Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT06549777

Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms

Led by Monique Pfaltz · Updated on 2024-10-15

50

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

Sponsors

M

Monique Pfaltz

Lead Sponsor

S

Stockholm University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Proficient in Swedish language
  • Access to a computer and internet
  • History of child maltreatment meeting CTQ cutoff scores
  • Moderate to severe PTSD or complex PTSD symptoms on the ITQ
  • Medication use stable for at least 1 month if applicable
  • Signed informed consent provided
Not Eligible

You will not qualify if you...

  • Positive screen for alcohol or substance abuse
  • Psychotic symptoms, ongoing manic episode, or acute suicidality
  • Current medication impacting physiological data during social testing
  • Currently receiving psychological treatment focused on social safeness, PTSD, or complex PTSD

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mid Sweden university and Stockholm university

Stockholm, Stockholm County, Sweden

Actively Recruiting

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Research Team

J

Jörgen Lehmivaara

CONTACT

M

Monique Pfaltz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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