Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Launched by MONIQUE PFALTZ · Aug 8, 2024
Trial Information
Current as of August 20, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring a type of therapy called Somatic Experiencing (SE) for adults who have experienced child maltreatment and have symptoms of post-traumatic stress disorder (PTSD) or complex PTSD. The aim is to see if SE can help improve mental health and social functioning while ensuring the safety and acceptability of this treatment. Participants will be divided into two groups: one group will receive the SE therapy over 15 sessions, while the other group will receive regular phone calls for support. Researchers will evaluate how well the treatment works and monitor any potential side effects throughout the study.
To be eligible for this trial, participants must be 18 years or older, speak Swedish, and have access to a computer and the internet. They should also have a history of child maltreatment and moderate to severe PTSD symptoms. It's important to note that individuals with substance abuse issues, certain mental health conditions, or those currently receiving specific psychological treatments may not be eligible. Participants can expect to take part in assessments before, after, and a few months following the treatment to help researchers understand the effects of SE on their mental health and social experiences.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Adults (18 years or older).
- • Proficiency in Swedish Language.
- • Access to a computer/internet.
- • Meeting CTQ-cutoff for CM history (CTQ rating higher than 'none / minimal' in at least one of the subscales according to Bernstein and Fink (1998) (i.e. ≥10 for emotional neglect, ≥ 8 for physical neglect, ≥9 for emotional abuse, ≥8 for physical abuse and ≥6 for sexual abuse).
- • Meeting at least moderate/severe PTSD or complex PTSD symptoms on the ITQ.
- • If taking medication, it must have been ongoing for at least 3 months and the dose must have been stable for 1 month.
- • Signed informed consent provided.
- Exclusion Criteria:
- • Participants screen positive for alcohol (AUDIT) or substance abuse (DUDIT).
- • Psychotic symptoms, ongoing manic episode, acute suicidality.
- • If ongoing medication has an impact on the physiological data (ECG) recorded during the social paradigms, physiological data will be excluded from the analyses (but not exclusion for the treatment).
- • Have current (pre-assessment) ongoing psychological treatment focusing on social safeness, PTSD or complex PTSD.
About Monique Pfaltz
Monique Pfaltz is a dedicated clinical trial sponsor with a focus on advancing innovative medical research and improving patient outcomes. With extensive experience in managing and overseeing clinical trials, she is committed to ensuring compliance with regulatory standards while fostering collaboration among research teams. Monique’s expertise spans various therapeutic areas, and she is passionate about facilitating the development of new therapies through rigorous study design and efficient operational management. Her leadership is characterized by a strong emphasis on ethical practices, data integrity, and the prioritization of participant safety throughout the research process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stockholm, Stockholm County, Sweden
Patients applied
Trial Officials
Monique Pfaltz
Principal Investigator
+46101428300
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported