Flashforward EMDR Treatment for Patients With an ICD

NCT06174051 | Unknown DMC

• 1 other identifier: 85546
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anxiety and Fear

Keywords

EMDR; Flashforward; Anxiety; ICD

Outcome Measures

Primary Outcomes (1)

• Cardiac Anxiety Questionnaire (CAQ)

  Self-report questionnaire to asses heart focussed anxiety

  Baseline (Before treatment T0), after the first treatment session T1(for wait list after 2 weeks), and after the second treatment session T2 (for wait list after 4 weeks)

Secondary Outcomes (4)

• PTSD Check-List (PCL-5)

  Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)

• General Anxiety Questionnaire (GAD-7)

  Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)

• Patient Health Questionnaire (PHQ-9)

  Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)

• EuroQol (EQ5D-5L)

  Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)

Other Outcomes (1)

• Life Events Checklist (LEC-5)

  Baseline (Before treatment T0)

Study Arms (3)

FF EMDR

EXPERIMENTAL

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

Behavioral: Flashforward EMDR

FB EMDR

ACTIVE COMPARATOR

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

Behavioral: Flashback EMDR

Control group

NO INTERVENTION

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

Interventions

Flashforward EMDR BEHAVIORAL

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

FF EMDR

Flashback EMDR BEHAVIORAL

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

FB EMDR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Leonieke Kranenburg, PhD

CONTACT

+31654276606; l.kranenburg@erasmusmc.nl

Jan Busschbach, PhD

CONTACT

+31681423366; j.vanbusschbach@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 18, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share