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

Not Applicable

Recruiting

• Conditions: Safety, Psychological; Post Traumatic Stress Disorder; Acceptability of Health Care; Psychological Safety; Maltreatment, Child; Complex Post-Traumatic Stress Disorder
• Interventions: Behavioral: SE-group; Behavioral: Control

• Registration Number: NCT06549777
• Lead Sponsor: Monique Pfaltz

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.

Detailed Description

Adults with a history of CM may struggle with psychological safety on both an emotional and physiological level, such as interpreting neutral facial expressions as negative/threatening or experiencing distress when approaching or being approached by others (Lüönd et al., 2022; Pfaltz et al., 2019). However, just as the social environment can be perceived as threatening, adults with CM-history can also experience absence of safety cues (e.g., perceived social support) which not only heightens the risk of developing and maintaining PTSD and CPTSD (Scott et al., 2023), but also impair social functioning further (cf. Pfaltz et al., 2022).

Although effective interventions like trauma-focused CBT exist for treating mental disorders such as PTSD (Lewis et al., 2020), they less often focus on facilitating feelings related to psychological safety such as social safeness (i.e., the extent to which individuals perceive their world as safe, warm, and soothing). This is problematic because exaggerated stress reactions and somatic symptoms may persist after treatment (Larsen et al., 2019) and social safeness could be a protective factor against these symptoms (Gilbert, 2020). Studies have e.g. shown that the presence of a friend can reduce stress reactions in individuals exposed to social stress (Heinrichs et al., 2003), and exposure to safety-related texts/images can reduce exaggerated stress responses to threatening situations (Gillath \& Karantzas, 2019). Thus, social safeness may be crucial for regulating affective states.

Therefore, it is necessary to evaluate interventions that not only reduce symptoms of mental disorders but also actively focus on facilitating social, emotional, and body sensations related to feeling safe, particularly for individuals with CM-histories that not only suffer from mental disorders, but also lack protective factors that could inhibit it, such as caring support from others or self. One potential intervention is SE, a body-oriented approach (Levine, 1997). Unlike CBT and exposure-based interventions, SE focuses more on interoception and musculoskeletal sensations rather than primary focus on cognitions to promote affective self-regulation and resilience to stress (Payne, 2015). Through SE, clients are assumed to learn to manage unpleasant emotions and reduce negative bodily reactions, while identifying positive bodily sensations that provide safety and calmness. This might help clients to be present in their surroundings and potentially restore their ability to feel socially safe both physically and psychologically.

Preliminary results from our own (to be published) studies show that SE has a short-term effect (one session) on increased perceived psychological safety in adults with a history of CM compared to a control group. Systematic reviews and meta-analyses have as well indicated that SE can reduce symptoms of PTSD, depression, and somatic symptoms (Heim et al., 2023; Kuhfuß et al., 2021). However, there is a research gap concerning the feasibility, acceptability and preliminary long-term effects of SE on facilitating psychological safety in individuals with a history of CM and PTSD/CPTSD symptoms.

Accordingly, we will conduct a pilot RCT, adhering to the Consolidated Standards of Reporting Trials (Schulz, 2010), to evaluate the feasibility of SE, acceptability, and safety as well as to explore the potential of SE (preliminary outcomes) for improving social functioning and mental health for adult participants with a CM-history and symptoms of (C)PTSD. Participants meeting these criteria will be randomly allocated to either an SE-group (n=25) or to a control group (n=25). Self-report measures will be collected pre, post-treatment, and at a 20-week FU assessing primary outcomes (Psychological Safety) and secondary outcomes (Social Safeness, PTSD, CPTSD, Depression, Sense of Disrupted Body Boundaries, Interoceptive Awareness, Attachment style, Social Support, and Somatic symptoms). Potential influencing variables (Socio-Demographics, Attitudes towards Psychotherapy, CM history, Attachment style, Interoceptive Awareness, Social Phobia, and Therapeutic Alliance) will be analyzed to explore potential mechanisms of treatment responses in primary and secondary outcomes. Moreover, participants will attend a physical visit (experimental study part) at Stockholm University (SU) where we assess behavioral (e.g., interpersonal distance), physiological responses (HR, HRV and EDA) and affective responses (e.g., negative affect) to social stimuli (e.g., facial expressions).

In addition to primarily assessing safety, feasibility and acceptability of the intervention (See brief summary), we will test the following hypotheses regarding preliminary effects of the intervention:

Primary hypothesis (Primary outcomes):

1. Participants in the SE-group, compared to the control group, will show higher levels of Psychological Safety at post-treatment and FU.

Secondary hypothesis (Secondary outcomes):

2. Participants in the SE-group, compared to the control group, will show higher levels of Social Safeness at post-treatment and FU.

3. Participants in the SE-group, compared to the control group, will show lower levels of PTSD, CPTSD, Depression, Sense of Disrupted Body Boundaries and Somatic Symptoms at post-treatment and FU.

4. Participants in the SE-group, compared to the control group, will show higher levels of Attachment Security, Interoceptive Awareness, and Social Support at post-treatment and FU. 5. Based on preliminary results from our short-term intervention study, higher levels of CM will predict a stronger treatment response, indicated by a stronger increase in Psychological Safety in the SE-group compared to the control group.

Hypotheses related to the experimental study part:

6. Participants in the SE-group, compared to the control group, will rate neutral facial expressions less negatively from pre- to post-treatment.

7. Participants in the SE-group, compared to the control group, will show greater decrease in preferred interpersonal distance from pre- to post-treatment.

8. Participants in the SE-group, compared to the control group, will show improved affective/physiological self-regulation (self-reports on TPAS, body sensations, higher HRV, lower HR, and decreased EDA response) following exposure to attachment primes (recalling and visualization interpersonal insecure and secure attachment-related experiences) from pre- to post-treatment.

Method

To characterize the sample (presence of mental disorders) and to assess exclusion criteria we will employ sections of the MINI (Sheehan et al., 1998) that is relevant for our study population.

Before randomization, participants will complete four experimental paradigms at SU, including: "stop-distance task," (measuring participants' preferred physical distance towards strangers, see Lüönd et al., 2022) and a "rope exercise" measuring safety within one's personal space (for exploratory purposes). Then, the participants' physiological (HR, HRV, EDA) and self-reported responses to facial expressions (Pfaltz et al., 2019) will be assessed. Lastly, the participants' affective (self-reported) and physiological (HR, HRV, EDA) self-regulation in response to attachment primes (described above) will be evaluated. After the physical visit, randomization to SE or control will take place.

Adverse events (AEs) will be defined as any unfavorable medical occurrences or undesirable experiences (e.g., suicidal thoughts, dependency, symptom worsening, hopelessness, failure, stigma, quality of treatment) encountered by participants during the study-period, regardless of their relation to the study.

All participants will complete symptom scales (ITQ and PHQ9) at pre, repeatedly during, post and at FU. A symptom increases on ITQ from pre to any of the follow-up measurement points of 50% - 79% is considered an AE, an increase of 80% or more is considered a SAE. If participants score ≥ 1 on suicidality item 9 (PHQ-9) at any of the measurement points, we will conduct a risk assessment and based on this determine if one of the following applies: (i) death by suicide; (ii) suicide attempt; (iii) suicidal crisis without attempt; (iv) self-harming behaviors and thoughts of self-harm.

(i) - (iv) are counted as SAE if they:

1. result in death and/or:

2. are life-threatening

3. require hospitalization or prolongation of existing hospitalization

4. result in significant disability or incapacity Thoughts and behaviors that do not result in a), b), c), or d) will be considered AE.

Determination of whether an (S)AEs is related to the SE-treatment will be based on whether the event is unexpected or unexplained given participants' clinical development, previous medical conditions, medications or interventions. An AE form will be provided to therapists for completion at the end of each session, instructed to report AEs within 24 hours and SAEs directly to the research team, who will review (and consult with a psychiatrist in the project) and assess the nature of each event(s) to decide on appropriate actions such as potential participant withdrawal of the study.

At post-treatment, AEs will be assessed using the NEQ. Feasibility and acceptability will be evaluated via participant-written evaluations, analyzed both quantitatively (e.g., percent of satisfactory with SE and recommend SE to others) and qualitatively (e.g., thematic analysis). All SE sessions will be audio-recorded for exploratory analysis and to assess treatment integrity and fidelity. A random selection of sessions will be independently scored, by an independent assessor, for fidelity to ensure adherence to the treatment manual.

There are no efficacy studies on longitudinal interventions for Psychological Safety, to enable adequate a priori power calculations and resource constraints allowing for a sample size (approximately n=25 in each group), our study will follow Lakens (2022) recommendations: assessing precision via confidence interval widths and explore detectable effect sizes across various power levels via sensitivity power analysis. Based on the outcome, the BUCSS R package (See Anderson et al., 2017) for implementing Bias- and Uncertainty-Corrected Sample Size, a method of correcting for publication bias and uncertainty when planning sample sizes in a future study from an original study.

Analyses will follow an intention-to-treat approach, including all randomized participants, even those who do not complete the study. For primary and secondary outcomes, we plan to use linear mixed models to handle missing data, assuming data are missing at random. Time (pre, post, treatment, and FU) and Group (SE vs. control) will be fixed effects, with participants as random effects. Treatment efficacy will be indicated by a significant time-by-treatment interaction. Potential moderators influencing treatment effects will be analyzed as covariates in the mixed model analysis. Clinically significant changes in (C)PTSD and Depression scores will be analyzed by calculating a Reliable Change Index (RCI), classified as "improved," "worsened," or "unchanged" based on changes in symptom scores exceeding relevant RCI values (See Cloitre et al. 2021). Behavioral and physiological responses at the experimental study part will be analyzed using a similar analytic approach (linear mixed models) or ANOVA. HRV measurement will include both common frequency estimates (e.g., HF) and time domain estimates (e.g., rMSSD).

Outliers will be identified using univariate and multivariate detection methods, such as Cook's distance (with values \>1 indicating an outlier) and standardized residuals (±3.29 indicating an outlier, Tabachnick \& Fidell, 2013). If outliers are identified, we aim to present results both with outliers, and with the adjustment for outliers, and/or consider using robust maximum likelihood (MLR) estimation, which is more robust against outliers.

Study Timeline

• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Study Start: 2024-09-06
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-14
• Primary Completion: 2026-11
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion 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 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SE-group	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
The Neuroception of Psychological Safety Scale (NPSS; Morton et al., 2024)	Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).	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.

Secondary Outcome Measures

Name	Time	Method
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).	To measure PTSD and CPTSD the 18-item ITQ will be used. Participants will indicate on a Likert scale ranging from 0 (Not at all) to 4 (Extremely) the extent to which they agree with the items (e.g., "Having upsetting dreams that replay part of the experience or are clearly related to the experience?"). Probable PTSD is considered when at least one symptom from all PTSD symptom clusters and at least one PTSD-related functional impairment has a score ≥2. Probable complex PTSD is confirmed if all PTSD criteria are met, and at least one symptom in each DSO cluster (Disorders in self-organization) and at least one DSO-related functional impairment are ≥2.A symptom increases on ITQ from pre to any of the follow-up measurement points of 50% - 79% is considered an AE, an increase of 80% or more is considered a SAE.
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 PHQ-9 (Korienke et al., 2001) is a 9-item questionnaire measuring depressive symptoms and suicidal ideations. Participants will indicate on a Likert scale ranging from several days (0) to nearly every day (3) the extent to which they agree with the items (e.g., "Little interest or pleasure in doing things."). High scores indicate a higher frequency of depressive symptoms over the past two weeks. We will consider a participant to have suicidal ideations if they score 1 or \> on item 9 "Thoughts that you would be better off dead or of hurting yourself in someway".
Experiences in close relationships (ECR-RS; Brennan et al., 1998; Sarling et al., 2021)	Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).	To measure adult attachment style, the 9-item ECR-12 will be used. Participants will indicate on a Likert scale ranging from 1 (Strongly disagree) to 7 (strongly agree) the extent to which they agree with the items (e.g., "I worry about being abandoned by the person closest to me."). Low scores indicate a perceived secure attachment, and high scores indicate a perceived insecure attachment.
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).	To measure Social Safeness (a state related to feeling psychological safe) the 11- item SPSS will be used. Items are scored on a Likert scale ranging from 1 (almost never) to 5 (almost all the time) to measure the extent to which participants agree with the items (e.g., "I feel easily soothed by those around me."). Scores are added together to produce a total score in the range 11-55, with higher scores representing higher perceived social safeness.
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).	To measure sense of disrupted body boundaries the 17 item BBS will be used. Participants will indicate on a Likert-scale ranging from 1 (Definitely don't agree) to 5 (Strongly agree) the extent to which they agree with items (e.g., "When someone gets too close to me, I feel as if he/she is invading my physical space."). Higher scores indicated a stronger sense of disrupted body boundaries
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).	To measure interoceptive awareness three subscales (Self-Regulation, Noticing, Trusting and Emotional awareness), i.e., 16-items from the MAIA-2 will be used (based on results from our unpublished study). Participants will indicate on a Likert scale ranging from 1 (Never) to 5 (Always) the extent to which they agree with each item (e.g., "I can return awareness to my body if I am distracted."). Higher scores indicate stronger interoceptive awareness.
The multidimensional scale of perceived social support (MSPSS; Zimet et al., 1988; Ekbäck et al., 2013)	Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).	To measure perceived social support the 12-item MSPSS will be used. Participants will indicate on a Likert scale ranging from 1 (very strongly disagree) to 7 (very strongly agree) the extent to which they agree with each item (e.g., "I get the emotional help and support I need from my family.").
The Patient Health Questionnaire-15 (PHQ-15; Korienke et al., 2002)	Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).	To measure somatic symptoms the 15 item PHQ-15 will be used. Participants will indicate on a Likert-scale ranging from 1 (not bothered at all) to 3 (bothered a lot)" to the extend they have been bothered by symptoms during the past four weeks (e.g., "Stomach pain."). Total scores range from 0-30 (for women), 0-28 (men), with scores of ≥5, ≥10, ≥15 representing mild, moderate and severe levels of somatization.

Trial Locations

Locations (1)

Mid Sweden university and Stockholm university; 🇸🇪 Stockholm, Stockholm County, Sweden