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Completed

NCT Number: NCT02450617

Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Traumepoliklinikken, Modum Bad i Oslo

Oslo, 0259, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Conventional individual treatment

Behavioral

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

Stabilizing group treatment for PTSD

Behavioral

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

Other names: "Back to here and now"

Stabilizing group treatment for Dissociative disorders

Behavioral

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

Other names: "Coping with Trauma-Related Dissociation"

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Modum Bad

Other

Registry information

Acronym: STAB

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 21, 2015
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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