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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Sweden
Mid Sweden university and Stockholm university
RECRUITING
Stockholm
Contact Information
Primary
Jörgen Lehmivaara
jorgen.lehmivaara@miun.se
+46722477195
Backup
Monique Pfaltz
monique.pfaltz@miun.se
+46101428300
Time Frame
Start Date: 2024-09-06
Estimated Completion Date: 2026-11
Participants
Target number of participants: 50
Treatments
Experimental: SE-group
The participant allocated to the SE-group will receive the same information sheet (taking approximately 30 minutes to read) as the control group in addition to the SE-treatment (Payne et al., 2010) consisting of 15 sessions conducted by certified SE therapists, with an adapted focus on specifically (C)PTSD and CM, as described in a manual available upon request from the authors. Sessions 1-3 focus on general practices for establishing a sense of self, contacting own space and positive interoceptive experiences. Sessions 4-6 aim to establish self-defensive behavior, to get into contact with one's own strength and with a sense of autonomy and attachment. Sessions 7-9 focus on working with depression, shame and anger. Sessions 10-12 include work with childhood patterns and sessions 13-15 aim at integrating the previous therapeutic work in daily life situations and at recapitulating some of the interventions.
Active_comparator: Control
The control group will receive an information sheet with psychoeducation about (C)PTSD (e.g., advice on self-care for symptom relief, available treatment options) and information about how to seek help/treatment within the Swedish health care system (taking approx.30 minutes to read). During the 20-week period the participant will be free to seek treatment of any kind and will additionally receive three phone calls (10 -15 minutes each time) from a research assistant (supervised by one of the project members). These calls aim to monitor participants' progress in seeking treatment and address any questions or concerns they may have regarding their involvement in the study. In addition, the calls aim to remind participants of completing the study questionnaires, in case they missed completing one or several of them.
Related Therapeutic Areas
Sponsors
Leads: Monique Pfaltz
Collaborators: Stockholm University

This content was sourced from clinicaltrials.gov