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

NCT06549777 | Recruiting

• 1 other identifier: KPB-Study
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Safety, Psychological; Acceptability of Health Care; Psychological Safety; Maltreatment, Child; Post Traumatic Stress Disorder; Complex Post-Traumatic Stress Disorder

Keywords

Safety; Feasibility; Body-oriented intervention; Somatic Experiencing; Psychological safety; Social safeness; Childhood maltreatment; Post traumatic stress disorder; Complex Post traumatic stress disorder; Interoception; Depression

Outcome Measures

Primary Outcomes (1)

• The Neuroception of Psychological Safety Scale (NPSS; Morton et al., 2024)

  To measure psychological safety the 29-item NPSS will be used, which covers social engagement, compassion, and body sensations related to feeling safe. Items on NPSS are scored on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) the extent to which participants agree with the items (e.g., "My body felt relaxed") higher total score indicates higher feelings of psychological safety.

  Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).

Secondary Outcomes (8)

• Social Safeness and Pleasure Scale Scale (SSPS; Gilbert et al., 2009; Isaksson et al, 2022)

  Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).

• International Trauma Questionnaire (ITQ; Cloitre et al., 2018)

  Pre-treatment, during treatment post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).

• The Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001)

  Pre-treatment, during treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).

• The Body Boundaries Survey (BBS; Krzewska & Dolińska- Zygmunt, 2013)

  Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).

• The Multidimensional Assessment of Interoceptive Awareness (MAIA-2; Mehling et al., 2018).

  Pre-treatment, during treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).

Other Outcomes (13)

• Childhood Trauma Questionnaire-Short Form (CTQ-SF; Bernstein et al., 2003; Gerdner & Allgulander, 2009)

  Pre-treatment

• Life event-checklist (LEC-5; Weathers et al., 2013)

  Pre-treatment

• The Mini social phobia inventory (mini-SPIN; Connor et al., 2001)

  Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).

Study Arms (2)

SE-group

EXPERIMENTAL

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.

Behavioral: SE-group

Control

ACTIVE COMPARATOR

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.

Behavioral: Control

Interventions

SE-group BEHAVIORAL

Psychoeducation and information about treatment possibilities + SE-treatment

SE-group

Control BEHAVIORAL

Psychoeducation and information about treatment possibilities + Phone

Control

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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) (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.

You may not qualify if:

• Participants screen positive for alcohol (AUDIT) or substance abuse (DUDIT).
• Psychotic symptoms, ongoing manic episode, acute suicidality.
• Have current (pre-assessment) ongoing psychological treatment focusing on social safeness, PTSD or complex PTSD.

Sponsors & Collaborators

• Monique Pfaltz: lead
• Stockholm University: collaborator

Study Sites (1)

Mid Sweden university and Stockholm university

Stockholm, Stockholm County, Sweden

RECRUITING

Related Publications (31)

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MeSH Terms

Conditions

Patient Acceptance of Health Care; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms

Study Officials

• Monique Pfaltz

  +46101428300

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jörgen Lehmivaara

CONTACT

+46722477195; jorgen.lehmivaara@miun.se

Monique Pfaltz

CONTACT

+46101428300; monique.pfaltz@miun.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to either an intervention group (receiving brief psychoeducation - reading a text which takes approximately 30 min to read - about PTSD/CPTSD, including information about how to seek help/treatment within the Swedish health care system + 15-session body-oriented SE treatment conducted over 20 weeks) or a control group (receiving the same psychoeducation and information about treatment possibilities + regular phone calls during the same period to provide updates on their well-being and if they started a treatment).

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 12, 2024
• Study Start: September 6, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)