NCT06670326

Brief Summary

The goal of this multiple baseline case series study is to evaluate the effectiveness of Imagery Rescripting for Pathological Affective Dependence (PAD) in victims of Intimate Partner Violence (IPV). The primary research questions are: Does Imagery Rescripting reduce PAD and/or commitment to the abusive relationship after separation? Does Imagery Rescripting also reduce traumatic symptoms? Does Imagery Rescripting improve general mental health, self-compassion, and resilience in IPV victims? Participants will undergo a waiting period of 5-9 weeks (to assess time effects without treatment), followed by 4 weekly preparation sessions, 12 weekly Imagery Rescripting sessions, and 1 month of post-treatment. Throughout the study, participants will rate the severity of PAD and relational commitment on a weekly basis. They will also complete more detailed questionnaires assessing mental health, traumatic symptoms, resilience, and self-compassion before each phase, at 1 month post-treatment, 3 months post-treatment, and during follow-ups at 6 and 12 months.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
2 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 1, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 1, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 17, 2024

Last Update Submit

October 30, 2024

Conditions

Keywords

Imagery RescriptingPathological Affective DependenceTreatmentintimate partner violence

Outcome Measures

Primary Outcomes (2)

  • Pathological Affective Dependence Scale (PADS)

    The PADS (Pugliese et al., 2024) is a 17-item Likert-type scale designed to assess both the state and trait manifestations of Pathological Affective Dependence (PAD), particularly focusing on the factors that compel individuals to remain in abusive relationships. These factors include internal conflict, the inability to separate from an abusive partner, and experiences of partner abuse. The scale is administered twice, with instructions tailored to measure both state and trait PAD. Each item is rated on a 5-point Likert scale, where 1 = not at all, 2 = slightly, 3 = sometimes, 4 = often, and 5 = always.

    22-32 weeks plus 3, 6 and 12 months follow-ups

  • Relational Commitment (RC)

    The seven items of the Relationship Commitment scale (Rusbult, Martz, \& Agnew, 1998) include the following items: for example, "I am committed to maintaining my relationship with my partner"; "I want our relationship to last for a very long time"; "I feel very attached to our relationship". Responses are rated on an 8-point scale ranging from 1 (Do not agree at all) to 8 (Agree completely).

    22-32 weeks plus 3, 6 and 12 months follow-ups

Secondary Outcomes (5)

  • Patient Health Questionnaire (PHQ-9 and PHQ-15)

    before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups

  • Self-compassion Scale short (SCs)

    before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups

  • Psychological General Well-Being Index (PGWB-S)

    before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups

  • The Brief Resilience Scale (RSb)

    before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups

  • Generalized Anxiety Disorder 7-item Scale (GAD-7)

    before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups

Other Outcomes (1)

  • patients' experiences

    4 weeks after end of treatment

Study Arms (1)

Baseline-Preparation-Imagery Rescripting-Post Treatment

EXPERIMENTAL

Each participant follows this sequence: (1) 5-9 weeks waitlist during which no treatment is offered; (2) 4 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The ImRs treatment will be based upon the protocol described by Arntz \& Weertman (1999). This protocol can be modified to tailor the needs of this study more specifically. (4) After end of active treatment (ImRs) 4 weeks follow during which only weekly assessments are done.

Behavioral: Imagery Rescripting

Interventions

Experimental: Baseline-Preparation-Imagery Rescripting-Post Treatment Each participant follows this sequence: (1) 5-9 weeks waitlist during which no treatment is offered; (2) 4 weekly preparatory sessions. During these sessions the rationale of ImRs will be explained in more detail and a list of painful (childhood) memories to be addressed with ImRs is to be compiled, based on any further input from the patient; and a case conceptualization is made; (3) 12 sessions (45-60 minutes) of ImRs will be offered to participating patients. The treatment for PAD will be based upon the protocol described by Arntz \& Weertman (1999); (4) After end of active treatment (ImRs) 4 weeks follow during which only weekly assessments are done.

Also known as: ImRs
Baseline-Preparation-Imagery Rescripting-Post Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Experience of IPV (from a clinical interview)
  • Pathological Affective Dependence scale (PADS - Trait, State). As a prerequisite for PAD treatment and study participation, victims of IPV are required to establish a contact with the anti-violence center or shelters to receive co-assistance. The anti-violence center will take care of his/her physical safety and legal aspects.

You may not qualify if:

  • Comorbidity with the following diagnoses: psychosis, schizophrenia, bipolar disorder (conditions derived from a clinical interview or previous diagnostic reports), dissociative disorders (Dissociative Experience Scale, DES).
  • Organic brain disease
  • Intelligence Quotient (IQ) \< 80
  • High risk of self-harm or suicide
  • Current substance abuse severe level
  • Start of new medication within 2 months before beginning the study (medication used for longer periods can be continued; patients are requested to keep medication stable during the course of the study)
  • Having received ImRs (either as a stand-alone or embedded in a greater treatment such as cognitive behavior therapy (CBT) or schema therapy) within the last year
  • No other evidence-based treatment of MDD is allowed during the study.
  • Not able to plan enough time for weekly therapy sessions (45-60 minutes); weekly measurements (estimate of 5 minutes) and other measurements (estimate of 20 minutes); and the qualitative post-treatment interview (estimate of 60 minutes) during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Associazione Italiana Di Psicoterapia Cognitiva - Aipc

Bari, Italy, 70125, Italy

Location

Sterk Huis

Amsterdam, Goirle, Rillaersebaan 75 5053 EA, Netherlands

Location

University of Amsterdam

Amsterdam, Netherlands

Location

Study Officials

  • Erica Pugliese, PhD

    University of Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Pugliese, PhD

CONTACT

Arnold van Emmerik, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The investigator will not have access to assignment of participants to waitlist length and the data until data collection is complete.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Multiple baseline case series design: by randomizing participants to different lengths of waitlist (baseline) and comparing means and slopes of weekly reported Pathological Affective Dependence severity and mental health measures, the effectiveness of the treatment is tested.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 17, 2024

First Posted

November 1, 2024

Study Start

February 1, 2025

Primary Completion

May 1, 2025

Study Completion

February 1, 2026

Last Updated

November 1, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

because of privacy regulations individual patient data cannot be shared, unless the European Union (EU) regulations on data protection are guaranteed.

Locations