Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
ID06549777

Body-oriented Psychotherapy vs. Psychoeducation and Treatment Information for Individuals With a History of Child Maltreatment and Trauma-related Symptoms: Assessing Safety, Feasibility, Acceptability, and Preliminary Outcomes

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

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Monique Pfaltz

Lead Sponsor

S

Stockholm University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research investigates the safety, feasibility, acceptability, and early effects of a body-oriented psychotherapy called Somatic Experiencing (SE) on social functioning and mental health. It focuses on adults with a history of child maltreatment who have symptoms of posttraumatic stress disorder (PTSD) or complex PTSD (CPTSD). The study aims to explore how SE might improve psychological safety, social safeness, and reduce symptoms related to trauma, depression, and body awareness issues. Participants will be randomly assigned to one of two groups: an SE group or a control group. The SE group receives psychoeducation plus 15 sessions of SE therapy conducted by certified therapists, focusing on trauma and related symptoms. The control group receives psychoeducation and information about treatment options along with regular phone calls for updates and support. The study includes pre-treatment, post-treatment (20 weeks after starting), and follow-up assessments 20 weeks after treatment ends. Participants will complete self-report questionnaires and take part in experimental tasks measuring behavioral and physiological responses to social stimuli, such as facial expressions and interpersonal distance. Researchers will assess psychological safety as the primary outcome, along with social safeness, PTSD symptoms, depression, and other factors. Safety monitoring includes tracking adverse events and serious adverse events throughout the study. Participants’ experiences and treatment adherence will be evaluated, and results will inform future research directions.

CONDITIONS

Brief 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 specific questionnaire cutoffs
  • Moderate to severe PTSD or complex PTSD symptoms
  • Stable medication dose for at least 1 month if on medication
  • Signed informed consent provided
Not Eligible

You will not qualify if you...

  • Positive screen for alcohol or substance abuse
  • Presence of psychotic symptoms, ongoing manic episode, or acute suicidality
  • Current psychological treatment focusing on social safeness, PTSD, or complex PTSD
  • Physiological data affected by medication will be excluded from analysis but treatment is allowed

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at Stockholm University for experimental assessments including behavioral, physiological, and affective responses to social stimuli.

Treatment

Duration - Approximately 20 weeks

Participants receive either 15 sessions of Somatic Experiencing (SE) therapy focusing on psychological safety and trauma symptoms, or psychoeducation with treatment information plus three phone calls during the 20-week period.

15 in-person SE therapy sessions or 3 phone calls for control group during the treatment period

Follow-up

Duration - 20 weeks after treatment completion

Participants complete self-report measures assessing psychological safety, social safeness, PTSD, depression, somatic symptoms, and other outcomes 20 weeks after treatment ends.

Self-report questionnaires completed remotely

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

M

Monique Pfaltz

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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