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Affect Management Group for Adult Survivors of Childhood Trauma

Primary Purpose

Stress Disorders, Post-Traumatic

Status
Withdrawn
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Skills for affect regulation (behavior)
Sponsored by
University of Zurich
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Psychotherapy, Group, Stress Disorders, Post-Traumatic, Ambulatory Care

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Department of Psychiatry, University Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 29, 2006
Last Updated
June 2, 2009
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT00383006
Brief Title
Affect Management Group for Adult Survivors of Childhood Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulties in finding enough study participants.
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. Since sufficient capacity for self soothing and emotional regulation are essential for trauma exposure, modern trauma therapy concepts are phase-oriented, beginning with working on "stabilization". 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. Inclusion criteria are clinical significant problems with self-regulation and the presence of childhood trauma. Outcome measures are based on self-rating questionnaires, clinical interviews and an experimental computer-task at timepoint pre-, post- and 3-month-follow-up. There is no control condition in the pilot-study phase.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
Psychotherapy, Group, Stress Disorders, Post-Traumatic, Ambulatory Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Skills for affect regulation (behavior)
Primary Outcome Measure Information:
Title
Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up)
Time Frame
2008
Secondary Outcome Measure Information:
Title
Score on depression at week 14 (post-interventional) and month 3 (follow-up)
Time Frame
2008
Title
Score on life quality at week 14 (post-interventional) and month 3 (follow-up)
Time Frame
2008
Title
Score on personal resources at week 14 (post-interventional) and month 3 (follow-up)
Time Frame
2008

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Severe dissociation Environmental safety problems Ongoing enmeshment with perpetrators Psychotic disorders Severe depression Acute suicidality Substance abuse Severe cognitive decline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Mueller, MD
Organizational Affiliation
Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Rufer, MD
Organizational Affiliation
Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University Hospital
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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Affect Management Group for Adult Survivors of Childhood Trauma

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