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ClinicalTrials.gov ID

NCT06670326

Lead Sponsor

University of AmsterdamOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

18Estimated

Last Update Posted

Nov 1, 2024Actual

Start Date

Feb 1, 2025Estimated

Primary Completion Date

May 2025Estimated

Completion Date

Feb 2026Estimated

Official Title

Imagery Rescripting As a Treatment for Pathological Affective Dependence: Helping Victims Break Free from Abusive Relationships

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.

• Pathological Affective Dependence

• Imagery Rescripting

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

University of AmsterdamOTHER

Collaborators

VU University of AmsterdamOTHER

Stichting Achmea Slachtoffer en SamenlevingOTHER

A.R.Arntz@uva.nl+31 (0)20 525 6810