Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Sertraline; Cognitive behavioral therapy (CBT)
Intervention description: Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks; CBT consists of sixteen 1-hour sessions during a period of 12 weeks.
Intervention MeSH terms: Sertraline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PTSD; Trauma; Sexual Abuse; Sexual Assault

Summary:

      This study will evaluate which parts of the brain are affected by treatment with behavioral
      therapy versus medication therapy in people with post-traumatic stress disorder.
    

Eligibility criteria:

        Inclusion Criteria:

        For people with PTSD:

          -  Meets DSM-IV criteria for PTSD

          -  Medically healthy

          -  Right handed

          -  Learned English prior to age 5

          -  Agrees to use an effective form of contraception throughout the study

        For healthy controls:

          -  Medically healthy

          -  Right handed

          -  Has experienced a qualifying traumatic event

          -  Does not meet DSM-IV criteria for present or past PTSD

          -  Learned English prior to age 5

          -  Agrees to use an effective form of contraception throughout the study

        Exclusion Criteria:

        For people with PTSD:

          -  Meets DSM-IV criteria for panic disorder within 6 months prior to study entry

          -  Current suicide risk

          -  History of DSM-IV diagnosis of any the following conditions: schizophrenia, bipolar
             mood disorder, obsessive compulsive disorder (including trichotillomania), or eating
             disorder

          -  Meets DSM-IV criteria for substance use or dependence within the 6 months prior to
             study entry

          -  Any substance abuse within 2 weeks prior to study entry

          -  Score of greater than 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D)
             with depressive symptoms secondary to PTSD

          -  Current participation in cognitive behavioral psychotherapy that is specifically
             designed to treat PTSD

          -  Concomitant psychoactive medications

          -  History of cerebrovascular accident (CVA) or any disorder that causes chronic
             neurological problems

          -  Medical illness with central nervous system (CNS) involvement or currently taking
             medication that affects the CNS

          -  Unstable general medical illness requiring intervention (e.g., HIV infection)

          -  Pregnant, breastfeeding, or plans to become pregnant

          -  Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets,
             surgical prostheses, surgical clips, or pins

          -  History of gastric bypass surgery

        For healthy controls:

          -  Any history of generalized anxiety disorder or panic disorder

          -  Any history of psychotic disorder, bipolar disorder, or cyclothymia

          -  Any history of substance abuse or dependence within the 6 months prior to study entry

          -  Any substance use within 2 weeks prior to study entry

          -  Any other Axis I disorder within the year prior to study entry, including
             obsessive-compulsive disorder and trichotillomania

          -  Unstable general medical illness requiring intervention (e.g., HIV infection)

          -  Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets,
             surgical prostheses, surgical clips, or pins

          -  Concomitant psychoactive medications

          -  Patients with a history of cerebrovascular accident (CVA) or any disorder that causes
             chronic neurological problems

          -  Medical illness with central nervous system (CNS) involvement or currently taking
             medication that affects the CNS

          -  Cognitive impairment or severe Axis II disorder that will likely affect participation
             in the study

          -  Pregnant, breastfeeding, or plans to become pregnant