Clinical Trial: Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Brief Summary: The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with Post Traumatic Stress Disorder (PTSD) or dissociative disorders after childhood abuse. The investigators also aim to study psychophysiological markers associated with complex trauma and treatment, mechanisms of change involved in treatment, and which patient characteristics that predict positive outcome.

Detailed Summary:

Patients with histories of repeated traumatization in childhood often display a wide array of symptoms described as complex traumatic stress disorder. This sequela involves a high degree of comorbid mental and somatic disturbances, and entails tremendous health care costs for society and suffering for the victims. Despite the prevalence and consequences of complex trauma, research on effective treatments is extremely limited. Expert clinicians suggest that initial treatment for these patients should focus on stabilization of symptoms through psychoeducation and skills - training, and some research has supported this advice. Offering such treatment as group therapy can be both cost - effective and give patients additional peer-support. The research project outlined in this proposal aims to investigate the effectiveness of stabilizing group treatment as an add-on to conventional treatment, for patients with PTSD or dissociative disorders after childhood abuse. This will be investigated in a randomized controlled design. The investigators also aim to discover psychophysiological markers associated with treatment, mechanisms of change involved in treatment, and what patient characteristics that predict outcome. The results may contribute to new knowledge about treatment of complex traumatization, as well as new and improved health services for a vulnerable patient group with little specialized treatment today.

The main aim of this project is to compare the effectiveness of stabilizing group treatment as an add-on to conventional individual therapy, to conventional individual therapy alone, in a randomized controlled design. This will be tested in two independent diagnostic groups: Patients with PTSD and patients with Dissociative disorders, both groups with reports of childhood abuse. The investigators will further investigate how level of dissociative symptoms influence trea
Sponsor: Modum Bad

Current Primary Outcome:

  • Global Assessment of Functioning - change from baseline [ Time Frame: 1 week after completed treatment ]
    Daily life functioning and severity of symptoms last week, assessed by interview
  • Global Assessment of Functioning- change from baseline [ Time Frame: 6 months after completed treatment ]
    Daily life functioning and severity of symptoms last week, assessed by interview


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Heart rate variability- change from baseline [ Time Frame: 1 week after completed treatment ]
    Resting state heart rate variability
  • Heart rate variability - change from baseline [ Time Frame: 6 months after completed treatment ]
    Resting state heart rate variability
  • PTSD Symptom Scale - Self-Report - change from baseline [ Time Frame: 1 week after completed treatment ]
  • PTSD Symptom Scale - Self-Report - change from baseline [ Time Frame: 6 months after completed treatment ]
  • Symptom Checklist 90 Revised - change from baseline [ Time Frame: 1 week after completed treatment ]
  • Symptom Checklist 90 Revised - change from baseline [ Time Frame: 6 months after completed treatment ]
  • Inventory of Interpersonal Problems - change from baseline [ Time Frame: 1 week after completed treatment ]
  • Inventory of Interpersonal Problems - change from baseline [ Time Frame: 6 months after completed treatment ]
  • Dissociative Experiences Scale II - change from baseline [ Time Frame: 1 week after completed treatment ]
  • Dissociative Experiences Scale II - change from baseline [ Time Frame: 6 months after completed treatment ]
  • Behavior Checklist - change from baseline [ Time Frame: 1 week after completed treatment ]
    registers function and self-destructive behavior
  • Behavior Checklist - change from baseline [ Time Frame: 6 months after completed treatment ]
    registers function and self-destructive behavior
  • Short Form 36 - change from baseline [ Time Frame: 1 week after completed treatment ]
  • Short Form 36 - change from baseline [ Time Frame: 6 months after completed treatment ]


Original Secondary Outcome: Same as current

Information By: Modum Bad

Dates:
Date Received: May 13, 2015
Date Started: June 2014
Date Completion: June 2018
Last Updated: May 3, 2017
Last Verified: May 2017