NCT00383006

Brief Summary

Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. The study intends to evaluate the efficiency of a 14-week group therapy for adult survivors of relational trauma in childhood. Main interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills for affect regulation and techniques for activating resources. The hypothesis is that the group therapy significantly improves the participant's capacity in emotion management and self-soothing.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 2, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 3, 2009

Status Verified

June 1, 2009

First QC Date

September 29, 2006

Last Update Submit

June 2, 2009

Conditions

Stress Disorders, Post-Traumatic

Keywords

Psychotherapy, GroupStress Disorders, Post-TraumaticAmbulatory Care

Outcome Measures

Primary Outcomes (1)

  • Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up)

    2008

Secondary Outcomes (3)

  • Score on depression at week 14 (post-interventional) and month 3 (follow-up)

    2008

  • Score on life quality at week 14 (post-interventional) and month 3 (follow-up)

    2008

  • Score on personal resources at week 14 (post-interventional) and month 3 (follow-up)

    2008

Interventions

Skills for affect regulation (behavior)BEHAVIORAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with moderate to severe relational trauma in childhood (emotional, sexual or physical abuse, emotional or physical neglect)
  • DSM-IV diagnosis of posttraumatic stress disorder

You may not qualify if:

  • Severe dissociation
  • Environmental safety problems
  • Ongoing enmeshment with perpetrators
  • Psychotic disorders
  • Severe depression
  • Acute suicidality
  • Substance abuse
  • Severe cognitive decline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, University Hospital

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Christoph Mueller, MD

    Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

  • Michael Rufer, MD

    Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2006

First Posted

October 2, 2006

Study Start

May 1, 2006

Study Completion

May 1, 2008

Last Updated

June 3, 2009

Record last verified: 2009-06

Locations

CH(1)