ClinicalTrials.gov
ClinicalTrials.gov Menu

Affect Management Group for Adult Survivors of Childhood Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00383006
Recruitment Status : Withdrawn (Difficulties in finding enough study participants.)
First Posted : October 2, 2006
Last Update Posted : June 3, 2009
Sponsor:
Information provided by:
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Skills for affect regulation (behavior) Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2006
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up) [ Time Frame: 2008 ]

Secondary Outcome Measures :
  1. Score on depression at week 14 (post-interventional) and month 3 (follow-up) [ Time Frame: 2008 ]
  2. Score on life quality at week 14 (post-interventional) and month 3 (follow-up) [ Time Frame: 2008 ]
  3. Score on personal resources at week 14 (post-interventional) and month 3 (follow-up) [ Time Frame: 2008 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00383006


Locations
Switzerland
Department of Psychiatry, University Hospital
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Christoph Mueller, MD Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland
Principal Investigator: Michael Rufer, MD Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland

ClinicalTrials.gov Identifier: NCT00383006     History of Changes
Other Study ID Numbers: PSYUNIZH26092006
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by University of Zurich:
Psychotherapy, Group
Stress Disorders, Post-Traumatic
Ambulatory Care

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders