Stabilizing Group Treatment of Complex Trauma: A Randomized Controlled Trial

NCT ID: NCT02450617

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder Dissociative Identity Disorder Dissociative Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Stabilizing group treatment for PTSD

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

Group Type EXPERIMENTAL

Conventional individual treatment

Intervention Type BEHAVIORAL

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

Stabilizing group treatment for PTSD

Intervention Type BEHAVIORAL

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

Conventional Individual treatment - PTSD

Conventional individual treatment.

Group Type ACTIVE_COMPARATOR

Conventional individual treatment

Intervention Type BEHAVIORAL

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

Stabilizing group treatment for Dissociative disorders

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

Group Type EXPERIMENTAL

Conventional individual treatment

Intervention Type BEHAVIORAL

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

Stabilizing group treatment for Dissociative disorders

Intervention Type BEHAVIORAL

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

Conventional Individual treatment - Dissociative disorders

Conventional individual treatment.

Group Type ACTIVE_COMPARATOR

Conventional individual treatment

Intervention Type BEHAVIORAL

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

Interventions

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Conventional individual treatment

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

Intervention Type BEHAVIORAL

Stabilizing group treatment for PTSD

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

Intervention Type BEHAVIORAL

Stabilizing group treatment for Dissociative disorders

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

Intervention Type BEHAVIORAL

Other Intervention Names

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"Back to here and now" "Coping with Trauma-Related Dissociation"

Eligibility Criteria

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Inclusion Criteria

* 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

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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Modum Bad

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Traumepoliklinikken, Modum Bad i Oslo

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 35578194 (View on PubMed)

Other Identifiers

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Oslo

Identifier Type: -

Identifier Source: org_study_id

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