The Trauma Recovery and Empowerment Model for Treating Post-Traumatic Stress Disorder in Women
Condition: Post-Traumatic Stress Disorder; Mental Disorders; Depression
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine the effectiveness of the Trauma Recovery and Empowerment Model in
      reducing the severity of post-traumatic stress disorder symptoms in women with mental
      disorders and who have experienced sexual or physical abuse.
    

Detailed description: 
      Post-traumatic stress disorder (PTSD) is an anxiety disorder that can develop after exposure
      to a terrifying event in which grave physical harm occurred or was threatened. Rates of PTSD
      are extremely high among people with severe mental disorders and such individuals find
      themselves at increased risk for depression, substance abuse, and poor overall health. In
      turn, these issues lead to high rates of utilization of mental health services.
      Unfortunately, there is currently a lack of effective trauma treatments that can be
      implemented in routine mental health settings. Trauma Recovery and Empowerment Model (TREM)
      is a group-based intervention that addresses PTSD and other closely related consequences of
      sexual and physical abuse among women with severe mental disorders. This study will determine
      the effectiveness of TREM in reducing the severity of PTSD symptoms in women with mental
      disorders who have experienced sexual or physical abuse.

      Participants in this open label study will be randomly assigned to receive either usual care
      alone or usual care combined with TREM for 18 months. Usual care will include medication,
      case management, and therapy administered by a primary clinician. Participants assigned to
      usual care will report to the study site at least once a week, or as often as necessary.
      Participants assigned to usual care plus TREM will also be assigned to a primary clinician
      and will receive usual care as often as necessary. In addition, TREM participants will take
      part in 29 group sessions that will focus on increasing self-esteem and trauma-coping skills
      and reducing self-blame. PTSD symptom severity, trauma beliefs, depressive symptoms,
      substance use, and mental health service utilization will be measured at Months 6, 12, and 18
      for all participants.
    

Intervention name(s): Trauma Recovery and Empowerment Model (TREM); Usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): TREM is a 29-session group intervention for women who have experienced psychological trauma (e.g., childhood physical or sexual abuse), focusing on skill development, understanding the effects of trauma, and empowerment.; Participants will receive usual care for women who have experienced psychological trauma.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PTSD; Physical Abuse; Sexual Abuse; Women; Trauma; Group Therapy; Substance Abuse