PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy (COMPATi)

COMPATi: A Randomized Controlled Trial on the Efficacy of the PSYCHOPATHY.COMP Program Among Male Prison Inmates With Psychopathy

The goal of this clinical trial is to learn whether PSYCHOPATHY.COMP, an individual compassion-focused, therapy-based intervention of 20 weekly sessions, can reduce psychopathy in prison inmates. Psychopathy is linked with the most severe and persistent forms of antisocial behavior. This trial will also learn whether the program improves emotional and behavioral regulation.

The main questions are:

• Does PSYCHOPATHY.COMP reduce psychopathy?
• Does PSYCHOPATHY.COMP improve emotional and behavioral regulation? Researchers will compare PSYCHOPATHY.COMP with the usual individual case management support provided in prisons.

Portuguese-speaking adult male prison inmates will be invited to participate. Those who consent to participate will be screened for inclusion (T0). A total of 200 eligible participants will take part. All participants will be invited to complete a baseline assessment (T1, pre-treatment assessment), after which they will be randomly assigned to receive PSYCHOPATHY.COMP or the usual care provided in the prison for a period of around six months. All participants will be invited to complete a post-treatment assessment (T2) and a six-month follow-up assessment post-treatment. Assessments will collect data on sociodemographic characteristics and legal/criminal information, psychological outcomes (psychopathy, emotional regulation, and behavioral regulation), psychological mediators (mechanisms of change: compassion-related variables), and moderators (personality pathology), and data on social desirability.

This study aims to contribute to advancing scientific knowledge about whether and how to reduce psychopathy among prison inmates and have an impact on clinical practice and society by making available evidence-based interventions to this at-risk/high-risk population.

Study Overview

• Status: Not yet recruiting
• Conditions: Antisocial Personality Disorder (ASPD)
• Intervention / Treatment: Behavioral: PSYCHOPATHY.COMP; Other: Treatment as Usual (TAU)

Detailed Description

There has long been interest in the study of psychopathy, defined as a set of interpersonal (e.g., grandiosity, manipulation), affective (e.g., callousness, unemotionality), deviant lifestyle (e.g., impulsivity, irresponsibility), and antisocial traits (e.g., criminal versatility). Psychopathy is usually associated with the most severe and persistent forms of antisocial behavior, being a strong predictor of violent behavior and overall criminal recidivism. Given that inmates with psychopathy represent 15-40% of the in-prison population (depending on the risk level of the sample and type of crime), delivering evidence-based interventions specifically tailored to their needs, mitigating the clinical and societal costs of psychopathy and antisocial behavior, is of utmost relevance.

To our knowledge, the PSYCHOPATHY.COMP is the first program specifically designed to reduce psychopathy and antisocial behavior through the promotion of a compassionate motivation. PSYCHOPATHY.COMP consists of a structured, individual, 20-session therapy-based intervention based on Compassion Focused Therapy (CFT). Results from a (nonrandomized) controlled clinical trial showed that the PSYCHOPATHY.COMP is an effective treatment for reducing psychopathic traits and disruptive behavior in detained youth, as well as for promoting compassionate motivation and emotion regulation (medium/large effect sizes), with compassionate motivation having a significant mediating effect on the changeability of psychopathic traits. Results showed treatment effects were sustained for up to six months after the intervention. Despite these findings, it is unknown whether prison inmates with psychopathy can benefit from this program, as they are considered more resistant to treatment than their youth counterparts. This project aims to test the efficacy of the PSYCHOPATHY.COMP in reducing psychopathic traits, as well as in promoting emotion and behavior regulation among male adults (19-30 years; developmentally closer age range of detained youth) prison inmates through the promotion of a compassionate motivation.

COMPATi aims to test the efficacy of the PSYCHOPATHY.COMP among adult male prison inmates with antisocial personality disorder (ASPD) and high levels of psychopathic traits. Specifically, it aims to:

PRIMARY GOALS:

1. Test the efficacy of the PSYCHOPATHY.COMP in reducing psychopathic traits (primary outcome) when compared with Treatment as Usual (TAU) within one month after the treatment completion, and assess the stability of change up to six months after treatment,

   SECONDARY GOALS:

2. Test the efficacy of the PSYCHOPATHY.COMP in promoting emotion and behavior regulation (secondary outcomes) when compared with TAU within one month after the treatment completion, and assess the stability of change up to six months after treatment,
3. Assess the mediating role of change in compassion-related variables on the efficacy of the PSYCHOPATHY.COMP,
4. Assess the moderating effect of personality pathology on the efficacy of the PSYCHOPATHY.COMP.

This is a pre-registered, multi-center, two-arm, parallel, blinded (by data analysts), randomized controlled trial (RCT) with 1:1 computer-generated, blocked randomized allocation to treatment (allocated to receive PSYCHOPATHY.COMP) or control (allocated to receive the treatment as usual - TAU) groups. A total of 200 Portuguese-speaking adult male prison inmates are estimated to be recruited from 10 randomly selected high-security male prisons in Portugal, for a total of 19 prisons. Male prison inmates are consecutively screened for inclusion (T0). Those who consent to participate and meet the inclusion criteria are invited to complete the baseline T1 assessment. After the T1 assessment, participants are randomly allocated to the treatment or control groups. PSYCHOPATHY.COMP is delivered by psychologists (including those from prisons) for about 6 months. Treatment integrity will be ensured by following established recommendations: psychologists will be trained (through an intensive, face-to-face 5-day training) and supervised (one session per month) during the delivery of the intervention (training/supervision is carried out by the research team members); therapists and participants will rate every session on their subjective perception regarding the usefulness of the session and the therapeutic relationship (therapist will also rate every session on their subjective perception regarding how they follow the manualized protocol of the session and their overall rating of the sessions); as sessions cannot be audio- or video-recorded for ethical reasons, CFT experts from the research team will observe and rate 20% of the sessions using a measure of treatment integrity for the CFT approach. All participants are then invited to complete an assessment within one month after treatment (T2) and a follow-up assessment at 6 months post-treatment (T3). Assessments will collect sociodemographic and legal/criminal data (at T1), data on psychological mediators (compassion-related variables; at T1-T3), and outcomes. In this latter, psychopathy (primary outcome) will be assessed at T0-T3, emotional regulation (secondary outcome) at T1-T3, and behavioral regulation (secondary outcome) will be observed over time, covering the period from T0 to T3. Social desirability will also be controlled for and assessed at T1-T3. The evaluation of personality pathology (psychological moderator) will be conducted at eligibility (T0, for ASPD) and at baseline (T1, for other personality disorders) using a structured clinical interview. All assessments rely on self-report and observable data (collected from prison record files) and are conducted by the research team.

A priori power analyses estimate that a minimum of 171 participants is necessary to detect medium effects (significance level of .05, power of .90). Accounting for participation and attrition rates, a minimum of 200 individuals need to be recruited.

Results aim to provide foundational knowledge of PSYCHOPATHY.COMP's efficacy among prison inmates. Results will inform the potential benefits and implementation of PSYCHOPATHY.COMP in prison settings in Portugal and its potential translation to other countries, helping to answer the clinical and societal need to make available evidence-based interventions to this at-risk/high-risk population.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Lisbon, Portugal
    • Prisons of the Direção-Geral de Reinserção e Serviços Prisionais (DGRSP)
    • Contact: Ana Cristina Sabino Pestana Neves Subdirector of the DGRSP Organisational Unit, PhD; Phone Number: 351 + 218812200; Email: ananeves@egasmoniz.edu.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• male prison inmates,
• Portuguese-speaking,
• aged between 19 and 30 years
• having at least one prior case in the juvenile justice system in which a judicial measure was applied,
• with high levels of psychopathic traits (measured with the SRP-SF and LSRPS self-reported questionnaires)
• with an Antisocial Personality Disorder (ASPD) diagnosis (measured with the SCID-II)

Exclusion criteria:

• suspected psychotic/autism spectrum disorders and/or cognitive impairments,
• female,
• sentence length inferior to 24 months since the start of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; PSYCHOPATHY.COMP	Behavioral: PSYCHOPATHY.COMP; Participants allocated to the treatment group will receive PSYCHOPATHY.COMP. PSYCHOPATHY.COMP is a manualized intervention of 20 weekly 60-min sessions (~6 months) rooted in Compassion Focused Therapy (CFT). PSYCHOPATHY.COMP follows a progressive strategy of change in four modules: (1) The basics of our mind; (2) Our mind according to CFT; (3) Compassionate Mind Training; and (4) Recovery, relapse and prevention. As a common feature of all therapeutic sessions, therapists are focused on developing a secure therapeutic relationship. PSYCHOPATHY.COMP is delivered by psychologists skilled in CFT (including those from prisons). Psychologists will be trained (through an intensive, face-to-face 5-day training) and supervised (one session/month) by the research team during the delivery of the intervention. During PSYCHOPATHY.COMP, participants will not receive individual therapy (psychotherapy, psychological treatment) by an accredited psychologist or therapist.; Other Names: Treatment group
Active Comparator: Control; Treatment as Usual (TAU)	Other: Treatment as Usual (TAU); Participants in the control group will receive the routine support offered in the prison setting, tailored to individual case management and focused on behavioural management and adjustment.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Testing: change from eligibility assessment in participant-reported psychopathy (primary outcome) to six-month follow-up	Modified intention-to-treat (mITT, all participants randomized) and per protocol (PP, only participants who completed a sufficient dose) analyses of mean differences in participant-reported psychopathy between PSYCHOPATHY.COMP and TAU groups. Measured with the Self-Report Psychopathy Scale - Short-form (SRP-SF): a 29-item, shortened version of SRP-4 that assesses psychopathy according to the conceptualization of the Hare's Psychopathy Checklist - Revised. SRP-SF measures four facets of psychopathy: interpersonal (INT; 7 items), affective (AFF; 7 items), lifestyle (LIF; 7 items), and antisocial (ANT; 8 items). Items are rated on a five-point Likert-type scale, ranging from 1: "Strongly disagree" to 5: "Strongly agree". Total and subscale scores are computed by summing the corresponding individual item scores (after correcting for reversed items), with higher scores indicating higher levels of psychopathic traits.	From eligibility to six months after the end of treatment. Measured at eligibility (T0), baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment
Efficacy Testing: change from eligibility assessment in participant-reported psychopathy (primary outcome) to six-month follow-up	mITT and PP analyses of mean differences in participant-reported psychopathy between PSYCHOPATHY.COMP and TAU groups. Measured with the Levenson Self-Report Psychopathy Scale (LSRPS): a 26-item questionnaire assessing psychopathy in two domains: primary (selfish, callous, uncaring and manipulative; 16 items) and secondary (impulsivity and behavioural control; 10 items) psychopathy, which aligns with the conceptualization of the Hare's Psychopathy Checklist - Revised. Items are rated on a four-point Likert-type scale, ranging from 1: "Strongly disagree" to 4: "Strongly agree". Total and subscale scores are computed by summing the corresponding individual item scores (after correcting for reversed items), with higher scores indicating higher levels of psychopathy.	From eligibility to six months after the end of treatment. Measured at eligibility (T0), baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Testing: changes from baseline in participant-reported emotional regulation (secondary outcome) to six-month follow-up	mITT and PP analyses of mean differences in emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with State-Trait Anger Expression Inventory (STAXI): 44-item self-report questionnaire assessing anger-state (how one feels in the present moment; 10 items), anger-trait (how one generally feels, 10 items; with two factors: temperament and angry reaction, 4 items each), and anger-expression (how one generally reacts or behaves when feeling enraged or angry, 24 items; three factors: anger expression-in, anger expression-out and anger control, 8 items each). Items are rated on a four-point Likert-type scale from 1: "Not at all/almost never" to 4: "Very much so/almost always". Scale scores are computed by summing item scores, higher scores indicate higher levels of anger. Anger Expression scale is calculated as the sum of Anger Expression-In and Anger Expression-Out minus Anger Control, plus a constant.	From baseline to six months after the end of treatment. Measured at baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment
Efficacy Testing: changes from baseline in participant-reported emotional regulation (secondary outcome) to six-month follow-up	mITT and PP analyses of mean differences in participant-reported emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with the Other As Shamer Scale - 2 (OAS-2), a shorter form of the Other as Shamer scale (OAS). OAS-2 is an 8-item self-report questionnaire measuring external shame (i.e., subject's perception of being negatively judged by others). Items are rated on a five-point Likert-type scale, ranging from 0: "Never" to 4: "Almost always". The scale scores are computed by summing the corresponding individual item scores, with higher scores indicating higher levels of shame.	From baseline to six months after the end of treatment. Measured at baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment
Efficacy Testing: changes from eligibility in participant-reported behavioral regulation (secondary outcome) to six-month follow-up	mITT and PP analyses of mean differences in participant-reported behavioral regulation between PSYCHOPATHY.COMP and TAU groups. Measured with an institutional behavioral grid (IBG) developed by the research team and previously used. IBG assessed the number/type of disciplinary infractions and the number of days of the punitive measures applied by the prison administration (collected from individual prison record files).	From eligibility to six months after the end of treatment: from eligibility to baseline (T0-T1, pre-treatment), baseline to within one-month after treatment (T1-T2, during treatment), within one-month to six months after treatment (T2-T3, post-treatment)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mediation Testing: participant-reported compassion-related variables	mITT and PP analyses of mean differences in participant-reported emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with the Self-Compassion Scale (SCS): a 26-item self-report questionnaire measuring six components (subscales) of self-compassion: self-kindness (5 items), self-judgment (5 items), common humanity (4 items), isolation (4 items), mindfulness (4 items), and overidentification (4 items). Items are rated on a five-point Likert-type scale, ranging from 1: "Almost never" to 5: "Almost always". Scores are computed by averaging item responses (after correcting for reversed items), with higher scores indicating higher levels of self-compassion.	From baseline to six months after the end of treatment. Measured at baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment
Mediation Testing: participant-reported compassion-related variables	mITT and PP analyses of mean differences in participant-reported emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with the Compassion Scale (CS): a 16-item self-report questionnaire measuring compassion towards others, composed of subscales representing kindness (4 items), common humanity (4 items), mindfulness (4 items), and indifference (4 items). Items are rated on a five-point Likert-type scale, ranging from 1: "Almost never" to 5: "Almost always". Scores are computed by averaging item responses (after correcting for reversed items), with higher scores indicating higher levels of compassion for others.	From baseline to six months after the end of treatment. Measured at baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment
Mediation Testing: participant-reported compassion-related variables	mITT and PP analyses of mean differences in participant-reported emotional regulation between PSYCHOPATHY.COMP and TAU groups. Measured with the Fears of Compassion Scales (FCS): a 38-item self-report questionnaire that comprises three scales measuring: Fears of expressing compassion for others (10 items); Fears of receiving compassion from others (13 items), and Fears of compassion for self (15 items). Items are rated on a five-point Likert-type scale from 0 "Don't agree at all" to 4: "Completely agree". Scores are computed by averaging item responses, with higher scores indicating greater fears of compassion in the respective dimension.	From baseline to six months after the end of treatment. Measured at baseline assessment (T1, pre-treatment), within one month after the end of treatment (T2, post-treatment), and six months (T3, follow-up) after the end of treatment
Moderation Testing: participant-reported personality pathology pre-treatment	mITT and PP analyses of mean differences in personality pathology between PSYCHOPATHY.COMP and TAU groups. Measured with the Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II): a semi-structured diagnostic interview assessing Axis II personality disorders from the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), and the depressive and passive-aggressive personality disorders (included in DSM-IV's appendix). It can be used to diagnose personality disorders categorically (present/absent) and dimensionally (according to the number of criteria met for each diagnosis) and is considered the "gold standard" for Personality Disorders diagnosis. The SCID-II also provides a summary with a pathology profile of scores over the assessed Personality Disorders.	Antisocial Personality Disorder (ASPD) measured at eligibility (T0, pre-treatment) and the other personality diagnosis at baseline assessment (T1, pre-treatment)

Collaborators and Investigators

• Sponsor: University of Coimbra
• Collaborators: European Regional Development Fund; Portuguese National Funding Agency for Science, Research and Technology (FCT)

Publications and helpful links

General Publications

• Pommier E, Neff KD, Toth-Kiraly I. The Development and Validation of the Compassion Scale. Assessment. 2020 Jan;27(1):21-39. doi: 10.1177/1073191119874108. Epub 2019 Sep 13.
• First, M. B., Gibbon, M., Spitzer, R. L., Williams, J. B. W., & Benjamin, L. S. (1997). Structured Clinical Interview for DSM-IV Axis II Personality Disorders (SCID-II). Washington, DC: American Psychiatric Press.
• Ribeiro da Silva D, Rijo D, Brazao N, Paulo M, Miguel R, Castilho P, Vagos P, Gilbert P, Salekin RT. The efficacy of the PSYCHOPATHY.COMP program in reducing psychopathic traits: A controlled trial with male detained youth. J Consult Clin Psychol. 2021 Jun;89(6):499-513. doi: 10.1037/ccp0000659.
• Sousa, R., Castilho, P., Vieira, C., Vagos, P., & Rijo, D. (2017). Dimensionality and gender-based measurement invariance of the Compassion Scale in a community sample. Personality and Individual Differences, 117, 182-187. https://doi.org/10.1016/j.paid.2017.06.003
• Gilbert P, McEwan K, Matos M, Rivis A. Fears of compassion: development of three self-report measures. Psychol Psychother. 2011 Sep;84(3):239-55. doi: 10.1348/147608310X526511. Epub 2011 Apr 13.
• Sousa R, Paulo M, Brazao N, Castilho P, Rijo D. Measuring compassion toward others: Dimensionality of the compassion scale in community adolescents and in adolescents with behavioral disorders. Psychol Assess. 2022 Jul;34(7):631-642. doi: 10.1037/pas0001133. Epub 2022 Mar 31.
• Ribeiro da Silva, D., de Carvalho, I. M., & Garofalo, C. (2024). Treatment of youth and adults with psychopathic traits detained in forensic settings: A systematic review. Aggression and Violent Behavior, 76, 101922. https://doi.org/10.1016/j.avb.2024.101922
• Coelho, L., Paixão, R., & da Silva, J. T. (2010). O Levenson's Self Report Psychopathy Scale (LSRP). Psychologica, 53, 413-421
• Goss, K., Gilbert, P., & Allan, S. (1994). An exploration of shame measures-I: The other as Shamer scale. Personality and Individual Differences, 17, 713-717. http://dx.doi.org/10.1016/0191-8869(94)90149-X
• Matos, M., Pinto-Gouveia, J., Gilbert, P., Duarte, C., & Figueiredo, C. (2015). The Other As Shamer Scale-2: Development and validation of a short version of a measure of external shame. Personality and Individual Differences, 74, 6-11. https://doi.org/10.1016/j.paid.2014.09.037
• Neff, K. D. (2003). Self-Compassion: An Alternative Conceptualization of a Healthy Attitude Toward Oneself. Self and Identity, 2, 85-101. https://doi.org/10.1080/15298860309032
• Spielberger, C. D. (1988). Professional Manual for the State-Trait Anger Expression Inventory (STAXI). Odessa, FX: Psychological Assessment Resources
• Levenson MR, Kiehl KA, Fitzpatrick CM. Assessing psychopathic attributes in a noninstitutionalized population. J Pers Soc Psychol. 1995 Jan;68(1):151-8. doi: 10.1037//0022-3514.68.1.151.
• Hare, R. D. (2003). Manual for the revised psychopathy checklist (2nd ed.). Toronto, Canada: Multi-Health Systems
• Paulhus, D. L., Neumann, C. S., & Hare, R. D. (2016). The SRP-4: Self-report psychopaty scale (4th ed.). Toronto, Canada: Multi-Health Systems
• Castilho P, Pinto-Gouveia J, Duarte J. Evaluating the Multifactor Structure of the Long and Short Versions of the Self-Compassion Scale in a Clinical Sample. J Clin Psychol. 2015 Sep;71(9):856-70. doi: 10.1002/jclp.22187. Epub 2015 Apr 22.
• Silva, D. R., Campos, R., & Prazeres, N. (1999). O Inventário de Estado-Traço de Raiva (STAXI) e sua adaptação para a população portuguesa. Revista Portuguesa de Psicologia, 34, 55-81
• Seara-Cardoso A, Queiros A, Fernandes E, Coutinho J, Neumann C. Psychometric Properties and Construct Validity of the Short Version of the Self-Report Psychopathy Scale in a Southern European Sample. J Pers Assess. 2020 Jul-Aug;102(4):457-468. doi: 10.1080/00223891.2019.1617297. Epub 2019 Jun 12.
• Knight, R. A., & Guay, J.-P. (2006). The Role of Psychopathy in Sexual Coercion against Women. In C. J. Patrick (Ed.), Handbook of psychopathy (pp. 512-532). The Guilford Press
• Hare, R. D. (2020). The PCL-R assessment of psychopathy. In A. R. Felthous & H. Saß (Eds.), The Wiley International Handbook on Psychopathic Disorders and the Law (pp. 63-106). John Wiley & Sons. https://doi.org/10.1002/9781119159322.ch4
• Brazao N, Rijo D, da Silva DR, do Ceu Salvador M, Pinto-Gouveia J. Personality Pathology Profiles as Moderators of the Growing Pro-Social Program: Outcomes on Cognitive, Emotion, and Behavior Regulation in Male Prison Inmates. J Pers Disord. 2021 Feb;35(1):84-113. doi: 10.1521/pedi_2019_33_424. Epub 2019 Apr 15.
• Gillespie SM, Jones A, Garofalo C. Psychopathy and dangerousness: An umbrella review and meta-analysis. Clin Psychol Rev. 2023 Mar;100:102240. doi: 10.1016/j.cpr.2022.102240. Epub 2022 Dec 13.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Compassion Focused Therapy; PSYCHOPATHY.COMP; Criminality; Antisocial behavior; Psychopathy; Institutional behavior
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Behavior; Antisocial Personality Disorder; Criminal Behavior; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups; Therapeutics
• Other Study ID Numbers: COMPETE2030-FEDER-00641100; CEDI/FPCEUC: 105/R_5 (Other Identifier: Ethics and Research Integrity Committee of the Faculty of Psychology and Educational Sciences, University of Coimbra); doi:10.54499/2023.18296.ICDT (Other Identifier: Portuguese National Funding Agency for Science, Research and Technology (FCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol will be submitted for publication. Participant individual data will be de-identified but will not be shared due to confidentiality and privacy concerns related to the sensitive nature of the participant population. De-identified aggregate data may be available upon reasonable request, subject to ethical approval.
• IPD Sharing Time Frame: Start date: March 2026 - no end date
• IPD Sharing Access Criteria: IPD and supporting information will made open on the Open Science Framework (OSF)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No