Please select the eligibility criteria that correspond to the clinical trial below.
Title: CSP #494 - A Randomized Clinical Trial of Cognitive-Behavioral Treatment for PTSD in Women (PTSD)
Brief Summary: The purpose of the proposed DVA cooperative study is to evaluate the efficacy of exposure therapy for treating PTSD and associated problems in female veterans and active duty military personnel. We propose to compare exposure therapy, Prolonged Exposure, with a comparison therapy that focuses on current problems, Present Centered Therapy.

The study is a randomized clinical trial involving 384 female veterans and active duty personnel in 11 VA medical centers and 1 DoD medical center. All subjects, even self-referrals, will enter the study through referrals by mental health clinicians at the participating sites. Following informed consent, subjects will be screened for inclusion and exclusion diagnoses. If they meet these criteria and agree to participate, they will be randomly assigned to one of the two treatments, which will occur weekly for 10 weeks. Subjects will be assessed before treatment, immediately following treatment, and 3 and 6 months after the end of treatment. The primary outcome is PTSD severity. Secondary outcomes are anxiety and depression. Exploratory outcomes include associated features of PTSD, such as dissociation and substance abuse; psychosocial functioning, quality of life, physical health, satisfaction with treatment, and service utilization. Both treatments will be described in detail in a treatment manual and monitored intensively to ensure that they are administered correctly.


Options:
A: Inclusion Criteria:

* DSM-IV criteria for Post-Traumatic Stress Disorder related to childhood physical and/or sexual abuse by a care-giver
* At least one clear memory of the abuse
* Willing to have all assessments tape recorded and sessions video taped
* Willing to maintain any concurrent treatments for the duration of the study

Exclusion Criteria:

* Bipolar Disorder
* Eating Disorder
* Borderline Personality Disorder
* Active substance abuse or dependence
* Living with the abuser
* Self mutilation
* Pregnancy
B: Inclusion Criteria:

* Have current PTSD (within the past 6 months) in response to crime victimization, including childhood sexual or physical abuse, or meet criteria for PTSD in response to combat;
* Have a CAPS score showing moderate to severe PTSD symptoms;
* They must either:

  1. Have had at least one unsuccessful attempt at treatment for PTSD with a SSRI and psychotherapy;
  2. Be a veteran with PTSD symptoms that have endured for no less than one year but no more than five years
* Be at least 18 years old;
* Must be generally healthy;
* Willing to remain overnight at the study site;
* Agree to have transportation home the morning after experimental sessions;
* Are willing to be contacted via telephone for all necessary telephone contacts;
* Must have a negative pregnancy test if able to bear children and agree to use an effective form of birth control;
* Are proficient in reading English;

Exclusion Criteria:

* Are pregnant or nursing, or are able to bear children and are not practicing an effective means of birth control;
* Weigh less than 50 kg or more than 105 kg;
* Are unable to give adequate informed consent;
* Prior use of "Ecstasy" (illicit drug preparations purported to contain MDMA) more than 5 times or at any time within the previous 6 months;
* Have a history of certain excluded medical disorders.
C: Inclusion Criteria:

* female veterans or active duty personnel with a current diagnosis of PTSD due to any type of trauma;
* have experienced trauma no less than 3 months prior to entering the trial;
* have at least one clear memory of the trauma that caused their PTSD (sufficient for constructing a scene to be used in PE);
* consent to be randomized into treatment;
* not receive other psychotherapy for PTSD during the 10 weeks of active treatment;
* psychotherapy for other problems, brief check-ins with an existing therapist, and attendance at self-help groups will be allowed;
* if on psychoactive medication be on a stable medication regimen for a minimum of 2 months prior to entering the trial.

Exclusion Criteria:

* current substance dependence;
* prior substance dependence that has not been in remission at least 3 months;
* any current psychotic symptoms; current Mania or Bipolar Disorder;
* prominent current suicidal or homicidal ideation;
* any severe cognitive impairment or history of Organic Mental Disorder;
* current involvement in a violent relationship;
* self-mutilation within the past 6 months.
D: Inclusion Criteria:

* experiences of organized violence/torture
* PTSD diagnosis

Exclusion Criteria:

* psychotic disorder
* neurological disease or seizures
* current drug/alcohol abuse

Answer: C