NCT02450617

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

5.3 years

First QC Date

May 13, 2015

Last Update Submit

September 26, 2019

Conditions

Posttraumatic Stress DisorderDissociative Identity DisorderDissociative Disorder

Keywords

Complex PTSD

Outcome Measures

Primary Outcomes (2)

  • Global Assessment of Functioning - change from baseline

    Daily life functioning and severity of symptoms last week, assessed by interview

    1 week after completed treatment

  • Global Assessment of Functioning- change from baseline

    Daily life functioning and severity of symptoms last week, assessed by interview

    6 months after completed treatment

Secondary Outcomes (14)

  • Heart rate variability- change from baseline

    1 week after completed treatment

  • Heart rate variability - change from baseline

    6 months after completed treatment

  • PTSD Symptom Scale - Self-Report - change from baseline

    1 week after completed treatment

  • PTSD Symptom Scale - Self-Report - change from baseline

    6 months after completed treatment

  • Symptom Checklist 90 Revised - change from baseline

    1 week after completed treatment

  • +9 more secondary outcomes

Other Outcomes (1)

  • Use of health services - change from 6 months pre-treatment

    6 months after completed treatment

Study Arms (4)

Stabilizing group treatment for PTSD

EXPERIMENTAL

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

Behavioral: Conventional individual treatmentBehavioral: Stabilizing group treatment for PTSD

Conventional Individual treatment - PTSD

ACTIVE COMPARATOR

Conventional individual treatment.

Behavioral: Conventional individual treatment

Stabilizing group treatment for Dissociative disorders

EXPERIMENTAL

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

Behavioral: Conventional individual treatmentBehavioral: Stabilizing group treatment for Dissociative disorders

Conventional Individual treatment - Dissociative disorders

ACTIVE COMPARATOR

Conventional individual treatment.

Behavioral: Conventional individual treatment

Interventions

Conventional individual treatmentBEHAVIORAL

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

Conventional Individual treatment - Dissociative disordersConventional Individual treatment - PTSDStabilizing group treatment for Dissociative disordersStabilizing group treatment for PTSD
Stabilizing group treatment for PTSDBEHAVIORAL

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

Also known as: "Back to here and now"
Stabilizing group treatment for PTSD
Stabilizing group treatment for Dissociative disordersBEHAVIORAL

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

Also known as: "Coping with Trauma-Related Dissociation"
Stabilizing group treatment for Dissociative disorders

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Traumepoliklinikken, Modum Bad i Oslo

Oslo, 0259, Norway

Location

Related Publications (1)

  • 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.

    PMID: 35578194DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDissociative Identity DisorderDissociative Disorders

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2015

First Posted

May 21, 2015

Study Start

June 1, 2014

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

NO(1)