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

NCT ID: NCT06549777

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-06
• Study Completion Date: 2026-11-30

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.

Conditions

Safety, Psychological; Acceptability of Health Care; Psychological Safety; Maltreatment, Child; Post Traumatic Stress Disorder; Complex Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SE-group

Intervention Type: BEHAVIORAL

Psychoeducation and information about treatment possibilities + SE-treatment

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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Psychoeducation and information about treatment possibilities + Phone

Interventions

SE-group

Psychoeducation and information about treatment possibilities + SE-treatment

Intervention Type: BEHAVIORAL

Control

Psychoeducation and information about treatment possibilities + Phone

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stockholm University

OTHER

Sponsor Role: collaborator

Monique Pfaltz

OTHER

Sponsor Role: lead

Responsible Party

Monique Pfaltz

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Monique Pfaltz

Role: PRINCIPAL_INVESTIGATOR

+46101428300

Locations

Mid Sweden university and Stockholm university

Stockholm, Stockholm County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Jörgen Lehmivaara

Role: CONTACT

jorgen.lehmivaara@miun.se

+46722477195

Monique Pfaltz

Role: CONTACT

monique.pfaltz@miun.se

+46101428300

Facility Contacts

Jörgen Lehmivaara

Role: primary

jorgen.lehmivaara@miun.se

072-247 71 95

Monique Pfaltz

Role: backup

monique.pfaltz@miun.se

0101428300

References

Anderson SF, Kelley K, Maxwell SE. Sample-Size Planning for More Accurate Statistical Power: A Method Adjusting Sample Effect Sizes for Publication Bias and Uncertainty. Psychol Sci. 2017 Nov;28(11):1547-1562. doi: 10.1177/0956797617723724. Epub 2017 Sep 13.

Reference Type: BACKGROUND

PMID: 28902575 (View on PubMed)

Berman AH, Bergman H, Palmstierna T, Schlyter F. Evaluation of the Drug Use Disorders Identification Test (DUDIT) in criminal justice and detoxification settings and in a Swedish population sample. Eur Addict Res. 2005;11(1):22-31. doi: 10.1159/000081413.

Reference Type: BACKGROUND

PMID: 15608468 (View on PubMed)

Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0.

Reference Type: BACKGROUND

PMID: 12615092 (View on PubMed)

Bergman H, Kallmen H. Alcohol use among Swedes and a psychometric evaluation of the alcohol use disorders identification test. Alcohol Alcohol. 2002 May-Jun;37(3):245-51. doi: 10.1093/alcalc/37.3.245.

Reference Type: BACKGROUND

PMID: 12003912 (View on PubMed)

Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.

Reference Type: BACKGROUND

PMID: 30178492 (View on PubMed)

Cloitre M, Hyland P, Prins A, Shevlin M. The international trauma questionnaire (ITQ) measures reliable and clinically significant treatment-related change in PTSD and complex PTSD. Eur J Psychotraumatol. 2021 Jun 22;12(1):1930961. doi: 10.1080/20008198.2021.1930961.

Reference Type: BACKGROUND

PMID: 34211640 (View on PubMed)

Connor KM, Kobak KA, Churchill LE, Katzelnick D, Davidson JR. Mini-SPIN: A brief screening assessment for generalized social anxiety disorder. Depress Anxiety. 2001;14(2):137-40. doi: 10.1002/da.1055.

Reference Type: BACKGROUND

PMID: 11668666 (View on PubMed)

Ekback M, Benzein E, Lindberg M, Arestedt K. The Swedish version of the multidimensional scale of perceived social support (MSPSS)--a psychometric evaluation study in women with hirsutism and nursing students. Health Qual Life Outcomes. 2013 Oct 10;11:168. doi: 10.1186/1477-7525-11-168.

Reference Type: BACKGROUND

PMID: 24112950 (View on PubMed)

Gerdner A, Allgulander C. Psychometric properties of the Swedish version of the Childhood Trauma Questionnaire-Short Form (CTQ-SF). Nord J Psychiatry. 2009;63(2):160-70. doi: 10.1080/08039480802514366.

Reference Type: BACKGROUND

PMID: 19021077 (View on PubMed)

Gilbert P. Compassion: From Its Evolution to a Psychotherapy. Front Psychol. 2020 Dec 9;11:586161. doi: 10.3389/fpsyg.2020.586161. eCollection 2020.

Reference Type: BACKGROUND

PMID: 33362650 (View on PubMed)

Gillath O, Karantzas G. Attachment security priming: a systematic review. Curr Opin Psychol. 2019 Feb;25:86-95. doi: 10.1016/j.copsyc.2018.03.001. Epub 2018 Mar 15.

Reference Type: BACKGROUND

PMID: 29621693 (View on PubMed)

Heinrichs M, Baumgartner T, Kirschbaum C, Ehlert U. Social support and oxytocin interact to suppress cortisol and subjective responses to psychosocial stress. Biol Psychiatry. 2003 Dec 15;54(12):1389-98. doi: 10.1016/s0006-3223(03)00465-7.

Reference Type: BACKGROUND

PMID: 14675803 (View on PubMed)

Heim N, Bobou M, Tanzer M, Jenkinson PM, Steinert C, Fotopoulou A. Psychological interventions for interoception in mental health disorders: A systematic review of randomized-controlled trials. Psychiatry Clin Neurosci. 2023 Oct;77(10):530-540. doi: 10.1111/pcn.13576. Epub 2023 Aug 9.

Reference Type: BACKGROUND

PMID: 37421414 (View on PubMed)

Isaksson M, Holmbom Goh M, Ramklint M, Wolf-Arehult M. The Social Safeness and Pleasure Scale (SSPS): a psychometric evaluation of the Swedish version in a non-clinical sample and two clinical samples with eating disorders or borderline personality disorder. BMC Psychol. 2022 Dec 16;10(1):311. doi: 10.1186/s40359-022-01020-2.

Reference Type: BACKGROUND

PMID: 36527142 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

Reference Type: BACKGROUND

PMID: 11556941 (View on PubMed)

Kroenke K, Spitzer RL, Williams JB. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002 Mar-Apr;64(2):258-66. doi: 10.1097/00006842-200203000-00008.

Reference Type: BACKGROUND

PMID: 11914441 (View on PubMed)

Kuhfuss M, Maldei T, Hetmanek A, Baumann N. Somatic experiencing - effectiveness and key factors of a body-oriented trauma therapy: a scoping literature review. Eur J Psychotraumatol. 2021 Jul 12;12(1):1929023. doi: 10.1080/20008198.2021.1929023. eCollection 2021.

Reference Type: BACKGROUND

PMID: 34290845 (View on PubMed)

Larsen SE, Fleming CJE, Resick PA. Residual symptoms following empirically supported treatment for PTSD. Psychol Trauma. 2019 Feb;11(2):207-215. doi: 10.1037/tra0000384. Epub 2018 Jul 2.

Reference Type: BACKGROUND

PMID: 29963892 (View on PubMed)

Lewis C, Roberts NP, Gibson S, Bisson JI. Dropout from psychological therapies for post-traumatic stress disorder (PTSD) in adults: systematic review and meta-analysis. Eur J Psychotraumatol. 2020 Mar 9;11(1):1709709. doi: 10.1080/20008198.2019.1709709. eCollection 2020.

Reference Type: BACKGROUND

PMID: 32284816 (View on PubMed)

Luond AM, Wolfensberger L, Wingenbach TSH, Schnyder U, Weilenmann S, Pfaltz MC. Don't get too close to me: depressed and non-depressed survivors of child maltreatment prefer larger comfortable interpersonal distances towards strangers. Eur J Psychotraumatol. 2022 May 30;13(1):2066457. doi: 10.1080/20008198.2022.2066457. eCollection 2022.

Reference Type: BACKGROUND

PMID: 35957629 (View on PubMed)

Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.

Reference Type: BACKGROUND

PMID: 30513087 (View on PubMed)

Mikulincer M, Shaver PR. Attachment theory and intergroup bias: evidence that priming the secure base schema attenuates negative reactions to out-groups. J Pers Soc Psychol. 2001 Jul;81(1):97-115.

Reference Type: BACKGROUND

PMID: 11474729 (View on PubMed)

Morton L, Cogan N, Kolacz J, Calderwood C, Nikolic M, Bacon T, Pathe E, Williams D, Porges SW. A new measure of feeling safe: Developing psychometric properties of the Neuroception of Psychological Safety Scale (NPSS). Psychol Trauma. 2024 May;16(4):701-708. doi: 10.1037/tra0001313. Epub 2022 Jul 18.

Reference Type: BACKGROUND

PMID: 35849369 (View on PubMed)

Payne P, Levine PA, Crane-Godreau MA. Somatic experiencing: using interoception and proprioception as core elements of trauma therapy. Front Psychol. 2015 Feb 4;6:93. doi: 10.3389/fpsyg.2015.00093. eCollection 2015.

Reference Type: BACKGROUND

PMID: 25699005 (View on PubMed)

Pfaltz MC, Passardi S, Auschra B, Fares-Otero NE, Schnyder U, Peyk P. Are you angry at me? Negative interpretations of neutral facial expressions are linked to child maltreatment but not to posttraumatic stress disorder. Eur J Psychotraumatol. 2019 Nov 11;10(1):1682929. doi: 10.1080/20008198.2019.1682929. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31762947 (View on PubMed)

Pfaltz MC, Halligan SL, Haim-Nachum S, Sopp MR, Ahs F, Bachem R, Bartoli E, Belete H, Belete T, Berzengi A, Dukes D, Essadek A, Iqbal N, Jobson L, Langevin R, Levy-Gigi E, Luond AM, Martin-Soelch C, Michael T, Oe M, Olff M, Ceylan D, Raghavan V, Ramakrishnan M, Sar V, Spies G, Wadji DL, Wamser-Nanney R, Fares-Otero NE, Schnyder U, Seedat S. Social Functioning in Individuals Affected by Childhood Maltreatment: Establishing a Research Agenda to Inform Interventions. Psychother Psychosom. 2022;91(4):238-251. doi: 10.1159/000523667. Epub 2022 Apr 5.

Reference Type: BACKGROUND

PMID: 35381589 (View on PubMed)

Rozental A, Kottorp A, Boettcher J, Andersson G, Carlbring P. Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events. PLoS One. 2016 Jun 22;11(6):e0157503. doi: 10.1371/journal.pone.0157503. eCollection 2016.

Reference Type: BACKGROUND

PMID: 27331907 (View on PubMed)

Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Med. 2010 Mar 24;8:18. doi: 10.1186/1741-7015-8-18.

Reference Type: BACKGROUND

PMID: 20334633 (View on PubMed)

Scott JG, Malacova E, Mathews B, Haslam DM, Pacella R, Higgins DJ, Meinck F, Dunne MP, Finkelhor D, Erskine HE, Lawrence DM, Thomas HJ. The association between child maltreatment and mental disorders in the Australian Child Maltreatment Study. Med J Aust. 2023 Apr 3;218 Suppl 6(Suppl 6):S26-S33. doi: 10.5694/mja2.51870.

Reference Type: BACKGROUND

PMID: 37004186 (View on PubMed)

Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

Reference Type: BACKGROUND

PMID: 9881538 (View on PubMed)

Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

Reference Type: BACKGROUND

PMID: 3397865 (View on PubMed)

Other Identifiers

KPB-Study

Identifier Type: -

Identifier Source: org_study_id