Stress Disorders, Post TraumaticNCT02067559
Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries
A study testing ICU Diary and Psychoeducation in people with Stress Disorders, Post Traumatic and Anxiety, run by University of Manitoba at 1 site in Canada.
Trial summary
The main objective of the study is to test the feasibility of the ICU diaries intervention in the ICU. The investigators do not have sufficient power to detect differences in the hypotheses below, but will use the present pilot study to inform sample size required to adequately power a follow-up randomized control… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Stress Disorders, Post Traumatic, Anxiety, Depression
- What is being tested?
- ICU Diary and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Nov 2016
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age greater than 17 years
- enrolment within 72 hours of ICU admission
- time of ICU stay is predicted to be >72 hours by ICU treatment team
- greater than 24 hours mechanical ventilation required
- understand verbal and written English
Who cannot join
- no caregiver/family available
- terminal illness with life expectancy of less than 6 months
- pre-existing cognitive impairment
- less than 24 hours of mechanical ventilation
- reason for ICU admission is suicide attempt / overdose
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the study is to test the feasibility of the ICU diaries intervention in the ICU. The investigators do not have sufficient power to detect differences in the hypotheses below, but will use the present pilot study to inform sample size required to adequately power a follow-up randomized control trial.
(1) The investigators hypothesize that subjects exposed to a psychoeducation condition will have reduced rates of post-traumatic stress disorder (PTSD) compared to those experiencing treatment as usual (TAU). (2) The investigators hypothesize that compared to participants in the psychoeducation and TAU groups, those subjects exposed to an ICU diary, and those exposed to both ICU diary + psychoeducation conditions, will have significantly reduced rates of PTSD at follow-up. (3)The investigators hypothesize that participants exposed to the ICU diary + psychoeducation condition will have significantly lower rates of PTSD compared to those in the ICU diary alone condition.
Read the detailed description
This is a randomized controlled pilot study involving patients who are in the ICU, for a minimum of 72 hrs with > 24 hrs mechanical ventilation. As is common in ICU research, proxy consent will be obtained from family members upon ICU admission. Patients will be randomized to 4 different conditions (1) treatment as usual (TAU) (2) ICU diary (3) psychoeducation (4) ICU diary + psychoeducation. The ICU diary will be created and maintained by nurses and family members for each patient randomized to condition (2) and (4), and will be given to patients by a research nurse upon discharge from the ICU. The patients in conditions (3) and (4) will receive a psychoeducational brochure detailing general treatment and sedation patients receive in the ICU, and the psychological symptoms such as depression and PTSD that can occur after a stay in the ICU. This brochure will also be sent to their follow-up physician. Patients in all conditions will be assessed at one week post-ICU for recollection of delusional memories using ICU Memory Tool (ICUMT), at one- and three-month post-ICU for baseline PTSD symptoms using Impact of Events Scale-Revised (IES-R), a commonly used measure of PTSD symptomatology, as well as measures of anxiety/depression, social support, and general health. At one and three month follow-up, the investigators will also ask patients if they had contact with their health care providers/follow-up physicians, sought mental health treatment, their general impressions of the intervention they received (diary, psychoeducation, both), and whether/how often they reviewed the document (if in conditions 2-4). The investigators will ascertain feasibility from the health care provider and family perspective by appending a short questionnaire to the diary, to be filled out each time an entry is made.
- Conditions
- Stress Disorders, Post Traumatic, Anxiety, Depression, Quality of Life
- Being tested
- ICU Diary, Psychoeducation
- Keywords
- Post Traumatic Stress Disorder, PTSD, Intensive Care Unit, ICU
- Medical subject headings
- Combat Disorders, Anxiety Disorders, Depression, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU DiaryBehavioural
Creation of an ICU diary: A bound empty journal will be stored at the patient's bedside near the nurse charting area. All family members and ICU staff are invited to write in the ICU diary at any time. Procedure for diary writing will follow previous research (see www.icu-diary.org).
PsychoeducationBehavioural
The psychoeducation brochure will describe procedures in the ICU (sedation, ventilation), and the delirium, hallucinations, and trauma that may result; as well as symptoms of PTSD post-ICU. It will provide instructions for follow-up, information, and emergency care. The brochure will instruct participants to contact their follow-up healthcare provider if they have any questions.
| Study group | Role | What they receive |
|---|---|---|
| ICU Diaries | Experimental | A bound empty journal will be stored at the patient's bedside near the nurse charting area. All family members and ICU staff are invited to write in the ICU diary at any time. Instructions will be provided to the patient's family at the time of randomization and will be available at the bedside for reference. Staff instructions will be posted at charting area for staff. During the patient's stay in ICU, the diary will never leave the unit. Under no circumstances will any part of an ICU diary be duplicated. Research staff will take a photograph of the patient after consent is obtained and the photograph will be mounted on the first page of the diary. Photographs will be taken with a Polaroid camera; therefore there will be no other record of the photograph. Receives: Behavioral: ICU Diary |
| Psychoeducation | Experimental | The research nurse will provide a psychoeducational brochure to study participants at ICU discharge (if cognitive capacity is established) or 30 days after ICU discharge. If participants are not well enough 30 days post-discharge, they will be assessed every two weeks by research staff until the brochure is given to them. The brochure will describe procedures in the ICU (sedation, ventilation), and the delirium, hallucinations, and trauma that may result; as well as symptoms of PTSD post-ICU. It will provide instructions for follow-up, information, and emergency care. The brochure will instruct participants to contact their follow-up healthcare provider if they have any questions. The document will also be mailed to the participant's follow-up physician. Receives: Behavioral: Psychoeducation |
| ICU Diary plus Psychoeducation | Experimental | Participants will receive both ICU diary and psychoeducation interventions, with both documents provided at ICU-discharge, or 30 days post-discharge as above. Receives: Behavioral: ICU Diary; Behavioral: Psychoeducation |
| Treatment as Usual | No intervention | No additional intervention to usual ICU care will be given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - enrollment of 1-2 participants per month
To test the feasibility of ICU diaries in a Canadian ICU setting by asking nurses and family members about the process of creating the diary.
Specifically, feasibility of diary will be determined by a survey about the usability, time spent, and general comments on using the diary. Surveys will be filled by each individual making a diary entry (visitors and hospital staff).
Measured: One year
Secondary outcomes (3)
Efficacy at 90 days as determined by Impact of Event Scores (IES-R)
The investigators will measure patients' Impact of Event Scores - Revised (IES-R) at 90 days post-ICU discharge. These scores will be compared across the four intervention groups (ICU Diaries, Psychoeducation, ICU Diary + Psychoeducation, Treatment as Usual).
Measured: 90 days
Change in IES-R 30 days post ICU discharge and access to follow up care at 90 days post ICU discharge
The investigators will measure differences (across treatment groups) between participant's Impact of Event Scores (IES-R) at 30 days post-discharge, and proportion of participants accessing follow-up care (psychiatric, psychological, primary care) at 90 days post-ICU discharge.
The investigators will also assess anxiety, depression, quality of life scores, and social support scores 30 and 90 days post-ICU discharge, and measure the associations between these factors and the ICU Memory Tool (ICUMT) scores.
Measured: 30 and 90 days post ICU Discharge
IES-R score of family member at 30 days post patient ICU discharge
The investigators will assess family members of the discharged patient for IES-R scores at 30 days post-patient discharge.
Measured: 30 days 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 posted20 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post TraumaticStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Responsible party
- Sponsor
- Investigators
- Marcus R Blouw, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067559
- Sponsor's protocol ID
- H2013:460
- Other IDs
- 8-2014-07
- Status last verified
- May 2017
- First submitted
- 18 Feb 2014
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Davydow DS, Gifford JM, Desai SV, Needham DM, Bienvenu OJ. Posttraumatic stress disorder in general intensive care unit survivors: a systematic review. Gen Hosp Psychiatry. 2008 Sep-Oct;30(5):421-34. doi: 10.1016/j.genhosppsych.2008.05.006. Epub 2008 Jul 30.
PubMed 18774425Jones C, Backman C, Capuzzo M, Flaatten H, Rylander C, Griffiths RD. Precipitants of post-traumatic stress disorder following intensive care: a hypothesis generating study of diversity in care. Intensive Care Med. 2007 Jun;33(6):978-85. doi: 10.1007/s00134-007-0600-8. Epub 2007 Mar 24.
PubMed 17384929Backman CG, Walther SM. Use of a personal diary written on the ICU during critical illness. Intensive Care Med. 2001 Feb;27(2):426-9. doi: 10.1007/s001340000692.
PubMed 11396288Jones 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 20843344Jones 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 22549573Cuthbertson BH, Hull A, Strachan M, Scott J. Post-traumatic stress disorder after critical illness requiring general intensive care. Intensive Care Med. 2004 Mar;30(3):450-5. doi: 10.1007/s00134-003-2004-8. Epub 2003 Sep 5.
PubMed 12961065Kredentser MS, Blouw M, Marten N, Sareen J, Bienvenu OJ, Ryu J, Beatie BE, Logsetty S, Graff LA, Eggertson S, Sweatman S, Debroni B, Cianflone N, Arora RC, Zarychanski R, Olafson K. Preventing Posttraumatic Stress in ICU Survivors: A Single-Center Pilot Randomized Controlled Trial of ICU Diaries and Psychoeducation. Crit Care Med. 2018 Dec;46(12):1914-1922. doi: 10.1097/CCM.0000000000003367.
PubMed 30119073
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries
- ClinicalTrials.gov ID
- NCT02067559
- Acronym / sponsor ID
- H2013:460
- Conditions
- Stress Disorders, Post Traumatic, Anxiety, Depression, Quality of Life
- Keywords
- Post Traumatic Stress Disorder, PTSD, Intensive Care Unit, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Study start
- Mar 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 20 Feb 2014 (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 main objective of the study is to test the feasibility of the ICU diaries intervention in the ICU. The investigators do not have sufficient power to detect differences in the hypotheses below, but will use the present pilot study to inform sample size required to adequately power a follow-up randomized control trial.
(1) The investigators hypothesize that subjects exposed to a psychoeducation condition will have reduced rates of post-traumatic stress disorder (PTSD) compared to those experiencing treatment as usual (TAU). (2) The investigators hypothesize that compared to participants in the psychoeducation and TAU groups, those subjects exposed to an ICU diary, and those exposed to both ICU diary + psychoeducation conditions, will have significantly reduced rates of PTSD at follow-up. (3)The investigators hypothesize that participants exposed to the ICU diary + psychoeducation condition will have significantly lower rates of PTSD compared to those in the ICU diary alone condition.
Detailed description
This is a randomized controlled pilot study involving patients who are in the ICU, for a minimum of 72 hrs with > 24 hrs mechanical ventilation. As is common in ICU research, proxy consent will be obtained from family members upon ICU admission. Patients will be randomized to 4 different conditions (1) treatment as usual (TAU) (2) ICU diary (3) psychoeducation (4) ICU diary + psychoeducation. The ICU diary will be created and maintained by nurses and family members for each patient randomized to condition (2) and (4), and will be given to patients by a research nurse upon discharge from the ICU. The patients in conditions (3) and (4) will receive a psychoeducational brochure detailing general treatment and sedation patients receive in the ICU, and the psychological symptoms such as depression and PTSD that can occur after a stay in the ICU. This brochure will also be sent to their follow-up physician. Patients in all conditions will be assessed at one week post-ICU for recollection of delusional memories using ICU Memory Tool (ICUMT), at one- and three-month post-ICU for baseline PTSD symptoms using Impact of Events Scale-Revised (IES-R), a commonly used measure of PTSD symptomatology, as well as measures of anxiety/depression, social support, and general health. At one and three month follow-up, the investigators will also ask patients if they had contact with their health care providers/follow-up physicians, sought mental health treatment, their general impressions of the intervention they received (diary, psychoeducation, both), and whether/how often they reviewed the document (if in conditions 2-4). The investigators will ascertain feasibility from the health care provider and family perspective by appending a short questionnaire to the diary, to be filled out each time an entry is made.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ICU Diaries | Experimental | Behavioral: ICU DiaryA bound empty journal will be stored at the patient's bedside near the nurse charting area. All family members and ICU staff are invited to write in the ICU diary at any time. Instructions will be provided to the patient's family at the time of randomization and will be available at the bedside for reference. Staff instructions will be posted at charting area for staff. During the patient's stay in ICU, the diary will never leave the unit. Under no circumstances will any part of an ICU diary be duplicated. Research staff will take a photograph of the patient after consent is obtained and the photograph will be mounted on the first page of the diary. Photographs will be taken with a Polaroid camera; therefore there will be no other record of the photograph. |
| Psychoeducation | Experimental | Behavioral: PsychoeducationThe research nurse will provide a psychoeducational brochure to study participants at ICU discharge (if cognitive capacity is established) or 30 days after ICU discharge. If participants are not well enough 30 days post-discharge, they will be assessed every two weeks by research staff until the brochure is given to them. The brochure will describe procedures in the ICU (sedation, ventilation), and the delirium, hallucinations, and trauma that may result; as well as symptoms of PTSD post-ICU. It will provide instructions for follow-up, information, and emergency care. The brochure will instruct participants to contact their follow-up healthcare provider if they have any questions. The document will also be mailed to the participant's follow-up physician. |
| ICU Diary plus Psychoeducation | Experimental | Behavioral: ICU Diary, Behavioral: PsychoeducationParticipants will receive both ICU diary and psychoeducation interventions, with both documents provided at ICU-discharge, or 30 days post-discharge as above. |
| Treatment as Usual | No intervention | –No additional intervention to usual ICU care will be given. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age greater than 17 years
- enrolment within 72 hours of ICU admission
- time of ICU stay is predicted to be >72 hours by ICU treatment team
- greater than 24 hours mechanical ventilation required
- understand verbal and written English
Key exclusion criteria (5 listed)
- no caregiver/family available
- terminal illness with life expectancy of less than 6 months
- pre-existing cognitive impairment
- less than 24 hours of mechanical ventilation
- reason for ICU admission is suicide attempt / overdose
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 |
|---|---|---|
| ICU DiaryCreation of an ICU diary: A bound empty journal will be stored at the patient's bedside near the nurse charting area. All family members and ICU staff are invited to write in the ICU diary at any time. Procedure for diary writing will follow previous research (see www.icu-diary.org). | Behavioural | ICU Diaries, ICU Diary plus Psychoeducation |
| PsychoeducationThe psychoeducation brochure will describe procedures in the ICU (sedation, ventilation), and the delirium, hallucinations, and trauma that may result; as well as symptoms of PTSD post-ICU. It will provide instructions for follow-up, information, and emergency care. The brochure will instruct participants to contact their follow-up healthcare provider if they have any questions. | Behavioural | ICU Diary plus Psychoeducation, Psychoeducation |
Primary outcome
Feasibility - enrollment of 1-2 participants per month
Time frame: One year
To test the feasibility of ICU diaries in a Canadian ICU setting by asking nurses and family members about the process of creating the diary. Specifically, feasibility of diary will be determined by a survey about the usability, time spent, and general comments on using the diary. Surveys will be filled by each individual making a diary entry (visitors and hospital staff).
3 secondary outcomes
Efficacy at 90 days as determined by Impact of Event Scores (IES-R)
Time frame: 90 days
Change in IES-R 30 days post ICU discharge and access to follow up care at 90 days post ICU discharge
Time frame: 30 and 90 days post ICU Discharge
IES-R score of family member at 30 days post patient ICU discharge
Time frame: 30 days 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 25 Oct 2018.
- Background: PubMed 18774425Davydow DS, Gifford JM, Desai SV, Needham DM, Bienvenu OJ. Posttraumatic stress disorder in general intensive care unit survivors: a systematic review. Gen Hosp Psychiatry. 2008 Sep-Oct;30(5):421-34. doi: 10.1016/j.genhosppsych.2008.05.006. Epub 2008 Jul 30.
- Background: PubMed 17384929Jones C, Backman C, Capuzzo M, Flaatten H, Rylander C, Griffiths RD. Precipitants of post-traumatic stress disorder following intensive care: a hypothesis generating study of diversity in care. Intensive Care Med. 2007 Jun;33(6):978-85. doi: 10.1007/s00134-007-0600-8. Epub 2007 Mar 24.
- Background: PubMed 11396288Backman CG, Walther SM. Use of a personal diary written on the ICU during critical illness. Intensive Care Med. 2001 Feb;27(2):426-9. doi: 10.1007/s001340000692.
- 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 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 12961065Cuthbertson BH, Hull A, Strachan M, Scott J. Post-traumatic stress disorder after critical illness requiring general intensive care. Intensive Care Med. 2004 Mar;30(3):450-5. doi: 10.1007/s00134-003-2004-8. Epub 2003 Sep 5.
- Derived from this study: PubMed 30119073Kredentser MS, Blouw M, Marten N, Sareen J, Bienvenu OJ, Ryu J, Beatie BE, Logsetty S, Graff LA, Eggertson S, Sweatman S, Debroni B, Cianflone N, Arora RC, Zarychanski R, Olafson K. Preventing Posttraumatic Stress in ICU Survivors: A Single-Center Pilot Randomized Controlled Trial of ICU Diaries and Psychoeducation. Crit Care Med. 2018 Dec;46(12):1914-1922. doi: 10.1097/CCM.0000000000003367.
- Related InfoLink provided by the sponsor.
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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.
Marcus R Blouw, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU Diary and Psychoeducation in people with Stress Disorders, Post Traumatic and Anxiety, run by University of Manitoba at 1 site in Canada.
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 5 inclusion and 5 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 25 Oct 2018. 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 Canada. 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?
Feasibility - enrollment of 1-2 participants per month (time frame: One year). 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 NCT02067559, which also lists 7 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 25 Oct 2018.