Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries

Depression Clinical Trial

Official title: Preventing Post-traumatic Stress in ICU Survivors: A Pilot Randomized Controlled Trial of ICU Diaries

Status Completed

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anxiety
• Depression
• Quality of Life
• Stress Disorders, Post Traumatic
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT02067559
• Study type: Interventional
• Source: University of Manitoba
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: November 2016