About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
SE-group
BehavioralPsychoeducation and information about treatment possibilities + SE-treatment
Control
BehavioralPsychoeducation and information about treatment possibilities + Phone
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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".
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
Other outcomes
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).
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).
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.
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.
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