Affect Management Group for Adult Survivors of Childhood Trauma

Sponsor
University of Zurich (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00383006
Collaborator
(none)
16
1
24
0.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date :
May 1, 2006
Anticipated Study Completion Date :
May 1, 2008

Outcome Measures

Primary Outcome Measures

  1. Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up) [2008]

Secondary Outcome Measures

  1. Score on depression at week 14 (post-interventional) and month 3 (follow-up) [2008]

  2. Score on life quality at week 14 (post-interventional) and month 3 (follow-up) [2008]

  3. Score on personal resources at week 14 (post-interventional) and month 3 (follow-up) [2008]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00383006
Other Study ID Numbers:
  • PSYUNIZH26092006
First Posted:
Oct 2, 2006
Last Update Posted:
Jun 3, 2009
Last Verified:
Jun 1, 2009

Study Results

No Results Posted as of Jun 3, 2009