Depression Clinical Trial
— QUADERNOfficial title:
Efficacy of the Use of Diaries in Intensive Care Units
Randomized clinical trial that aims to evaluate the impact of the use of a diary in patients and relatives of patients admitted to an ICU in relation to usual practice in terms of health-related quality of life, the post-traumatic stress and anxiety/depression at 2, 6 and 12 months after ICU discharge.
Status | Recruiting |
Enrollment | 240 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - admitted intensive care unit - sedated and mechanically ventilated for 24hours - signed consent - not language barrier - willingness to attend follow-up visits Exclusion Criteria: - verbal manifestation of psychiatric, mental or cognitive antecedents - who do not coluntarily agree to participate |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University of Barcelona |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospital Anxiety and Depression Scale (HADS) | questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin. | 2 months | |
Primary | Hospital Anxiety and Depression Scale (HADS) | questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin. | 6 months | |
Primary | Hospital Anxiety and Depression Scale (HADS) | questionnaries, range of 0-21 for either anxiety and depression subscores. Higher scores corresponding to worse outcomes. 0-7 normal; 8-10 borderline abnormal; 11-21 sever symptoms of anxiety or depressin. | 12 months | |
Primary | SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 2 months | |
Primary | SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 6 months | |
Primary | SF-36 Health Survey | questionnaries to measure quality of life. 36 items. from 0 to 100, with 100 being the best health | 12 months | |
Primary | Revised Impact of Event Scales (IES-R) | questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms. | 2 months | |
Primary | Revised Impact of Event Scales (IES-R) | questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms. | 6 months | |
Primary | Revised Impact of Event Scales (IES-R) | questionnaries; measuring areas of hyperarousal, avoidance, and intrusion as subscales. Total score ranges from 0-88, higher score associated with worse PTSD symptoms. 1-22 mild PTSD,;22 signal clinically significant PTSD symptoms. | 12 months |
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