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:

* primary diagnosis of DSM-IV (American Psychiatric Association, 2000) criteria for chronic, PTSD (symptoms lasting 3 months or more)
* male, Veteran
* be free of psychosis and impaired cognitive function caused by traumatic brain injury or dementia

Exclusion Criteria:

* a current diagnosis of substance dependence or unstable bipolar disorder
* currently involved in psychosocial treatment for PTSD
B: Inclusion Criteria:

* 18 years of age or older
* Read and write English fluently
* Traumatic event related to military-duty, including combat, military training accidents, and military sexual trauma
* Transportation to attend meetings and available to complete study protocols
* Stable dose and type of PTSD medications for at least 6 weeks (per chart review)
* Willing to track medication changes during study

Exclusion Criteria:

* Inability to give informed, voluntary consent
* Cognitive impairment sufficient to cause inability to complete the protocol
* Psychotic symptoms
* Dementia or other organic mental disorders that may cause inability to complete the protocol
* Significant documented alcohol/substance abuse
* Presence of severe suicidal urges or intent
* Residence in a geographical area outside of San Diego County or Bedford, Massachusetts area
* Current daily practice of any skills of any meditation-based program - including, but not limited to:

  * Transcendental Meditation (TM)
  * Yoga
  * Tai Chi
  * Qi-Gong
  * Vipassana or Insight Meditation
  * Loving-Kindness or Compassion Meditation
  * Mindfulness-Based Stress Reduction (MBSR) or other mindfulness program
  * Guided Imagery
  * Mantram Repetition
  * Passage Meditation
  * Walking Meditation
  * Zen or Buddhist meditation
  * Self-hypnosis, Bio-feedback, etc.
* Other participant circumstances that, in the opinion of a consensus of the study team, would interfere with the safety of prospective participants or their need for treatment.
C: Inclusion Criteria:

* Veteran (female or male) from any era with a current diagnosis of PTSD due to MST
* Experienced MST no less than 3 months prior to entering the trial
* Identify that MST is the trauma that is causing the worst current distress (if other traumas also experienced)
* Have at least one clear memory of the trauma (sufficient to write impact statement)
* Consent to be randomized into treatment
* Not receive other psychotherapy during the 6 weeks of active treatment
* (if on psychoactive medications) if new antidepressant, be on stable medication regimen for a minimum of 6 weeks prior to entering the trial (if recent changes to antidepressant dosage or additions or changes of antipsychotic or anti-anxiety medication, eligible immediately)

Exclusion Criteria:

* Current substance dependence
* Prior substance dependence that has not been in remission for at least 3 months
* Any current psychotic symptoms
* Current mania or unstable Bipolar Disorder
* Prominent current suicidal or homicidal features
* Any severe cognitive impairment or history of Organic Mental Disorder
* Current involvement in a violent relationship
D: 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.

Answer: D