Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial of a Brief Cognitive Behavioral Intervention Designed to Prevent and Reduce Symptoms of Posttraumatic Stress in Mothers of Preterm Infants.
Brief Summary: The purpose of the study includes:

1. To develop a treatment manual and pilot test this treatment intervention which is designed to prevent and reduce psychological distress in parents who have infants hospitalized in the neonatal intensive care unit (NICU).
2. To conduct a treatment intervention study in which parents of NICU infants will receive a 6-12 session treatment designed to reduce psychological distress, and to compare outcomes with parents who do not receive the intervention.

We hope to learn whether or not a simple psychotherapeutic and psychoeducational intervention offered to parents of NICU infants can prevent or minimize the development of symptoms of psychological distress in parents, including symptoms of anxiety and depression and posttraumatic stress disorder (PTSD).


Options:
A: Inclusion Criteria:

English and Spanish-speaking mothers greater than 18 years of age of infants in the LPCH NICU \>=26 weeks of gestation are eligible for screening.

Exclusion Criteria:

1. Mothers of children awaiting cardiac surgery, those who have congenital abnormities and those who are unlikely to survive, will be excluded.
2. Mothers of NICU infants who are found on their routine clinical psychosocial evaluation to be at high psychiatric risk (i.e., those with either psychotic symptoms or suicidal or infanticidal ideation) will also be excluded. These parents, however, will be referred for and receive appropriate mental health intervention.
3. Mothers who do not speak English or Spanish, or who do not have the ability to understand the questionnaires will be excluded.
4. Mothers who have active and current symptoms of suicidal ideation, or psychotic symptoms (delusions or hallucinations) as identified by self report or following a diagnostic interview will be excluded from the study, but will also be referred for emergency psychiatric evaluation.
B: Inclusion Criteria (the investigators will target patients at high risk for psychological distress):

* age ≥18 years
* acute cardiorespiratory failure managed in an intensive care unit
* reside at home before hospital admission (i.e., not in a facility)

  * Respiratory failure, ≥1 of these:
* mechanical ventilation via endotracheal tube for ≥ 12 hours
* non-invasive ventilation (CPAP, BiPAP) for \> 4 hours in a 24 hour period provided for acute respiratory failure in an ICU (not for obstructive sleep apnea or other stable use)
* high flow nasal cannula or face mask O2 with FiO2 ≥ 0.5 for ≥4 hours

  * Cardiac / circulatory failure, ≥1 of these:
* use of vasopressors for shock of any etiology for \> 1 hour
* use of inotropes for shock of any etiology for \> 1 hour
* use of aortic balloon pump for cardiogenic shock

Exclusion Criteria (present before consent): Patients will be excluded if they have characteristics that would prohibit adequate participation including:

* pre-existing significant cognitive impairment (e.g., dementia)
* treated for severe or unstable mental illness within 6 months preceding current admission (e.g., depression with psychosis, suicidality, schizophrenia as per medical record)
* hospital inpatient within 3 months before current admission
* active substance abuse at the time of admission
* lack of decisional capacity \[\*'Decisional capacity' is defined as the ability to participate in effective decision making and provide informed consent. That is, in the judgment of the examiner, the patient, after reading the IRB approved patient consent document (or having it read to them) can (a) generally understand the terms of participation in the study: the purpose of the study, what will be required of study participants; the potential risks, benefits and alternatives of study participation; pros \& cons of study involvement and (b) can communicate a choice in his/her own words (or write on a communication board)\]
* current significant cognitive impairment (≥3 errors on the Callahan cognitive status screen; see below)
* need for a translator because of poor English fluency \[many study instruments are not validated in other languages\]
* expected survival \<6 months per attending physician
* ICU length of stay \>30 days
* lack of either:
* reliable or sufficient smartphone with cellular data plan or
* reliable computer online access plus telephone access
* unable to complete study procedures as determined by study staff
* discharge to a location other than a home setting
* complex medical care expected soon after discharge (e.g., multiple planned surgeries, transplantation evaluation (including outpatient daily cardiopulmonary rehabilitation), extensive travel needs for hemodialysis, disruptive chemotherapy or XRT regimen, etc)

Other issues relevant to the consent process:

* unable to approach patient for logistical reasons (e.g., off ward in test at time of approach, etc)
* patient discharged before consent could be obtained
* patient dies before consent obtained

Patient exclusion criteria present after consent but before randomization:

After providing informed consent, patients will become ineligible if any of the following are present:

* they become too ill to participate (or die)
* they exhibit significant cognitive disability
* they exhibit suicidality
* patient was unexpectedly discharged to location other than a home setting and then did not arrive home within 1 month from hospital discharge
C: Inclusion Criteria:

* Presenting to the emergency department of Emory University School of Medicine/Grady Memorial Hospital for rape in the past 72 hours
* Meets DSM-IV diagnostic criterion A in which both of the following are present: (i) The person experienced, witnessed, or was confronted with an event or events that involved actual or threatened death or serious injury or a threat to the physical integrity of self or others (ii) The person's response involved intense fear, helplessness, or horror
* Speaks and understands spoken English
* Can see the assessment forms, hear instructions, and function at an emotional and intellectual level sufficient to allow accurate completion of all assessment instruments
* No significant traumatic injuries, as determined by the physician

Exclusion Criteria:

* Current or history of mania, schizophrenia, or other psychoses
* Current (past month) prominent suicidal ideation or recent (past 3 months) parasuicidal behavior or other self-injurious behavior, such as low lethality cutting
* Current (past month) substance dependence; people who meet criteria for current substance abuse but not dependence, or past dependence and have been in remission for at least 1 month are eligible.
* Experienced a loss of consciousness for more than 5 minutes as a result of injuries sustained during the trauma
* Intoxicated, altered, or highly distressed to the degree that accurate completion of the study assessments or participation in study procedures is not possible
* Blood alcohol level above .08, determined by breathalyzer in the emergency department
* Not alert, oriented, and coherent
* In severe pain, active labor, or respiratory distress or hemodynamically compromised in any way
D: Inclusion Criteria:

Patients:

* Expected to stay in ICU \> 48 hours
* Expected to be on ventilator \> 24 hours
* Has a close relative \> 18 years old
* Speaking and understanding Danish.
* Expected to be able to deliver an informed consent later

Relative:

\*Speaking and understanding Danish

Relative and patient are included in the study as a pair.

Exclusion Criteria:

* Patient staying less than 48 hours in ICU
* Patient less than 24 hours on ventilator
* Patient not able to give an informed consent to participate in study or patient dies in ICU (both relative and patient are excluded).

Answer: A