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

Sponsor

Modum Bad (Other)

Overall Status

Completed

CT.gov ID

NCT02450617

Collaborator

(none)

158

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Dissociative Identity Disorder Dissociative Disorder	Behavioral: Conventional individual treatment Behavioral: Stabilizing group treatment for PTSD Behavioral: Stabilizing group treatment for Dissociative disorders	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Sep 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Heart rate variability- change from baseline [1 week after completed treatment]
Resting state heart rate variability
Heart rate variability - change from baseline [6 months after completed treatment]
Resting state heart rate variability
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 [1 week after completed treatment]
registers function and self-destructive behavior
Behavior Checklist - change from baseline [6 months after completed treatment]
registers function and self-destructive behavior
Short Form 36 - change from baseline [1 week after completed treatment]
Short Form 36 - change from baseline [6 months after completed treatment]

Other Outcome Measures

Use of health services - change from 6 months pre-treatment [6 months after completed treatment]
Assessed by data from Norwegian Patient Register

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.