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New treatment option for Safety, Psychological
Official title Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
ClinicalTrials.gov ID: NCT06549777
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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)...
- Meeting at least moderate/severe PTSD or complex PTSD symptoms on the ITQ.
You likely can't join if
- 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...
- Have current (pre-assessment) ongoing psychological treatment focusing on social safeness, PTSD or complex PTSD.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Stockholm, Stockholm County, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stockholm, Stockholm County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.