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

Primary Purpose

Posttraumatic Stress Disorder, Dissociative Identity Disorder, Dissociative Disorder

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Conventional individual treatment
Stabilizing group treatment for PTSD
Stabilizing group treatment for Dissociative disorders
Sponsored by
Modum Bad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Complex PTSD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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:

  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.

Sites / Locations

  • Traumepoliklinikken, Modum Bad i Oslo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Stabilizing group treatment for PTSD

Conventional Individual treatment - PTSD

Stabilizing group treatment for Dissociative disorders

Conventional Individual treatment - Dissociative disorders

Arm Description

Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment.

Conventional individual treatment.

Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment.

Conventional individual treatment.

Outcomes

Primary Outcome Measures

Global Assessment of Functioning - change from baseline
Daily life functioning and severity of symptoms last week, assessed by interview
Global Assessment of Functioning- change from baseline
Daily life functioning and severity of symptoms last week, assessed by interview

Secondary Outcome Measures

Heart rate variability- change from baseline
Resting state heart rate variability
Heart rate variability - change from baseline
Resting state heart rate variability
PTSD Symptom Scale - Self-Report - change from baseline
PTSD Symptom Scale - Self-Report - change from baseline
Symptom Checklist 90 Revised - change from baseline
Symptom Checklist 90 Revised - change from baseline
Inventory of Interpersonal Problems - change from baseline
Inventory of Interpersonal Problems - change from baseline
Dissociative Experiences Scale II - change from baseline
Dissociative Experiences Scale II - change from baseline
Behavior Checklist - change from baseline
registers function and self-destructive behavior
Behavior Checklist - change from baseline
registers function and self-destructive behavior
Short Form 36 - change from baseline
Short Form 36 - change from baseline

Full Information

First Posted
May 13, 2015
Last Updated
September 26, 2019
Sponsor
Modum Bad
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1. Study Identification

Unique Protocol Identification Number
NCT02450617
Brief Title
Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial
Acronym
STAB
Official Title
Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modum Bad

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Dissociative Identity Disorder, Dissociative Disorder
Keywords
Complex PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stabilizing group treatment for PTSD
Arm Type
Experimental
Arm Description
Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment.
Arm Title
Conventional Individual treatment - PTSD
Arm Type
Active Comparator
Arm Description
Conventional individual treatment.
Arm Title
Stabilizing group treatment for Dissociative disorders
Arm Type
Experimental
Arm Description
Group treatment, 20 sessions psychoeducation and skills-training. In combination with conventional individual treatment.
Arm Title
Conventional Individual treatment - Dissociative disorders
Arm Type
Active Comparator
Arm Description
Conventional individual treatment.
Intervention Type
Behavioral
Intervention Name(s)
Conventional individual treatment
Intervention Description
Individual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist
Intervention Type
Behavioral
Intervention Name(s)
Stabilizing group treatment for PTSD
Other Intervention Name(s)
"Back to here and now"
Intervention Description
20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training.
Intervention Type
Behavioral
Intervention Name(s)
Stabilizing group treatment for Dissociative disorders
Other Intervention Name(s)
"Coping with Trauma-Related Dissociation"
Intervention Description
20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training
Primary Outcome Measure Information:
Title
Global Assessment of Functioning - change from baseline
Description
Daily life functioning and severity of symptoms last week, assessed by interview
Time Frame
1 week after completed treatment
Title
Global Assessment of Functioning- change from baseline
Description
Daily life functioning and severity of symptoms last week, assessed by interview
Time Frame
6 months after completed treatment
Secondary Outcome Measure Information:
Title
Heart rate variability- change from baseline
Description
Resting state heart rate variability
Time Frame
1 week after completed treatment
Title
Heart rate variability - change from baseline
Description
Resting state heart rate variability
Time Frame
6 months after completed treatment
Title
PTSD Symptom Scale - Self-Report - change from baseline
Time Frame
1 week after completed treatment
Title
PTSD Symptom Scale - Self-Report - change from baseline
Time Frame
6 months after completed treatment
Title
Symptom Checklist 90 Revised - change from baseline
Time Frame
1 week after completed treatment
Title
Symptom Checklist 90 Revised - change from baseline
Time Frame
6 months after completed treatment
Title
Inventory of Interpersonal Problems - change from baseline
Time Frame
1 week after completed treatment
Title
Inventory of Interpersonal Problems - change from baseline
Time Frame
6 months after completed treatment
Title
Dissociative Experiences Scale II - change from baseline
Time Frame
1 week after completed treatment
Title
Dissociative Experiences Scale II - change from baseline
Time Frame
6 months after completed treatment
Title
Behavior Checklist - change from baseline
Description
registers function and self-destructive behavior
Time Frame
1 week after completed treatment
Title
Behavior Checklist - change from baseline
Description
registers function and self-destructive behavior
Time Frame
6 months after completed treatment
Title
Short Form 36 - change from baseline
Time Frame
1 week after completed treatment
Title
Short Form 36 - change from baseline
Time Frame
6 months after completed treatment
Other Pre-specified Outcome Measures:
Title
Use of health services - change from 6 months pre-treatment
Description
Assessed by data from Norwegian Patient Register
Time Frame
6 months after completed treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Traumepoliklinikken, Modum Bad i Oslo
City
Oslo
ZIP/Postal Code
0259
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
35578194
Citation
Baekkelund H, Ulvenes P, Boon-Langelaan S, Arnevik EA. Group treatment for complex dissociative disorders: a randomized clinical trial. BMC Psychiatry. 2022 May 16;22(1):338. doi: 10.1186/s12888-022-03970-8.
Results Reference
derived

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Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

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