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Clinical Trials/NCT02450617
NCT02450617
Completed
Not Applicable

Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Modum Bad1 site in 1 country158 target enrollmentJune 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
Modum Bad
Enrollment
158
Locations
1
Primary Endpoint
Global Assessment of Functioning - change from baseline
Status
Completed
Last Updated
6 years ago

Overview

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 Description

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 treatment, how group climate influence symptoms, the relationship between individual and group therapy in combined treatment, and how treatment affects Heart Rate Variability. The investigators also seek to evaluate the treatment economically with a societal perspective, carrying out cost-utility analyses.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
September 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Modum Bad
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Heart rate variability- change from baseline(1 week after completed treatment)
  • PTSD Symptom Scale - Self-Report - change from baseline(6 months after completed treatment)
  • Short Form 36 - change from baseline(6 months after completed treatment)
  • Symptom Checklist 90 Revised - change from baseline(6 months after completed treatment)
  • Inventory of Interpersonal Problems - change from baseline(6 months after completed treatment)
  • Dissociative Experiences Scale II - change from baseline(6 months after completed treatment)
  • Behavior Checklist - change from baseline(6 months after completed treatment)
  • Heart rate variability - change from baseline(6 months after completed treatment)

Study Sites (1)

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