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Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02450617
Acronym
STAB
Enrollment
158
Registered
2015-05-21
Start date
2014-06-30
Completion date
2019-09-30
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dissociative Disorder, Dissociative Identity Disorder, Posttraumatic Stress Disorder

Keywords

Complex PTSD

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.

Interventions

BEHAVIORALConventional individual treatment

Individual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist

BEHAVIORALStabilizing group treatment for PTSD

20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training.

BEHAVIORALStabilizing group treatment for Dissociative disorders

20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training

Sponsors

Modum Bad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* The inclusion criteria will be similar to clinical practice to ensure the external validity of the research. * participants must report a history of childhood abuse * be between 18 and 65 years of age * have enough competence in Norwegian to be able to participate in a psychoeducational group. * In the PTSD arm of the study patients must meet the criteria for a DSM - 5 diagnosis of Posttraumatic Stress Disorder. * In the Dissociative-disorders arm of the study the patients must meet criteria for a DSM-5 diagnosis of Dissociative Identity Disorder (DID) or Dissociative Disorder Not Otherwise Specified (DDNOS).

Exclusion criteria

will include: 1. Acute suicidality 2. Serious substance abuse interfering with treatment 3. Serious psychotic symptoms 4. Current life - crisis interfering with therapy (e.g. ongoing abuse, divorce, court case, somatic disease in spouse or children, etc.) 5. Neurological disease, mental disability or life threatening somatic disease. For the PTSD arm of the study an additional

Design outcomes

Primary

MeasureTime frameDescription
Global Assessment of Functioning- change from baseline6 months after completed treatmentDaily life functioning and severity of symptoms last week, assessed by interview
Global Assessment of Functioning - change from baseline1 week after completed treatmentDaily life functioning and severity of symptoms last week, assessed by interview

Secondary

MeasureTime frameDescription
Heart rate variability- change from baseline1 week after completed treatmentResting state heart rate variability
Heart rate variability - change from baseline6 months after completed treatmentResting state heart rate variability
PTSD Symptom Scale - Self-Report - change from baseline1 week after completed treatment
Dissociative Experiences Scale II - change from baseline1 week after completed treatment
Behavior Checklist - change from baseline1 week after completed treatmentregisters function and self-destructive behavior
Short Form 36 - change from baseline1 week after completed treatment
Inventory of Interpersonal Problems - change from baseline1 week after completed treatment
Symptom Checklist 90 Revised - change from baseline1 week after completed treatment

Other

MeasureTime frameDescription
Use of health services - change from 6 months pre-treatment6 months after completed treatmentAssessed by data from Norwegian Patient Register

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026