Imagery Rescripting for Pathological Affective Dependence and Intimate Partner Violence

NCT ID: NCT06670326

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-02-28

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.

Detailed Description

In this multiple baseline case series study, the effectiveness of Imagery Rescripting (ImRs) as a treatment for Pathological Affective Dependence (PAD) in victims of Intimate Partner Violence (IPV) will be evaluated. Eighteen victims of IPV with PAD will be randomized to different waitlist lengths (5-9 weeks), after which they will enter a 4-session preparation phase (4 weeks), followed by 12 weekly sessions of ImRs. Follow-up assessments will take place at 4 weeks, 6 months, and 12 months post-treatment.

The primary outcomes are:

PAD severity, which will be assessed weekly using the Pathological Affective Dependence Scale.

Relational commitment, measured using a validated scale. The hypothesis is that primary outcomes will show greater reductions during the treatment phase compared to the waitlist or preparation phases and will either stabilize or show further improvement post-treatment.

Similarly, secondary outcomes such as general mental health (measured by the Patient Health Questionnaire, PHQ-9), resilience (assessed with the The Brief Resilience Scale (RSb), and self-compassion (assessed with the Self-compassion Scale short (SCs) are expected to show the most significant improvements from pre- to post-treatment, with minimal changes during baseline, preparation, and post-treatment phases.

The results will be analyzed using multilevel analysis, pooling the effects across individual cases. In addition, participants will be interviewed 4 weeks post-treatment to gather qualitative feedback on their experiences with the treatment.

Conditions

Pathological Affective Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 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.

Group Type: EXPERIMENTAL

Imagery Rescripting

Intervention Type: BEHAVIORAL

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.

Interventions

Imagery Rescripting

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

ImRs

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

VU University of Amsterdam

OTHER

Sponsor Role: collaborator

Stichting Achmea Slachtoffer en Samenleving

OTHER

Sponsor Role: collaborator

University of Amsterdam

OTHER

Sponsor Role: lead

Responsible Party

Erica Pugliese

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erica Pugliese, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Amsterdam

Locations

Associazione Italiana Di Psicoterapia Cognitiva - Aipc

Bari, Italy, Italy

Sterk Huis

Amsterdam, Goirle, Netherlands

University of Amsterdam

Amsterdam, , Netherlands

Countries

Italy; Netherlands

Central Contacts

Erica Pugliese, PhD

Role: CONTACT

e.pugliese@uva.nl

+31 (0)20 525 6810

Arnold van Emmerik, PhD

Role: CONTACT

a.a.p.vanemmerik@uva.nl

+31 (0)20 525 8604

Facility Contacts

Maria Grazia Foschino Barbaro, Psychology

Role: primary

aipc.scuola@gmail.com

+39 351 6208206

Lenke Balogh

Role: primary

LenkeBalogh@sterkhuis.nl

06-43828325

Arnoud Arntz, Phd, Professor

Role: primary

A.R.Arntz@uva.nl

+31 (0)20 525 6810

Arnold van Emmerik, PhD

Role: backup

a.a.p.vanemmerik@uva.nl

+31 (0)20 525 6810

Erica Pugliese, PhD

Role: backup

Other Identifiers

FMG-10908

Identifier Type: -

Identifier Source: org_study_id