NCT06549777 Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
| NCT ID | NCT06549777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Monique Pfaltz |
| Condition | Safety, Psychological |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-09-06 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-09-06 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Pilot Randomized Controlled Trial (RCT) overall aim is to establish the safety, feasibility, acceptability and preliminary effects of a body-oriented psychotherapy, Somatic Experiencing (SE), on social functioning and mental health among adults with a history of Child Maltreatment (CM) and symptoms of posttraumatic stress disorder (PTSD) or complex posttraumatic stress disorder (CPTSD). Participants will be randomized either to an SE-group (n=25, psychoeducation, and information about treatment possibilities + 15-session SE treatment) or to a control group (n=25, same psychoeducation and information about treatment possibilities + regular phone calls to provide updates on their well-being and if they started a treatment). Given the lack of research on the effect of SE on Psychological Safety in this population, while SE has not yet been introduced into the Swedish health care system, special consideration will be given to participant safety, feasibility and acceptability of the SE-treatment. This includes monitoring (and assessing) for serious adverse events (SAEs) and adverse events (AEs), if conducting an RCT on SE in our target sample is feasible (e.g., achieving the target sample goal, assessing attrition rates and session attendance) and the acceptance of the used SE intervention (e.g., positive evaluations and willingness to recommend the treatment). Next to assessing safety, feasibility and acceptability, preliminary outcomes (self-report and experimental measures) will be evaluated at pre-treatment, post-treatment (20 weeks after pre), and at a 20-week follow-up, assessing primary outcomes (Psychological Safety) and secondary outcomes (Social Safeness, PTSD, CPTSD, Depression), as well as additional factors (e.g., interoception) that could contribute to decreased mental health and social functioning issues. Additionally, participants' behavioral (e.g., interpersonal distance) and physiological responses (HR, HRV, EDA) to social stimuli will be assessed pre- and post-treatment in an experimental setup to explore SE's potential to reduce Negative Affect and increase Positive Affect (Activated, Relaxed, Safe/Content) in response to social stress.
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.
Contact & Investigator
Monique Pfaltz
PRINCIPAL INVESTIGATOR
+46101428300
Frequently Asked Questions
Who can join the NCT06549777 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Safety, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06549777 currently recruiting?
Yes, NCT06549777 is actively recruiting participants. Contact the research team at jorgen.lehmivaara@miun.se for enrollment information.
Where is the NCT06549777 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT06549777 clinical trial?
NCT06549777 is sponsored by Monique Pfaltz. The principal investigator is Monique Pfaltz at +46101428300. The trial plans to enroll 50 participants.