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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in self-reported intimate partner violence perpetration (CTS2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Single-group, open-label design. Outcome assessment at baseline (T0), end of treatment (T3, including the SCID-5-PD) and follow-up (T4) is performed by the same assessor, independent of the therapist and not involved in treatment delivery. The weekly monitoring series is self-completed by the participant on a secure platform before each session, without the therapist present. T1 and T2 assessments are unblinded. Treatment fidelity is rated by an independent rater blind to outcome data on 20% of sessions.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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).
干预措施: Metacognitive Interpersonal Therapy for Male Domestic Offenders, Portuguese adaptation (MIT-MDO-PT) (Behavioral)
结局指标
主要结局
Change in self-reported intimate partner violence perpetration (CTS2)
时间窗: 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.
Change in metacognition (MSAS)
时间窗: 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.
Change in personality pathology (PID-5)
时间窗: 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.
次要结局
- Change in interpersonal problems (IIP-32)(Baseline (T0), 16 weeks (T2), 24 weeks (T3, end of treatment) and 32-34 weeks (T4, follow-up) after treatment onset)
- Weekly intimate partner violence monitoring series (CTS2 subscales)(Weekly from start of baseline (target of five weekly points) through Session 24 (approximately 7-8 months per participant))
- Weekly psychological distress (CORE-10)(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)(Baseline (T0) and follow-up (T4, 8-10 weeks after Session 24))
- Change in global psychological distress (CORE-OM)(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 emotion dysregulation (EDRE/DERS)(Baseline (T0), 16 weeks (T2) and 24 weeks (T3, end of treatment) after treatment onset)
- Change in impulsivity (SUPPS-P)(Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment))
- Change in alexithymia (TAS-20)(Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment))
- Change in shame- and guilt-proneness (TOSCA-3)(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)(Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment))
- Partner-reported intimate partner violence (CTS2-P and PMWI-SF) - external validation(Baseline (T0) and 24 weeks after treatment onset (T3, end of treatment))
- Temporal precedence of metacognitive change over violence reduction (exploratory)(Baseline (T0) through 24 weeks after treatment onset (T3, end of treatment))
- Recorded violence-related incidents(From consent through follow-up (T4, 8-10 weeks after Session 24; approximately 11 months per participant))
研究者
Hugo César Vicente
Principal Investigator, Doctoral Programme in Clinical and Health Psychology
University of Beira Interior
