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Trials / Completed

CompletedNCT02450617

Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
158 (actual)
Sponsor
Modum Bad · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALConventional individual treatmentIndividual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist
BEHAVIORALStabilizing group treatment for PTSD20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training.
BEHAVIORALStabilizing group treatment for Dissociative disorders20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training

Timeline

Start date
2014-06-01
Primary completion
2019-09-01
Completion
2019-09-01
First posted
2015-05-21
Last updated
2019-09-27

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT02450617. Inclusion in this directory is not an endorsement.

Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial (NCT02450617) · Clinical Trials Directory