Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549777
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n25 psychoeducation and information about treatment possibilities 15-session SE treatment or to a control group n25 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 eg achieving the target sample goal assessing attrition rates and session attendance and the acceptance of the used SE intervention eg 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 eg interoception that could contribute to decreased mental health and social functioning issues Additionally participants behavioral eg interpersonal distance and physiological responses HR HRV EDA to social stimuli will be assessed pre- and post-treatment in an experimental setup to explore SEs potential to reduce Negative Affect and increase Positive Affect Activated Relaxed SafeContent 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 negativethreatening 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 eg 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 ie 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 eg 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 textsimages 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 PTSDCPTSD 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 CPTSD Participants meeting these criteria will be randomly allocated to either an SE-group n25 or to a control group n25 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 eg interpersonal distance physiological responses HR HRV and EDA and affective responses eg negative affect to social stimuli eg 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 affectivephysiological 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 ones 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 eg 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 andor
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 SAEs 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 events 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 eg percent of satisfactory with SE and recommend SE to others and qualitatively eg 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 n25 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 CPTSD 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 eg HF and time domain estimates eg rMSSD
Outliers will be identified using univariate and multivariate detection methods such as Cooks distance with values 1 indicating an outlier and standardized residuals 329 indicating an outlier Tabachnick Fidell 2013 If outliers are identified we aim to present results both with outliers and with the adjustment for outliers andor consider using robust maximum likelihood MLR estimation which is more robust against outliers
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 ie 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 eg 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 textsimages 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 PTSDCPTSD 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 CPTSD Participants meeting these criteria will be randomly allocated to either an SE-group n25 or to a control group n25 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 eg interpersonal distance physiological responses HR HRV and EDA and affective responses eg negative affect to social stimuli eg 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 affectivephysiological 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 ones 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 eg 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 andor
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 SAEs 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 events 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 eg percent of satisfactory with SE and recommend SE to others and qualitatively eg 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 n25 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 CPTSD 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 eg HF and time domain estimates eg rMSSD
Outliers will be identified using univariate and multivariate detection methods such as Cooks distance with values 1 indicating an outlier and standardized residuals 329 indicating an outlier Tabachnick Fidell 2013 If outliers are identified we aim to present results both with outliers and with the adjustment for outliers andor consider using robust maximum likelihood MLR estimation which is more robust against outliers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None