Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
NCT Number: NCT06549777
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Safety, Psychological|Acceptability of Health Care|Psychological Safety|Maltreatment, Child|Post Traumatic Stress Disorder|Complex Post-Traumatic Stress Disorder
Interventions: BEHAVIORAL: SE-group|BEHAVIORAL: Control
Sponsor: Monique Pfaltz
Collaborators: Stockholm University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-11

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.

Primary Outcome Measures: 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 Outcome Measures: Social Safeness and Pleasure Scale Scale (SSPS; Gilbert et al., 2009; Isaksson et al, 2022), 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., 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), 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., 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), 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"., 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), 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, 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)., 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., Pre-treatment, during treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).|Experiences in close relationships (ECR-RS; Brennan et al., 1998; Sarling et al., 2021), 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., Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).|The multidimensional scale of perceived social support (MSPSS; Zimet et al., 1988; Ekbäck et al., 2013), 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.")., Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).|The Patient Health Questionnaire-15 (PHQ-15; Korienke et al., 2002), 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., Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).
Other Outcome Measures: Childhood Trauma Questionnaire-Short Form (CTQ-SF; Bernstein et al., 2003; Gerdner & Allgulander, 2009), To measure CM histories, the 28-item CTQ-SF will be used. Participants will indicate on a Likert scale ranging from 1 (Never true) to 5 (Always true) the extent to which they agree with the items (e.g., "I believe I was emotionally abused."). Higher total score indicates more exposure to CM. To be included in the study the participants need to reach cut-off scores categorized as 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)., Pre-treatment|Life event-checklist (LEC-5; Weathers et al., 2013), To assess participant's trauma history, they will be asked to consider their entire lifespan and to indicate which out of 17 traumatic events have happened to themselves or to others (observed by the participant)., Pre-treatment|The Mini social phobia inventory (mini-SPIN; Connor et al., 2001), To measure symptoms of social phobia the 3-item mini-SPIN will be used. Participants will indicate on a 4-point Likert scale (0 = not at all; 4= extremely) the extent to which they agree with items (e.g., " I avoid activities in which I am the center of attention."). Higher scores indicate higher levels of social phobia., Pre-treatment, post-treatment (20 weeks after pre-treatment) and follow-up (20-week after post-treatment).|The Working Alliance Inventory (WAI-S; Horvath, & Greenberg, 1989), To measure the quality of the alliance (between therapist and participant) and study its relationship to treatment outcomes the 12-item WAI-S will be used. Participants and therapist will indicate on a 7-point Likert scale (1= never; 7 = always) the extent to which they agree how often items apply to them (e.g., "My therapist and I work towards common goals.". A higher score indicates a higher degree of working alliance., Post-treatment (20 weeks after pre-treatment)|Vividness and clarity of visualization (Mikulincer & Shaver, 2001), This scale is used exclusively during the experimental study-part.To assess vividness and clarity and emotionally of visualization during guided imagination task (after exposure to insecure and secure attachment primes), participants will rate the vividness and clarity of their visualization and how emotionally it was-on sliding scale ranging from 0 (not at all) to 100 (very much)., Pre-treatment and post-treatment (20 weeks after pre-treatment)|The Swedish version of the types of positive affect scale (TPAS; Gilbert et al., 2008; Lehmivaara et al., 2024, in press), This scale is used exclusively during the experimental study-part. To measure different types of state positive affect related to psychological safety before and after exposure to insecure and secure attachment primes, the 18-item TPAS will be used. Participants will indicate on a Likert scale ranging from 1 (not at all) to 5 (very much) the extent to which they agree with affective states in the present moment: Activated PA (e.g., excitement), Relaxed PA (e.g., calm). and Safe/Content PA (e.g., safe). Higher scores on each subscale indicated higher levels of currently experienced PA., Pre-treatment and post-treatment (20 weeks after pre-treatment)|The Positive and Negative Affect Schedule Short form (PANAS-SF; Garcia,Nima & Lindskär, 2016; Watson, Clark, & Tellegen, 1988), This scale is used exclusively during the experimental study-part. To measure state negative affect before and after exposure to insecure and secure attachment primes, 5 items (affective states, e.g., "upset") from the PANAS-SF will be used. Participants will indicate on a Likert-scale ranging from 1 (very slightly) to 5 (very much) the extent to which they experience with affective states in the present moment (e.g., shame). Higher scores indicate a stronger current negative affective state., Pre-treatment and post-treatment (20 weeks after pre-treatment)|The Subscale Body sensations on the The Neuroception of Psychological Safety (NPSS; Morton et al., 2022), This scale is used exclusively during the experimental study-part. To measure bodily sensations related to perceived safety before and after exposure to insecure and secure attachment primes, the 8-item subscale body sensation from NPSS will be used. Participants will indicate on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree) the extent to which they agree with the items (e.g., "My body feels relaxed.")., Pre-treatment and post-treatment (20 weeks after pre-treatment)|Occurrence of Adverse events on the Negative Effects Questionnaire (NEQ; Rozental et al., 2016), To measure occurrence and characteristics of negative effects (AEs) in psychological treatments the 20-item NEQ will be used. The participants will indicate how they experienced and felt during the treatment with Yes or No to items such as "I felt more stressed" and if yes, they will indicate on 5-point Likert scale to what extent to which it was negative (1 = not at all; 5= extremely) and related to the treatment or not. We will consider a participant to have suicidal ideations if they score Yes on item 10., Post-treatment (20 weeks after pre-treatment assessment)|Feasibility and acceptability of the SE-intervention and psychoeducation on surveys developed for this study, To measure feasibility and acceptability, participants will indicate, how they subjectively experienced and felt during the study (e.g., experience of the intervention/partaking in the study as controls, positive and negative aspects of the treatment, the impact on their wellbeing, and be asked to offer suggestions for improvement), with both yes/no and open questions. Percentage of participants completing SE-treatment and completing outcome measures at the end of treatment and at FU will be calculated as well., Post-treatment (20-weeks after pre-treatment) and Follow-up (20-week after post-treatment).|Alcohol Use Disorders Identification Test (AUDIT; Babor et al., 1989; Bergman & Kaellmen, 2002), To screen for alcohol misuse, we will use the 10 item AUDIT. Participants will indicate on a Likert scale ranging from (1) never to (5) daily on items (e.g., "How often do you drink six or more of such 'glasses' on a single occasion?")., Pre-treatment (before inclusion to the study)|Drug Use Disorders Identification Test (DUDIT; (Berman et al., 2005), To screen for drug misuse, us we will use the 10-item DUDIT. Participant will indicate on a scale ranging from never (1) to 4 times/week or more nearly every day (5) the extent to which they agree with the items (e.g., "How often do you use drugs other than alcohol? (Refer to the drug list on the back.)". If participant score 6 point or above (men) and 2 and above (women) indicate a problem with substance misuse can be present or has been present., Pre-treatment (before inclusion to the study)|Ongoing medication, psychological treatment, and stable dosage, To screen for ongoing medication or psychological treatment and stable dosage both before and during the study, 3 items developed for this study will be used. Participants will indicate with "Yes" or "No" to questions about whether their medication has been ongoing for three months prior to study inclusion, whether the dosage has been stable for at least one month, and whether they are currently undergoing psychological treatment for social safeness, PTSD, or CPTSD. Throughout the study, participants will also be asked regularly if there have been any changes in medication or if they have attended other psychological treatments and be asked to provide open answer to why., Pre-treatment (before inclusion to the study), during, Post-treatment (20-weeks after pre-treatment) and at Follow-up (20-week after post-treatment).