N/A
N=261
Improving Psychological Distress Among Critical Illness Survivors and Their Caregivers
Intensive Care Unit Survivors · Informal Caregivers (Family and Friends)
Bottom Line
View on ClinicalTrials.gov: NCT01983254 ↗Enrolled (actual)
261
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Hospital Anxiety and Depression Scale Score — 16.6; 15.3; 15.6; 15.9 units on a scale (HADS summary score)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- coping skills training (Behavioral); education program (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Anxiety and Depression Scale Score |
16.6; 15.3; 15.6; 15.9 | — |
| SECONDARY Impact of Events Scale-revised (IES-R) Score |
31.0; 27.9; 29.4; 25.8 | — |
Summary
Patients who receive life support in intensive care units commonly suffer from persistent depression, anxiety, and post-traumatic stress disorder (PTSD) symptoms after discharge. We are trying to learn which is a better way to manage this distress: a telephone-based adaptive coping skills training program or an educational program.
Eligibility Criteria
Patient inclusion criteria:
- age >=18 and
- mechanical ventilation for more than 48 consecutive hours
Patient exclusions (pre-consent):
- current significant cognitive impairment (>=3 errors on the Callahan scale) or lacks decisional capacity
- pre-existing significant cognitive impairment
- residence at location other than home before hospital admission
- need for a translator because of poor English fluency [many study instruments are not validated in other languages]
- expected survival =18 years
- person most likely to provide the most post-discharge care.
Exclusions for caregivers are:
- history of significant cognitive impairment
- English fluency poor enough to require a medical translator
Informal caregiver exclusion criteria present after consent but before randomization:
- no longer available
- become too ill to participate
- exhibit suicidality
A total of 200 patient-caregiver dyads (total cohort = 400) are targeted
Data sourced from ClinicalTrials.gov (NCT01983254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.