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

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ClinicalTrials.gov Identifier: NCT02450617
Recruitment Status : Enrolling by invitation
First Posted : May 21, 2015
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
Modum Bad

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 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 : June 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


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 Name: "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 Name: "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




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Heart rate variability- change from baseline [ Time Frame: 1 week after completed treatment ]
    Resting state heart rate variability

  2. Heart rate variability - change from baseline [ Time Frame: 6 months after completed treatment ]
    Resting state heart rate variability

  3. PTSD Symptom Scale - Self-Report - change from baseline [ Time Frame: 1 week after completed treatment ]
  4. PTSD Symptom Scale - Self-Report - change from baseline [ Time Frame: 6 months after completed treatment ]
  5. Symptom Checklist 90 Revised - change from baseline [ Time Frame: 1 week after completed treatment ]
  6. Symptom Checklist 90 Revised - change from baseline [ Time Frame: 6 months after completed treatment ]
  7. Inventory of Interpersonal Problems - change from baseline [ Time Frame: 1 week after completed treatment ]
  8. Inventory of Interpersonal Problems - change from baseline [ Time Frame: 6 months after completed treatment ]
  9. Dissociative Experiences Scale II - change from baseline [ Time Frame: 1 week after completed treatment ]
  10. Dissociative Experiences Scale II - change from baseline [ Time Frame: 6 months after completed treatment ]
  11. Behavior Checklist - change from baseline [ Time Frame: 1 week after completed treatment ]
    registers function and self-destructive behavior

  12. Behavior Checklist - change from baseline [ Time Frame: 6 months after completed treatment ]
    registers function and self-destructive behavior

  13. Short Form 36 - change from baseline [ Time Frame: 1 week after completed treatment ]
  14. Short Form 36 - change from baseline [ Time Frame: 6 months after completed treatment ]

Other Outcome Measures:
  1. Use of health services - change from 6 months pre-treatment [ Time Frame: 6 months after completed treatment ]
    Assessed by data from Norwegian Patient Register



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 exclusion criteria will be that the patient meets the criteria for a dissociative disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450617


Locations
Norway
Traumepoliklinikken, Modum Bad i Oslo
Oslo, Norway, 0259
Sponsors and Collaborators
Modum Bad

Responsible Party: Modum Bad
ClinicalTrials.gov Identifier: NCT02450617     History of Changes
Other Study ID Numbers: Oslo
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: May 2017

Keywords provided by Modum Bad:
Complex PTSD

Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic
Dissociative Disorders
Conversion Disorder
Multiple Personality Disorder
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Somatoform Disorders