Stress Disorders, Post-TraumaticPhase 1NCT00383006
Affect Management Group for Adult Survivors of Childhood Trauma
A Phase 1 study testing Skills for affect regulation (behavior) in people with Stress Disorders, Post-Traumatic, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- Skills for affect regulation (behavior)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2006to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe dissociation
- Environmental safety problems
- Ongoing enmeshment with perpetrators
- Psychotic disorders
- Severe depression
- Acute suicidality
- Substance abuse
- Severe cognitive decline
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Psychiatry, University Hospital
Zurich, Canton of Zurich, 8091
About this study
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.
Read the 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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- Skills for affect regulation (behavior)
- Keywords
- Psychotherapy, Group, Stress Disorders, Post-Traumatic, Ambulatory Care
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skills for affect regulation (behavior)Behavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up)
Measured: 2008
Secondary outcomes (3)
Score on depression at week 14 (post-interventional) and month 3 (follow-up)
Measured: 2008
Score on life quality at week 14 (post-interventional) and month 3 (follow-up)
Measured: 2008
Score on personal resources at week 14 (post-interventional) and month 3 (follow-up)
Measured: 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2006 (estimated)
- Study startMay 2006
- Study completionMay 2008 (estimated)
Why it stopped: Difficulties in finding enough study participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- Christoph Mueller, MD, Principal investigator, Department of Psychiatry, University Hospital, 8091 Zurich, SwitzerlandMichael Rufer, MD, Principal investigator, Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383006
- Sponsor's protocol ID
- PSYUNIZH26092006
- Status last verified
- Jun 2009
- First submitted
- 29 Sep 2006
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affect Management Group for Adult Survivors of Childhood Trauma
- ClinicalTrials.gov ID
- NCT00383006
- Acronym / sponsor ID
- PSYUNIZH26092006
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Psychotherapy, Group, Stress Disorders, Post-Traumatic, Ambulatory Care
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties in finding enough study participants.
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2006
- Study completion
- May 2008 (estimated)
- First posted
- 2 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Severe dissociation
- Environmental safety problems
- Ongoing enmeshment with perpetrators
- Psychotic disorders
- Severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skills for affect regulation (behavior) | Behavioural | – |
Primary outcome
Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up)
Time frame: 2008
3 secondary outcomes
Score on depression at week 14 (post-interventional) and month 3 (follow-up)
Time frame: 2008
Score on life quality at week 14 (post-interventional) and month 3 (follow-up)
Time frame: 2008
Score on personal resources at week 14 (post-interventional) and month 3 (follow-up)
Time frame: 2008
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christoph Mueller, MD principal investigator
Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland
Michael Rufer, MD principal investigator
Department of Psychiatry, University Hospital, 8091 Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Skills for affect regulation (behavior) in people with Stress Disorders, Post-Traumatic, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up) (time frame: 2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.