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Flashforward EMDR Treatment for Patients With an ICD

NCT ID: NCT06174051

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2025-07-31

Brief Summary

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The goal of this randomized controlled trial is to test whether flashforward (FF) EMDR alone is effective in reducing anxiety symptoms in patients with an implantable cardioverter defibrillator (ICD). Participants will fill out several questionnaires to asses their level of anxiety, depression symptoms and quality of life before, during and after treatment.

Detailed Description

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Patients with an implantable cardioverter defibrillator (ICD) are at risk of ventricular arrhythmias (VA). The ICD is a device that can treat VA by antitachycardia pacing or ICD shocks. Since ICD shocks are painful and unpredictable, patients with an ICD can suffer from anxiety symptoms. Eye movement desensitization and reprocessing treatment (EMDR) is an effective treatment to enhance the process of traumatic events. In addition, this treatment has also shown to be able to reduce anxiety symptoms. EMDR treatment according to standard protocol starts with flashback (FB) procedure and may be followed by the flashforward (FF) procedure. The FB procedure focusses on events that happened in the past, while the FF procedure aims to reduce fear evoked by images of imagined future adverse events. So far, it is not clear whether the FB procedure is always necessary for the EMDR treatment to be effective. Moving straight towards application of the FF procedure (without first applying the FB procedure), may save treatment time and costs. Therefore, the main objective in this study is to test whether flashforward (FF) EMDR alone is effective in reducing anxiety symptoms in ICD patients. This will be tested with a pilot randomized controlled trial with a three-arm repeated measures design. Subjects will either receive FF EMDR, FB EMDR or no EMDR during the study. To measure their heart focussed anxiety, subjects will fill out the Cardiac Anxiety Questionnaire (CAQ) before, during and after treatment or waiting period.

Conditions

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Anxiety and Fear

Keywords

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EMDR Flashforward Anxiety ICD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In this study, three groups are compared in a parallel setting. One group will receive EMDR following the flashforward procedure, one group will receive EMDR following the flashback procedure, and the last group will be on a wait list and fill out the questionnaires without receiving EMDR treatment.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The study will have an open label, since the care provider (the psychologist) needs to know which procedure to follow and the participants will understand in which group they are once the therapy start.

Study Groups

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FF EMDR

Subjects in this group will receive two EMDR treatment sessions following the flashforward protocol.

Group Type EXPERIMENTAL

Flashforward EMDR

Intervention Type BEHAVIORAL

The Flashforward procedure in EMDR-treatment aims to reduce fear evoked by images of imagined future adverse events.

FB EMDR

Subjects in this group will receive two EMDR treatment sessions following the flashback protocol.

Group Type ACTIVE_COMPARATOR

Flashback EMDR

Intervention Type BEHAVIORAL

The Flashback procedure in EMDR-treatment aims to successfuly process the memories of traumatic events that happened in the past.

Control group

Subjects in this group will not receive any treatment until the wait list period (4 weeks) is over

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Flashforward EMDR

The Flashforward procedure in EMDR-treatment aims to reduce fear evoked by images of imagined future adverse events.

Intervention Type BEHAVIORAL

Flashback EMDR

The Flashback procedure in EMDR-treatment aims to successfuly process the memories of traumatic events that happened in the past.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* subjects have an ICD;
* subjects have clinical anxiety symptoms related to their ICD.

Exclusion Criteria

* insufficient knowledge on Dutch or English language;
* severe psychiatric disorders that warrant (other) psychiatric first, such as suicidality or psychotic disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Leonieke Kranenburg

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Leonieke Kranenburg, PhD

Role: CONTACT

Phone: +31654276606

Email: [email protected]

Jan Busschbach, PhD

Role: CONTACT

Phone: +31681423366

Email: [email protected]

Other Identifiers

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85546

Identifier Type: -

Identifier Source: org_study_id