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

September 26, 2019 updated by: Modum Bad
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0259
        • Traumepoliklinikken, Modum Bad i Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 week after completed treatment
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
6 months after completed treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heart rate variability- change from baseline
Time Frame: 1 week after completed treatment
Resting state heart rate variability
1 week after completed treatment
Heart rate variability - change from baseline
Time Frame: 6 months after completed treatment
Resting state heart rate variability
6 months after completed treatment
PTSD Symptom Scale - Self-Report - change from baseline
Time Frame: 1 week after completed treatment
1 week after completed treatment
PTSD Symptom Scale - Self-Report - change from baseline
Time Frame: 6 months after completed treatment
6 months after completed treatment
Symptom Checklist 90 Revised - change from baseline
Time Frame: 1 week after completed treatment
1 week after completed treatment
Symptom Checklist 90 Revised - change from baseline
Time Frame: 6 months after completed treatment
6 months after completed treatment
Inventory of Interpersonal Problems - change from baseline
Time Frame: 1 week after completed treatment
1 week after completed treatment
Inventory of Interpersonal Problems - change from baseline
Time Frame: 6 months after completed treatment
6 months after completed treatment
Dissociative Experiences Scale II - change from baseline
Time Frame: 1 week after completed treatment
1 week after completed treatment
Dissociative Experiences Scale II - change from baseline
Time Frame: 6 months after completed treatment
6 months after completed treatment
Behavior Checklist - change from baseline
Time Frame: 1 week after completed treatment
registers function and self-destructive behavior
1 week after completed treatment
Behavior Checklist - change from baseline
Time Frame: 6 months after completed treatment
registers function and self-destructive behavior
6 months after completed treatment
Short Form 36 - change from baseline
Time Frame: 1 week after completed treatment
1 week after completed treatment
Short Form 36 - change from baseline
Time Frame: 6 months after completed treatment
6 months after completed treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Use of health services - change from 6 months pre-treatment
Time Frame: 6 months after completed treatment
Assessed by data from Norwegian Patient Register
6 months after completed treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Modum Bad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Oslo

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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