Patterns of PTSD in Adult Patients After Intensive Care

Intensive Care Unit Syndrome Clinical Trial

Official title:

Patterns of PTSD Over Time in Adult Intensive Care Patients - Observations From the RAPIT Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03915977
• Other study ID #: 18-000080
• Status: Completed
• Start date: December 2, 2012
• Est. completion date: December 1, 2015

Study information

• Verified date: December 2012
• Source: Holbaek Sygehus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study aims to describe adult patients' patterns of Post-traumatic stress disorder (PTSD) at discharge, 3, and 12 months after intensive care.

Description:

The present study is a secondary analysis of the RAPIT-trial study treating data from patients on Post-traumatic stress disorder (PTDS) (Jensen et al., 2016).

Design Observational study based on data from the RAPIT trial that is a non-blinded, multicentre, parallel-group RCT conducted between December 2012-2015, at 10 intensive care units (ICUs) in four out of five regions in Denmark.

Participants Patients were consecutively recruited during the first 18 months of the study. We included Danish-speaking adults (≥18 years) who received mechanically ventilated ≥48 hours and did not meet the baseline criteria of dementia. We excluded delirious patients unable to give informed consent at randomization, or patients, who were enrolled in other studies. A total of 386 adult patients were randomized to standard care (SC) plus a nurse-led intensive care recovery program or standard care alone after ICU discharge (190 intervention, 196 SC).

Outcomes In this study, we will describe variations in patients, who experience symptoms of PTSD at ICU-discharge, 3 and 12 months after intensive care based on the data collection in the RAPIT-trial (Jensen et al., 2016). We will report trial participants' symptoms of PTSD at baseline, three months and twelve months after Intensive care using the Harvard Trauma Questionnaire (HTQ) supplemented with descriptions of patients' experiences of PTSD. Symptoms of anxiety and depression were collected at 3 and 12 months, and utilization of healthcare services including mortality were obtained from hospital charts combined with self-reported data from patients. We will use descriptive statistical methods to analyze data.

Symptoms of PTSD by HTQ-IV consisted of 17 items covering three core symptoms corresponding to DSM-IV criteria for PTSD: re-experience (5 items), avoidance (7 items), and arousal (5 items). This was supplemented by four additional items: one functional and three related to stress. We used a total score, and a cut-off of ≥40 is categorized as "positive PTSD". Symptoms of anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) covering two dimensions: anxiety (7 items) and depression (7 items); subscale scores were 0-21 with higher scores reflecting greater psychological distress.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: December 1, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Non-invasive or invasive ventilation = 48 hours ( Non-ivasive ventilation (NIV) from current guidelines)

• Undiagnosed dementia

Exclusion Criteria:

• Delirium at randomization (positive CAM-ICU score)

• Participations in scientific projects which include patient interviews

• Not speaking or understanding danish.

Related Conditions & MeSH terms

• Intensive Care Unit Syndrome

Intervention

Behavioral:
• Post ICU recovery program
Standardized follow up program

Locations

Country	Name	City	State
Denmark	Holbæk Hospital	Holbæk	Sjælland

Sponsors (2)

Lead Sponsor	Collaborator
Holbaek Sygehus	Hillerod Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Jensen JF, Egerod I, Bestle MH, Christensen DF, Elklit A, Hansen RL, Knudsen H, Grode LB, Overgaard D. A recovery program to improve quality of life, sense of coherence and psychological health in ICU survivors: a multicenter randomized controlled trial, — View Citation

Jensen JF, Overgaard D, Bestle MH, Christensen DF, Rattray J, Egerod I. Intervention fidelity in postintensive care follow-up consultations at ten sites in the RAPIT-trial: A mixed-methods evaluation. J Adv Nurs. 2019 Apr;75(4):862-875. doi: 10.1111/jan.13949. Epub 2019 Feb 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post traumatic stress disorder (PTSD)	Harvard Trauma Questionnaire, Range 18-72	12 months
Secondary	Anxiety	Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21	12 months
Secondary	Anxiety	Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21	3 months
Secondary	Depression	Hospital Anxiety and Depression Scale (HADS) covering Depression (7 items) Range: 0-21	12 months
Secondary	Depression	Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21	3 months
Secondary	PTSD	Harvard Trauma Questionnaire, Range 18-72	Baseline
Secondary	PTSD	Harvard Trauma Questionnaire, Range 18-72	3 months
Secondary	PTSD	Change score using Harvard Trauma Questionnaire, Range 18-72	Over time at baseline, 3 and 12 months
Secondary	Anxiety	Change score Using Hospital Anxiety and Depression Scale (HADS) covering anxiety (7 items) Range: 0-21	Over time at 3 and 12 months
Secondary	Depression	Change score using Hospital Anxiety and Depression Scale (HADS) covering depression (7 items) Range: 0-21	Over time at 3 months and 12 months

External Links

•   Homepage for project collaborators