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临床试验/NCT06549777
NCT06549777招募中不适用

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

Monique Pfaltz1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
The Neuroception of Psychological Safety Scale (NPSS; Morton et al., 2024)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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).)
  • 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).)
  • 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).)
  • 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).)
  • 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).)
  • 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).)

研究者

发起方
Monique Pfaltz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Monique Pfaltz

Professor

Mid Sweden University

研究点 (1)

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