Affect Management Group for Adult Survivors of Childhood Trauma

Stress Disorders, Post-Traumatic Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00383006
• Other study ID #: PSYUNIZH26092006
• Status: Withdrawn
• Phase: Phase 1
• First received: September 29, 2006
• Last updated: June 2, 2009
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: June 2009
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 16
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Skills for affect regulation (behavior)

Locations

Country	Name	City	State
Switzerland	Department of Psychiatry, University Hospital	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up)		2008
Secondary	Score on depression at week 14 (post-interventional) and month 3 (follow-up)		2008
Secondary	Score on life quality at week 14 (post-interventional) and month 3 (follow-up)		2008
Secondary	Score on personal resources at week 14 (post-interventional) and month 3 (follow-up)		2008