Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders (MIT-MDO-PT)
Preliminary Efficacy of the Portuguese Adaptation of Metacognitive Interpersonal Therapy for Male Domestic Offenders (MIT-MDO-PT) in Men Under Judicial Supervision for Intimate Partner Violence With Personality Disorders: A Preregistered Multiple-Baseline Single-Case Experimental Design With Partner-Reported External Validation
This study evaluates the preliminary efficacy of MIT-MDO-PT, the European Portuguese cultural and linguistic adaptation of Metacognitive Interpersonal Therapy for Male Domestic Offenders (MIT-MDO), in adult men under judicial supervision for intimate partner violence (IPV) offences who meet criteria for a personality disorder. MIT-MDO-PT is an individual psychotherapy of 24 weekly 50-minute sessions delivered over approximately six months in four phases (case formulation and metacognitive assessment; mentalization and affect regulation; memory rescripting and shame transformation; consolidation and relapse prevention). The study uses a preregistered nonconcurrent multiple-baseline single-case experimental design across participants (target N = 5-7; enrolment ceiling 7): each participant completes a baseline phase with weekly monitoring (target of five data points), and treatment onsets are fixed a priori and staggered by at least three weeks between participants to provide internal experimental control without randomization. Primary outcomes are self-reported IPV perpetration (Revised Conflict Tactics Scales, CTS2), metacognition (Metacognition Self-Assessment Scale, MSAS) and personality pathology (Personality Inventory for DSM-5, PID-5), assessed at baseline (T0), after sessions 8 (T1), 16 (T2) and 24 (T3) and at 8-10-week follow-up (T4), with weekly monitoring of IPV (CTS2 physical assault and psychological aggression subscales) and psychological distress (CORE-10) throughout baseline and treatment. Where available, partners are assessed independently by a hospital victim-support service at T0 and T3 (Danger Assessment-5, CTS2 partner version, Psychological Maltreatment of Women Inventory-Short Form). Outcome assessment at T0, T3 and T4 is performed by an assessor independent of the therapist. Objectively recorded violence-related incidents (police or judicial occurrences, breaches notified by the supervising services, hospital safety-protocol activations) are collected as a secondary outcome. Analyses are conducted per participant (reliable change index, percentage of non-overlapping data, non-overlap of all pairs, Tau-U, structured visual analysis), with study-level conclusions based on replication across participants. Treatment fidelity is monitored through structured session notes and blind rating of 20% of sessions. The study is preregistered on the Open Science Framework (osf.io/wqpnc; protocol update v3.1, September 2026) and has a favourable opinion from the Ethics Committee of the University of Beira Interior, subject to the formal authorizations of the referring institutions.
研究概览
地位
详细说明
Background. Court-mandated psychoeducational programmes for intimate partner violence (IPV) perpetrators show small or null effects on recidivism and high attrition, particularly among men with personality pathology. Metacognitive Interpersonal Therapy (MIT) targets the metacognitive dysfunctions (monitoring, differentiation, integration, decentration, mastery) and maladaptive interpersonal schemas that underlie personality disorders. Its adaptation to male domestic offenders (MIT-MDO) has shown promising results in a proof-of-concept case series (Pasetto et al., 2026). The European Portuguese adaptation (MIT-MDO-PT) was developed following established cross-cultural adaptation standards and is preregistered separately (osf.io/r2x8g). The study protocol is registered on the Open Science Framework (osf.io/wqpnc; update v3.1, September 2026).
Design. Nonconcurrent multiple-baseline single-case experimental design across participants (single series; participants enter at different calendar times). Phase A (baseline): weekly monitoring with a target of five data points (minimum of three only when imminent risk requires earlier treatment; no data-dependent extension), using the brief monitoring set (CTS2 physical assault and psychological aggression subscales, 1-week recall, plus CORE-10). Phase B (intervention): 24 individual weekly sessions. Treatment onsets are fixed a priori, before baseline data are inspected, and staggered by at least three weeks between participants irrespective of referral pathway, so that the A-to-B change occurs at each participant's own onset rather than at a common calendar time, controlling for maturation, history and instrumentation drift. No randomization. Outcome assessment at T0, T3 (including the SCID-5-PD) and T4 is performed by the same assessor, independent of the therapist; the weekly series is self-completed on a secure platform before each session without the therapist present. Treatment fidelity is rated blindly on 20% of sessions by an independent rater (inter-rater ICC target >= .80 on 10% of rated sessions). Participants at imminent risk of harming the victim move directly to treatment, and the deviation is reported.
Assessment schedule. T0 (baseline): complete battery. T1 (after Session 8): CTS2, MSAS, CORE-OM, IRI. T2 (after Session 16): T1 set plus EDRE, IIP-32, TOSCA-3. T3 (after Session 24): complete battery and exit interview. T4 (8-10 weeks after Session 24): CTS2, MSAS, PID-5, IIP-32, CORE-OM, TOSCA-3, IRI. Weekly throughout Phases A and B: CTS2 physical assault and psychological aggression subscales and CORE-10 (act counts, 1-week recall). CTS2 at T1-T4 uses a "since the last assessment" recall period. Recorded violence-related incidents (new police or judicial occurrences, breaches of the judicial measure notified by DGRSP, activations of the hospital safety protocol) are logged per participant and phase as an objective secondary outcome; a serious adverse event is defined a priori and a study-level stopping rule applies. Screening for psychopathy: candidates meeting SCID-5-PD criteria for antisocial personality disorder complete the Self-Report Psychopathy Scale - Short Form (SRP-SF, Portuguese version); a total score of 70 or above is exclusionary. WAI-SR at Sessions 4, 8, 12, 16, 20 and 24.
Partner assessment. Administered exclusively by the victim-support team of Hospital Beatriz Angelo at T0 and T3, in fixed order: Danger Assessment-5 first (an elevated score immediately triggers the hospital safety protocol), then CTS2 partner version and PMWI-SF. Partner data are stored by the hospital separately from the research database; the research team receives de-identified data only. Two to five complete dyads are expected.
Analysis. No group-level inferential models. Per participant: reliable change index (Jacobson & Truax) with |RCI| >= 1.96; percentage of non-overlapping data (PND >= 70%) and non-overlap of all pairs (NAP >= 0.66) on the weekly series, with Tau-U (uncorrected as the main index; trend-corrected as sensitivity analysis) and baseline-to-treatment rate difference; structured visual analysis following a named protocol (level, trend, variability, immediacy, overlap, consistency). Partner-exposure stratum (cohabiting, regular contact, no contact) is recorded and reported for the interpretation of the weekly IPV series. Participant-level decision: RCI criterion met plus at least one corroborating criterion. Study-level support when replicated in at least 3 of 5 participants (at least 4 if N = 6-7). Temporal precedence of metacognitive change over violence reduction examined by visual analysis (exploratory). Dyad-level concordance and change in number of personality disorder diagnoses are descriptive. Missing items below 20% within a scale are imputed by person mean; 20% or more, the score is not computed; no imputation of weekly series; last observation carried forward only as sensitivity analysis. Analysis code is written before data access.
Therapist and supervision. The intervention is delivered by the principal investigator (formal MIT training, Levels I-III) under weekly clinical supervision by the developer of MIT-MDO. Fidelity: structured session notes for all sessions; blind rating of 20% of sessions with the MIT-MDO-PT Session Fidelity Checklist; adherence threshold >= 80% for inclusion in primary efficacy analyses.
Start condition. Recruitment, data collection and intervention begin, for each referral pathway, only after the formal authorization of the corresponding referring institution (Hospital Beatriz Angelo; Directorate-General for Reintegration and Prison Services) has been presented to the Ethics Committee of the University of Beira Interior, closing the condition attached to its favourable opinion; the two pathways may open on different dates. Enrolment window: January to June 2027; ceiling of 7 participants including dropouts; replacement only before Session 12 and within the window; fewer than three completers triggers a feasibility report. Participants referred by the hospital are seen at the Centre for the Rehabilitation of Domestic Violence Perpetrators (CRAVDA) of Loures Municipality; the site for participants referred by the prison and reintegration services will be specified before that pathway opens.
Data sharing. De-identified participant-level data and analysis code will be deposited on the Open Science Framework at study end, subject to ethical and legal constraints; partner-reported data only in aggregate form.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Hugo C Vicente, MSc
- 电话号码:+351 913103116
- 邮箱:hugo.cesar.vicente@ubi.pt
学习地点
-
-
Lisbon District
-
Loures、Lisbon District、葡萄牙
- Centre for the Rehabilitation of Domestic Violence Perpetrators (CRAVDA), Loures Municipality
-
接触:
- Hugo C Vicente
- 电话号码:+351 913103116
- 邮箱:hugo.cesar.vicente@ubi.pt
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Male, aged 18 years or older
- Under judicial supervision (e.g., suspended sentence, provisional suspension of proceedings, or other court-ordered measure) for intimate partner violence offences, referred by the Directorate-General for Reintegration and Prison Services (DGRSP) or by the Hospital Beatriz Ângelo victim-support service
- Personality disorder confirmed by the SCID-5-PD (at least one diagnosis) AND elevation of at least one PID-5 domain (T-score >= 60, Portuguese norms)
- Current or recent intimate partner violence perpetration
- Voluntary informed consent, given independently of the judicial mandate
- Fluency in Portuguese
- Ability to commit to the 24-session weekly protocol
Exclusion Criteria:
- Psychopathy, operationalised as antisocial personality disorder confirmed by the SCID-5-PD together with a total score of 70 or above on the Self-Report Psychopathy Scale - Short Form (SRP-SF, European Portuguese version), administered at screening only to candidates meeting antisocial personality disorder criteria; clinical indicators from the screening interview and the referral file (generalised instrumental violence, absence of remorse and of affective bonding) are recorded as supporting information
- Active psychosis or severe cognitive impairment
- Imminent risk of harm to the victim requiring immediate protective intervention
- Substance dependence requiring concurrent intensive treatment
- Concurrent psychotherapy (ongoing pharmacotherapy is permitted)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:MIT-MDO-PT
Adult men under judicial supervision for intimate partner violence with a personality disorder receive 24 individual weekly 50-minute sessions of MIT-MDO-PT after a baseline phase with weekly monitoring (target of five weekly data points; minimum of three only under imminent risk). Treatment onsets are fixed a priori and staggered by at least three weeks between participants (nonconcurrent multiple-baseline design). |
Manualised individual psychotherapy (24 weekly sessions, 50 minutes, approximately 6 months) adapted to European Portuguese from MIT-MDO. Phase I (Sessions 1-8): shared case formulation and metacognitive assessment; Phase II (Sessions 9-16): mentalization and affect regulation; Phase III (Sessions 17-21): memory rescripting and shame transformation; Phase IV (Sessions 22-24): consolidation and relapse prevention. Delivered by a psychologist trained in MIT (Levels I-III) under weekly clinical supervision by the model developer. Fidelity: structured session notes (100% of sessions) and blind rating of 20% of sessions with the MIT-MDO-PT Session Fidelity Checklist; adherence threshold >= 80%.
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in self-reported intimate partner violence perpetration (CTS2)
大体时间:Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
|
Revised Conflict Tactics Scales (CTS2), perpetration scales (physical assault, psychological aggression, sexual coercion, injury); European Portuguese version. Metric: reliable change index (RCI, Jacobson & Truax) between T0 and T3; |RCI| >= 1.96 indicates reliable change; decrease = improvement. |
Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
|
|
Change in metacognition (MSAS)
大体时间:Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
|
Metacognition Self-Assessment Scale (MSAS; Pedone et al., 2017; European Portuguese version: Faustino et al., 2021; 18 items; total score and four factor scores: self-reflexivity, critical distance, mastery, understanding other minds). Metric: RCI between T0 and T3 on the total score (|RCI| >= 1.96; increase = improvement). Factor scores reported descriptively. |
Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
|
|
Change in personality pathology (PID-5)
大体时间:Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
|
Personality Inventory for DSM-5 (PID-5), adult form, five domain scores (T-scores, Portuguese norms). Metric: RCI between T0 and T3 per domain (|RCI| >= 1.96; decrease = improvement). Facets reported descriptively. |
Baseline (T0) and end of treatment (T3, after Session 24, approximately 6 months after treatment onset)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Weekly intimate partner violence monitoring series (CTS2 subscales)
大体时间:Weekly from start of baseline (target of five weekly points) through Session 24 (approximately 7-8 months per participant)
|
Sum of CTS2 physical assault and psychological aggression subscales (act counts, 1-week recall), self-completed by the participant on a secure platform before each session, collected weekly throughout baseline (Phase A) and treatment (Phase B). Metrics: percentage of non-overlapping data (PND >= 70%) and non-overlap of all pairs (NAP >= 0.66) between Phase A and Phase B, Tau-U (uncorrected as main index; trend-corrected as sensitivity analysis) with 95% CI, baseline-to-treatment rate difference, plus structured visual analysis following a named protocol (level, trend, variability, immediacy, overlap, consistency). Reported by partner-exposure stratum (cohabiting, regular contact, no contact). |
Weekly from start of baseline (target of five weekly points) through Session 24 (approximately 7-8 months per participant)
|
|
Weekly psychological distress (CORE-10)
大体时间:Weekly from start of baseline (3-5 weeks) through Session 24 (approximately 7-8 months per participant)
|
CORE-10 total score collected weekly throughout Phases A and B. Metrics: PND, NAP and structured visual analysis, Phase A versus Phase B. |
Weekly from start of baseline (3-5 weeks) through Session 24 (approximately 7-8 months per participant)
|
|
Maintenance of gains at follow-up (CTS2, MSAS, PID-5)
大体时间:Baseline (T0) and follow-up (T4, 8-10 weeks after Session 24)
|
RCI between T0 and T4 on the CTS2, MSAS total score and PID-5 domains; maintenance supported when |RCI| >= 1.96 with no reliable deterioration between T3 and T4. |
Baseline (T0) and follow-up (T4, 8-10 weeks after Session 24)
|
|
Change in global psychological distress (CORE-OM)
大体时间:Baseline (T0), 8 weeks (T1), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
|
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), total score, Portuguese version. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement). |
Baseline (T0), 8 weeks (T1), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
|
|
Change in interpersonal problems (IIP-32)
大体时间:Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
|
Inventory of Interpersonal Problems - 32 items (IIP-32), total score. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement). |
Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
|
|
Change in emotion dysregulation (EDRE/DERS)
大体时间:Baseline (T0), 16 weeks (T2) and 24 weeks (T3, end of treatment) after treatment onset
|
Difficulties in Emotion Regulation Scale, Portuguese version (EDRE), total score. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement). |
Baseline (T0), 16 weeks (T2) and 24 weeks (T3, end of treatment) after treatment onset
|
|
Change in impulsivity (SUPPS-P)
大体时间:Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
Short UPPS-P Impulsive Behavior Scale (SUPPS-P), total and facet scores, Portuguese version. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement). |
Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
|
Change in alexithymia (TAS-20)
大体时间:Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
Toronto Alexithymia Scale - 20 items (TAS-20), total score, Portuguese version. Metric: RCI T0-T3 (|RCI| >= 1.96; decrease = improvement). |
Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
|
Change in shame- and guilt-proneness (TOSCA-3)
大体时间:Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
|
Test of Self-Conscious Affect (TOSCA-3), shame-proneness and guilt-proneness scales. Metric: RCI T0-T3 (|RCI| >= 1.96). |
Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
|
|
Change in number of personality disorder diagnoses (SCID-5-PD)
大体时间:Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD): number of personality disorder diagnoses met. Descriptive reporting only (no inferential threshold). |
Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
|
Partner-reported intimate partner violence (CTS2-P and PMWI-SF) - external validation
大体时间:Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
CTS2 partner version (CTS2-P) and Psychological Maltreatment of Women Inventory - Short Form (PMWI-SF), administered exclusively by hospital victim-support staff. Metric: per-informant change classification and dyad-level concordance category with perpetrator report (descriptive); ICC(2,1) exploratory only if at least 5 complete dyads. |
Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
|
Temporal precedence of metacognitive change over violence reduction (exploratory)
大体时间:Baseline (T0) through 24 weeks after treatment onset (T3, end of treatment)
|
Per-participant visual analysis of the MSAS trajectory (T0-T2) and the weekly CTS2 monitoring series, classified as temporal precedence present, absent or indeterminate. No formal mediation model (N = 5-7). |
Baseline (T0) through 24 weeks after treatment onset (T3, end of treatment)
|
|
Recorded violence-related incidents
大体时间:From consent through follow-up (T4, 8-10 weeks after Session 24; approximately 11 months per participant)
|
Objectively recorded events, independent of self-report: new police or judicial occurrences for violence, breaches of the judicial measure notified by the Directorate-General for Reintegration and Prison Services, and activations of the hospital safety protocol. Counts per participant and per phase (baseline, treatment, follow-up), reported descriptively without a formal hypothesis. Any incident meeting the a priori definition of a serious adverse event is reported to the Ethics Committee and triggers the study-level stopping rule. |
From consent through follow-up (T4, 8-10 weeks after Session 24; approximately 11 months per participant)
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Working alliance (WAI-SR)
大体时间:Weeks 4, 8, 12, 16, 20 and 24 after treatment onset (Sessions 4, 8, 12, 16, 20 and 24)
|
Working Alliance Inventory - Short Revised (WAI-SR), total score; descriptive process variable. |
Weeks 4, 8, 12, 16, 20 and 24 after treatment onset (Sessions 4, 8, 12, 16, 20 and 24)
|
|
Empathy (IRI)
大体时间:Baseline (T0), 8 weeks (T1), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
|
Interpersonal Reactivity Index (IRI), subscale scores, Portuguese version; descriptive process variable. |
Baseline (T0), 8 weeks (T1), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset
|
|
Treatment fidelity index (TFI)
大体时间:Throughout treatment (24 weekly sessions, approximately 6 months)
|
Percentage of protocol-required elements implemented per session, rated blindly by an independent rater on 20% of sessions with the MIT-MDO-PT Session Fidelity Checklist; inter-rater reliability (ICC) on 10% of rated sessions; participant mean >= 80% required for inclusion in primary efficacy analyses. |
Throughout treatment (24 weekly sessions, approximately 6 months)
|
|
Partner danger assessment (DA-5) - safety screening
大体时间:Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
Danger Assessment-5 (DA-5), administered first at each partner assessment by hospital victim-support staff; an elevated score triggers the hospital safety protocol. Descriptive reporting. |
Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment)
|
|
Feasibility: number of treatment sessions attended (retention)
大体时间:Through end of treatment, 24 weeks after treatment onset
|
Number of MIT-MDO-PT sessions attended by each participant, out of 24 scheduled sessions. Descriptive reporting per participant; completion defined as attendance at 20 or more sessions. |
Through end of treatment, 24 weeks after treatment onset
|
|
Feasibility: recruitment rate
大体时间:Through end of enrolment window, up to 6 months from study start
|
Number of participants enrolled per month during the enrolment window (January to June 2027), by referral pathway. Descriptive reporting. |
Through end of enrolment window, up to 6 months from study start
|
|
Feasibility: percentage of scheduled assessments completed
大体时间:Through follow-up, 32-34 weeks after treatment onset (T4)
|
Percentage of scheduled assessment occasions (T0 to T4 and weekly monitoring points) completed by each participant. Descriptive reporting. |
Through follow-up, 32-34 weeks after treatment onset (T4)
|
|
Feasibility: number of complete partner dyads
大体时间:Through end of treatment, 24 weeks after treatment onset (T3)
|
Number of participants for whom the partner completed both partner assessments (T0 and T3) with the hospital victim-support service. Descriptive reporting. |
Through end of treatment, 24 weeks after treatment onset (T3)
|
|
Feasibility: number of participants who discontinued, by reason
大体时间:Through end of treatment, 24 weeks after treatment onset (T3)
|
Number of participants who discontinued the intervention before Session 24, classified by reason for discontinuation (e.g., withdrawal of consent, breach of judicial measure, relocation, exclusion for safety). Descriptive reporting. |
Through end of treatment, 24 weeks after treatment onset (T3)
|
合作者和调查者
调查人员
- 首席研究员:Hugo C Vicente, MSc、University of Beira Interior
出版物和有用的链接
一般刊物
- Misso D, Schweitzer RD, Dimaggio G. Metacognition and mentalization in intimate partner violence perpetrators: Theoretical and clinical implications. J Psychother Integr. 2019;29(4):359-375. doi:10.1037/int0000111
- Pasetto A, Misso D, Velotti P, Dimaggio G. Metacognitive interpersonal therapy for male domestic offenders (MIT-MDO) with personality disorders: A proof-of-concept case series. Psychol Psychother. 2026 Jun;99(2):463-483. doi: 10.1111/papt.70036. Epub 2026 Jan 5.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- MIT-MDO-PT-A2-2026
- osf.io/wqpnc (其他标识符:Open Science Framework (study preregistration, protocol v3.1))
- CE-UBI-Pj-2026-044-ID-8651 (其他标识符:Ethics Committee of the University of Beira Interior (CE-UBI))
- osf.io/r2x8g (其他标识符:Open Science Framework (cultural adaptation preregistration, DOI 10.17605/OSF.IO/R2X8G))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
De-identified participant-level data (weekly repeated measures and pre/post questionnaire scores) and the analysis code will be deposited on the Open Science Framework (OSF) project page at study completion, subject to ethical and legal constraints (judicially supervised participants; approval by the UBI Ethics Committee). Partner-reported data will be shared only in aggregate or fully de-identified form to protect victim safety. Session recordings and clinical notes will not be shared.
IPD 共享时间框架
Data and code will become available within 12 months after study completion (anticipated by December 2028) and will remain available indefinitely on OSF.
IPD 共享访问标准
Open access to de-identified quantitative data and code via OSF. Any request for additional variables will be assessed by the Principal Investigator and the UBI Ethics Committee, in accordance with GDPR and Portuguese law; data-use agreements may be required.
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.