Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Study 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.

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

Conditions
-----------------
Posttraumatic Stress Disorder, Dissociative Identity Disorder, Dissociative Disorder

Intervention / Treatment
-----------------
* Behavioral: Conventional individual treatment
* Behavioral: Stabilizing group treatment for PTSD
* Behavioral: Stabilizing group treatment for Dissociative disorders


Participation Criteria
=================
Eligibility 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: Acute suicidality Serious substance abuse interfering with treatment Serious psychotic symptoms Current life - crisis interfering with therapy (e.g. ongoing abuse, divorce, court case, somatic disease in spouse or children, etc.) Neurological disease, mental disability or life threatening somatic disease. For the PTSD arm of the study an additional exclusion criteria will be that the patient meets the criteria for a dissociative disorder.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stabilizing group treatment for PTSD<br>Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment. | Behavioral: Conventional individual treatment<br>* Individual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist<br>Behavioral: Stabilizing group treatment for PTSD<br>* 20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training.<br>* Other names: Back to here and now;|
| Active Comparator: Conventional Individual treatment - PTSD<br>Conventional individual treatment. | Behavioral: Conventional individual treatment<br>* Individual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist<br>|
| Experimental: Stabilizing group treatment for Dissociative disorders<br>Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment. | Behavioral: Conventional individual treatment<br>* Individual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist<br>Behavioral: Stabilizing group treatment for Dissociative disorders<br>* 20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training<br>* Other names: Coping with Trauma-Related Dissociation;|
| Active Comparator: Conventional Individual treatment - Dissociative disorders<br>Conventional individual treatment. | Behavioral: Conventional individual treatment<br>* Individual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Functioning - change from baseline | Daily life functioning and severity of symptoms last week, assessed by interview | 1 week after completed treatment | 
| Global Assessment of Functioning- change from baseline | Daily life functioning and severity of symptoms last week, assessed by interview | 6 months after completed treatment | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Complex PTSD