RecruitingNot ApplicableNCT06549777

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

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


Sponsor

Monique Pfaltz

Enrollment

50 participants

Start Date

Sep 6, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an online body-oriented psychotherapy program for adults in Sweden who experienced childhood maltreatment (such as emotional, physical, or sexual abuse or neglect) and are currently dealing with trauma-related symptoms, including PTSD or complex PTSD. Body-oriented therapy focuses on the connection between physical sensations and emotional experiences as a way to process trauma. **You may be eligible if...** - You are an adult (18 years or older) - You are proficient in Swedish - You have access to a computer and the internet - You meet the threshold for childhood maltreatment based on a standard questionnaire - You have at least moderate to severe PTSD or complex PTSD symptoms - If on medication, your dosage has been stable for at least 1 month **You may NOT be eligible if...** - You have a current serious alcohol or substance abuse problem - You are experiencing psychosis, a manic episode, or are at acute risk of suicide - You have a serious physical condition that prevents participation - You are currently in another psychological treatment program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALSE-group

Psychoeducation and information about treatment possibilities + SE-treatment

BEHAVIORALControl

Psychoeducation and information about treatment possibilities + Phone


Locations(1)

Mid Sweden university and Stockholm university

Stockholm, Stockholm County, Sweden

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NCT06549777


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