud JP, Thieulot-Rolin N, Mercier E, Rouget A, Grand H, Lesieur O, Tamion F, Hamidfar R, Renault A, Parmentier-Decrucq E, Monseau Y, Argaud L, Bretonniere C, Lautrette A, Badie J, Boulet E, Floccard B, Forceville X, Kipnis E, Soufir L, Valade S, Bige N, Gaffinel A, Hamzaoui O, Simon G, Thirion M, Bouadma L, Large A, Mira JP, Amdjar-Badidi N, Jourdain M, Jost PH, Maxime V, Santoli F, Ruckly S, Vioulac C, Leborgne MA, Bellalou L, Fasse L, Misset B, Bailly S, Timsit JF. Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):229-239. doi: 10.1001/jama.2019.9058.
PubMed 31310299Sayde GE, Stefanescu A, Conrad E, Nielsen N, Hammer R. Implementing an intensive care unit (ICU) diary program at a large academic medical center: Results from a randomized control trial evaluating psychological morbidity associated with critical illness. Gen Hosp Psychiatry. 2020 Sep-Oct;66:96-102. doi: 10.1016/j.genhosppsych.2020.06.017. Epub 2020 Jul 2.
PubMed 32763640
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Intensive Care Unit (ICU) Diary Program at a Large Academic Medical Center: Results From a Randomized Control Trial Evaluating Psychological Morbidity Associated With Critical Illness
- ClinicalTrials.gov ID
- NCT04305353
- Acronym / sponsor ID
- ICU Diary RCT NOLA
- Conditions
- PTSD, Post ICU Syndrome
- Keywords
- psychocognitive morbidity, narrative medicine, ICU-related PTSD, Post-ICU Syndrome (PICS), ICU Diary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tulane University School of MedicineUniversity, hospital or other
- Collaborators
- The Arnold P. Gold Foundation
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 25 Sep 2018 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 12 Mar 2020 (actual)
- 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.
Psychological morbidity in both patients and family members related to the intensive care unit (ICU) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the Society of Critical Care Medicine as Post-intensive Care Syndrome (PICS). ICU diaries are an intervention increasingly under study with potential to mitigate ICU-related psychological morbidity, include ICU-related PTSD (post-traumatic stress disorder), depression and anxiety.
Detailed description
The investigators compared the efficacy of the ICU diary, prospectively written by third-parties during the patient's intensive care course, versus education-alone, on reducing acute PTSD symptoms after discharge. Patients with an ICU stay greater than 72 hours, and who were intubated and mechanically ventilated over 24 hours, were recruited and randomized to either receive a diary at bedside with psychoeducation, or psychoeducation alone. Intervention patients received their ICU diary within the first week of admission into the intensive care unit. Psychometric testing with IES-R, PHQ-8, HADS and GAD-7 was conducted at weeks 4, 12, and 24 after ICU discharge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU Diary Group | Experimental | Other: Diary (blank journal) plus PTSD psycho-education, Other: PTSD psycho-education alonePatients randomized to this group receive the ICU diary, along with PTSD education |
| PTSD Education-only Group | Other | Other: PTSD psycho-education aloneControl Group: patients randomized to this group only receive PTSD education |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admitted to the intensive care unit for at least 72 hours
- sedated and mechanically ventilated for at least 24 hours.
- available over-the-phone, up to 6 months post-ICU discharge
Key exclusion criteria (8 listed)
- any patients who do not voluntarily agree to participate
- not fluent in the English language
- patients who have stayed in the ICU for less than 72 hours
- patients who have been sedated and mechanically ventilated for less than 24 hours
- patients with pre-existing severe psychotic illness, bipolar disorder, substance use disorder, PTSD, stroke, traumatic brain injury, neurocognitive impairment, or intellectual disability
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 |
|---|---|---|
| Diary (blank journal) plus PTSD psycho-educationA blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers | Other | ICU Diary Group |
| PTSD psycho-education aloneWe administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources. References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015. | Other | ICU Diary Group, PTSD Education-only Group |
Primary outcome
Change in PTSD symptoms
Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Revised Impact of Event Scales (IES-R) score, measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. Scores from 1-22 are consistent with mild PTSD, and scores greater than 22 signal clinically significant PTSD symptoms.
3 secondary outcomes
Change in Hospital-associated Depression and Anxiety symptoms
Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Change in Depression symptoms
Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Change in Anxiety symptoms
Time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Background: PubMed 25654178Parker AM, Sricharoenchai T, Raparla S, Schneck KW, Bienvenu OJ, Needham DM. Posttraumatic stress disorder in critical illness survivors: a metaanalysis. Crit Care Med. 2015 May;43(5):1121-9. doi: 10.1097/CCM.0000000000000882.
- Background: PubMed 25760659Wintermann GB, Brunkhorst FM, Petrowski K, Strauss B, Oehmichen F, Pohl M, Rosendahl J. Stress disorders following prolonged critical illness in survivors of severe sepsis. Crit Care Med. 2015 Jun;43(6):1213-22. doi: 10.1097/CCM.0000000000000936.
- Background: PubMed 20843344Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
- Background: PubMed 20144193Myhren H, Ekeberg O, Toien K, Karlsson S, Stokland O. Posttraumatic stress, anxiety and depression symptoms in patients during the first year post intensive care unit discharge. Crit Care. 2010;14(1):R14. doi: 10.1186/cc8870. Epub 2010 Feb 8.
- Background: PubMed 26104120Jensen JF, Thomsen T, Overgaard D, Bestle MH, Christensen D, Egerod I. Erratum to: Impact of follow-up consultations for ICU survivors on post-ICU syndrome: a systematic review and meta-analysis. Intensive Care Med. 2015 Jul;41(7):1391. doi: 10.1007/s00134-015-3932-9. No abstract available.
- Background: PubMed 24075295Davydow DS, Kohen R, Hough CL, Tracy JH, Zatzick D, Katon WJ. A pilot investigation of the association of genetic polymorphisms regulating corticotrophin-releasing hormone with posttraumatic stress and depressive symptoms in medical-surgical intensive care unit survivors. J Crit Care. 2014 Feb;29(1):101-6. doi: 10.1016/j.jcrc.2013.08.016. Epub 2013 Sep 24.
- Background: PubMed 22549573Jones C, Backman C, Griffiths RD. Intensive care diaries and relatives' symptoms of posttraumatic stress disorder after critical illness: a pilot study. Am J Crit Care. 2012 May;21(3):172-6. doi: 10.4037/ajcc2012569.
- Background: PubMed 19050634Knowles RE, Tarrier N. Evaluation of the effect of prospective patient diaries on emotional well-being in intensive care unit survivors: a randomized controlled trial. Crit Care Med. 2009 Jan;37(1):184-91. doi: 10.1097/CCM.0b013e31819287f7.
- Background: PubMed 11373423Jones C, Griffiths RD, Humphris G, Skirrow PM. Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care. Crit Care Med. 2001 Mar;29(3):573-80. doi: 10.1097/00003246-200103000-00019.
- Background: PubMed 25449881Karnatovskaia LV, Johnson MM, Benzo RP, Gajic O. The spectrum of psychocognitive morbidity in the critically ill: a review of the literature and call for improvement. J Crit Care. 2015 Feb;30(1):130-7. doi: 10.1016/j.jcrc.2014.09.024. Epub 2014 Oct 2.
- Background: PubMed 10786503Bergbom I, Svensson C, Berggren E, Kamsula M. Patients' and relatives' opinions and feelings about diaries kept by nurses in an intensive care unit: pilot study. Intensive Crit Care Nurs. 1999 Aug;15(4):185-91. doi: 10.1016/s0964-3397(99)80069-x.
- Background: PubMed 25488158Ullman AJ, Aitken LM, Rattray J, Kenardy J, Le Brocque R, MacGillivray S, Hull AM. Diaries for recovery from critical illness. Cochrane Database Syst Rev. 2014 Dec 9;2014(12):CD010468. doi: 10.1002/14651858.CD010468.pub2.
- 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.
Rachel Hammer, MD, MFA principal investigator
Tulane University School of Medicine
George Sayde, MD, MPH principal investigator
Tulane University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diary (blank journal) plus PTSD psycho-education and PTSD psycho-education alone in people with PTSD and Post ICU Syndrome, run by Tulane University School of Medicine 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 3 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: finished, as of the sponsor's last update on 13 Apr 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD symptoms (time frame: at baseline (within one week of ICU admission) versus twelve-weeks post-ICU discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305353, which also lists 14 linked publications.
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 13 Apr 2021.