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Search / Trial NCT06549777

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

Safety Feasibility Body Oriented Intervention Somatic Experiencing Psychological Safety Social Safeness Childhood Maltreatment Post Traumatic Stress Disorder Complex Post Traumatic Stress Disorder Interoception Depression

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.

Locations

Stockholm, Stockholm County, Sweden

Patients applied

0 patients applied

Trial Officials

Monique Pfaltz

Principal Investigator

+46101428300

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported