Clinical trial NCT06670326: Imagery Rescripting for Pathological Affective Dependence and Intimate Partner Violence
Official title: Imagery Rescripting As a Treatment for Pathological Affective Dependence: Helping Victims Break Free from Abusive Relationships
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pathological Affective Dependence
Keywords: Imagery Rescripting
Pathological Affective Dependence
Treatment
intimate partner violence
Lead sponsor: University of Amsterdam
Sponsor class: OTHER
Collaborators: name: VU University of Amsterdam
name: Stichting Achmea Slachtoffer en Samenleving
First posted: 2024-11-01
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Pathological Affective Dependence Scale (PADS)
timeFrame: 22-32 weeks plus 3, 6 and 12 months follow-ups
measure: Relational Commitment (RC)
timeFrame: 22-32 weeks plus 3, 6 and 12 months follow-ups
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9 and PHQ-15)
timeFrame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
measure: Self-compassion Scale short (SCs)
timeFrame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
measure: Psychological General Well-Being Index (PGWB-S)
timeFrame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
measure: The Brief Resilience Scale (RSb)
timeFrame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
measure: Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: before baseline, before preparatory sessions, before ImRs treatment, 4 weeks after ImRs treatment, 3, 6 and 12 months follow-ups
Other outcomes:
measure: patients' experiences
timeFrame: 4 weeks after end of treatment
Locations:
city: Bari
country: Italy
facility: Associazione Italiana Di Psicoterapia Cognitiva - Aipc
city: Amsterdam
country: Netherlands
facility: Sterk Huis
state: Goirle
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
Study officials:
affiliation: University of Amsterdam
name: Erica Pugliese, PhD
role: PRINCIPAL_INVESTIGATOR
References: