"Stress disorders following prolonged critical illness in patients with severe sepsis (CRISIS)"

Group 1: Aims of the project will be the assessment of the incidence of Acute Stress Disorder (F43.0) and Post-Traumatic Stress Disorder (F43.1) in critical ill patients surviving severe sepsis with m

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: - patients with critical illness polyneuropathy or critical illness myopathy - severe sepsis with multiple organ failure (R65.1!) - men and women (18-70 years) - length of ICU stay > 5 days - sufficient German language skills - written informed consent of subjects or their carer

Exclusion criteria

Exclusion criteria: - patients, who are not alert, cognitive impaired, or with sensory deficits limiting their ability to communicate - minority - participation in another clinical study

Design outcomes

Primary

Measure	Time frame
- assessment of the incidence of acute stress disorder (F43.0) within four weeks after discharge from intensive care unit (ICU) using a valid diagnostic interview (SKID-I, Wittchen et al., 1997) to evaluate the magnitude of the problem in survivors of severe sepsis with multiple organ failure, being treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa./ - assessment of the incidence of post-traumatic stress disorder (F43.1) within three months after discharge from intensive care unit (ICU) using a valid diagnostic interview (SKID-I, Wittchen et al., 1997) to evaluate the magnitude of the problem in survivors of severe sepsis with multiple organ failure, treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa./ - Examination of the relationship between clinical (length of ICU stay in acute care hospital/ in post-rehab hospital, length of ventilation in acute care hospital/ in post-rehab hospital, Barthel-Index) and demographic (age, sex, marital status, educational level) variables with the diagnosis of acute stress disorder assessed by means of SKID-I (Wittchen et al., 1997)/ symptom scores assessed by means of Acute Stress Disorder Scale (Bryant et al., 2000) within four weeks after discharge from ICU./ - Examination of the relationship between clinical (length of ICU stay in acute care hospital/ in post-rehab hospital, length of ventilation in acute care hospital/ in post-rehab hospital, Barthel-Index), demographic (age, sex, marital status, educational level) and psychological variables [diagnosis of acute stress disorder (SKID-I), symptoms of acute stress disorder (ASDS)] with the diagnosis of post-traumatic stress disorder assessed by means of SKID-I (Wittchen et al., 1997)/ symptom scores assessed by means of Post-traumatic Stress Scale (PTSS-10, Maercker, 1998) within three months after ICU discharge. - Examination of the relationship between clinical (length	—

Measure

Time frame

- assessment of the incidence of acute stress disorder (F43.0) within four weeks after discharge from intensive care unit (ICU) using a valid diagnostic interview (SKID-I, Wittchen et al., 1997) to evaluate the magnitude of the problem in survivors of severe sepsis with multiple organ failure, being treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa./ - assessment of the incidence of post-traumatic stress disorder (F43.1) within three months after discharge from intensive care unit (ICU) using a valid diagnostic interview (SKID-I, Wittchen et al., 1997) to evaluate the magnitude of the problem in survivors of severe sepsis with multiple organ failure, treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa./ - Examination of the relationship between clinical (length of ICU stay in acute care hospital/ in post-rehab hospital, length of ventilation in acute care hospital/ in post-rehab hospital, Barthel-Index) and demographic (age, sex, marital status, educational level) variables with the diagnosis of acute stress disorder assessed by means of SKID-I (Wittchen et al., 1997)/ symptom scores assessed by means of Acute Stress Disorder Scale (Bryant et al., 2000) within four weeks after discharge from ICU./ - Examination of the relationship between clinical (length of ICU stay in acute care hospital/ in post-rehab hospital, length of ventilation in acute care hospital/ in post-rehab hospital, Barthel-Index), demographic (age, sex, marital status, educational level) and psychological variables [diagnosis of acute stress disorder (SKID-I), symptoms of acute stress disorder (ASDS)] with the diagnosis of post-traumatic stress disorder assessed by means of SKID-I (Wittchen et al., 1997)/ symptom scores assessed by means of Post-traumatic Stress Scale (PTSS-10, Maercker, 1998) within three months after ICU discharge. - Examination of the relationship between clinical (length

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Secondary

Measure	Time frame
- assessment of the preceived helplessness and fear of death within four weeks after ICU discharge in survivors of severe sepsis with multiple organ failure, being treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa./ - analysis of predictors of differential courses (persistence, remission, delayed onset, resistance) of post-traumatic stress disorder from 4 weeks to 6 months after ICU discharge following severe sepsis with multiple organ failure, being treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa. - evaluation of the need for mental health care in patients surviving severe sepsis with multiple organ failure, treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa and who have been identified as suffering from post-traumatic stress disorder three months or six months after ICU discharge (post-traumatic stress scale >35 as definition of a case)./ - assessment of the following psychological variables three months and six months after ICU discharge: current diagnosis of affective disorder (Major Depression, bipolar disorder) by means of SKID-I (Wittchen et al., 1997); symptoms of chronic fatigue by means of the Multidimensional Fatigue Inventory (MFI-20; Schwarz et al., 2003); traumatic memory of the ICU stay (Stoll et al., 1999); quality of life (EQ-5D; Rabin & de Charro, 2001); social support (Multidimensional Scale of Perceived Social Support, MSPSS; Zimet et al., 1988)./ - assessment of the following psychological variables six months after ICU discharge: life-time diagnosis of affective disorder (Major Depression, bipolar disorder) and post-traumatic stress disorder by means of SKID-I (Wittchen et al., 1997).	—

Measure

Time frame

- assessment of the preceived helplessness and fear of death within four weeks after ICU discharge in survivors of severe sepsis with multiple organ failure, being treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa./ - analysis of predictors of differential courses (persistence, remission, delayed onset, resistance) of post-traumatic stress disorder from 4 weeks to 6 months after ICU discharge following severe sepsis with multiple organ failure, being treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa. - evaluation of the need for mental health care in patients surviving severe sepsis with multiple organ failure, treated because of critical illness polyneuropathy or critical illness myopathy in the clinic Kreischa and who have been identified as suffering from post-traumatic stress disorder three months or six months after ICU discharge (post-traumatic stress scale >35 as definition of a case)./ - assessment of the following psychological variables three months and six months after ICU discharge: current diagnosis of affective disorder (Major Depression, bipolar disorder) by means of SKID-I (Wittchen et al., 1997); symptoms of chronic fatigue by means of the Multidimensional Fatigue Inventory (MFI-20; Schwarz et al., 2003); traumatic memory of the ICU stay (Stoll et al., 1999); quality of life (EQ-5D; Rabin & de Charro, 2001); social support (Multidimensional Scale of Perceived Social Support, MSPSS; Zimet et al., 1988)./ - assessment of the following psychological variables six months after ICU discharge: life-time diagnosis of affective disorder (Major Depression, bipolar disorder) and post-traumatic stress disorder by means of SKID-I (Wittchen et al., 1997).

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Countries

Germany

Contacts

Public ContactGloria-Beatrice Wintermann

Institut für Psychosoziale Medizin und Psychotherapie, Universitätsklinikum Jena; Klinik und Poliklinik für Psychosomatik und Psychotherapie, Universitätsklinikum Carl Gustav Carus Dresden

crisis-studie@web.de0351/ 458 2079; 0351/ 458 7059

Outcome results

None listed