Anxiety and FeareFFectiveNCT06174051
Flashforward EMDR Treatment for Patients With an ICD
A study testing Flashforward EMDR and Flashback EMDR in people with Anxiety and Fear, run by Erasmus Medical Center.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- Flashforward EMDR and Flashback EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects have an ICD;
- subjects have clinical anxiety symptoms related to their ICD.
Who cannot join
- insufficient knowledge on Dutch or English language;
- severe psychiatric disorders that warrant (other) psychiatric first, such as suicidality or psychotic disorders
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effectiveness of Flashforward EMDR Treatment for Patients With an ICD
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.
Read the detailed description
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
- Anxiety and Fear
- Being tested
- Flashforward EMDR, Flashback EMDR
- Keywords
- EMDR, Flashforward, Anxiety, ICD
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flashforward EMDRBehavioural
The Flashforward procedure in EMDR-treatment aims to reduce fear evoked by images of imagined future adverse events.
Flashback EMDRBehavioural
The Flashback procedure in EMDR-treatment aims to successfuly process the memories of traumatic events that happened in the past.
| Study group | Role | What they receive |
|---|---|---|
| FF EMDR | Experimental | Subjects in this group will receive two EMDR treatment sessions following the flashforward protocol. Receives: Behavioral: Flashforward EMDR |
| FB EMDR | Active comparator | Subjects in this group will receive two EMDR treatment sessions following the flashback protocol. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Anxiety Questionnaire (CAQ)
Self-report questionnaire to asses heart focussed anxiety
Measured: 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)
Self-report questionnaire to examine PTSD symptoms
Measured: Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
General Anxiety Questionnaire (GAD-7)
Self-report questionnaire to examine general anxiety symptoms
Measured: Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
Patient Health Questionnaire (PHQ-9)
Self-report questionnaire to examine depression symptoms
Measured: Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
EuroQol (EQ5D-5L)
Self-report questionnaire to examine quality of life
Measured: Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonieke Kranenburg, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174051
- Sponsor's protocol ID
- 85546
- Acronym
- eFFective
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available, anonymized, to other researchers, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Flashforward EMDR Treatment for Patients With an ICD
- ClinicalTrials.gov ID
- NCT06174051
- Acronym / sponsor ID
- eFFective / 85546
- Conditions
- Anxiety and Fear
- Keywords
- EMDR, Flashforward, Anxiety, ICD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FF EMDR | Experimental | Behavioral: Flashforward EMDRSubjects in this group will receive two EMDR treatment sessions following the flashforward protocol. |
| FB EMDR | Active comparator | Behavioral: Flashback EMDRSubjects in this group will receive two EMDR treatment sessions following the flashback protocol. |
| Control group | No intervention | –Subjects in this group will not receive any treatment until the wait list period (4 weeks) is over |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subjects have an ICD;
- subjects have clinical anxiety symptoms related to their ICD.
Key exclusion criteria (2 listed)
- insufficient knowledge on Dutch or English language;
- severe psychiatric disorders that warrant (other) psychiatric first, such as suicidality or psychotic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flashforward EMDRThe Flashforward procedure in EMDR-treatment aims to reduce fear evoked by images of imagined future adverse events. | Behavioural | FF EMDR |
| Flashback EMDRThe Flashback procedure in EMDR-treatment aims to successfuly process the memories of traumatic events that happened in the past. | Behavioural | FB EMDR |
Primary outcome
Cardiac Anxiety Questionnaire (CAQ)
Time frame: 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)
Self-report questionnaire to asses heart focussed anxiety
4 secondary outcomes
PTSD Check-List (PCL-5)
Time frame: Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
General Anxiety Questionnaire (GAD-7)
Time frame: Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
EuroQol (EQ5D-5L)
Time frame: Baseline (Before treatment T0) and after the second treatment session T2 (for wait list after 4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No. Data will be available, anonymized, to other researchers, upon reasonable request.
Related trials for Anxiety and Fear
Recruiting
Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis
Knee Osteoarthritis
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Not yet recruiting
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Fear of Childbirth, Mandala Coloring
Not yet recruitingPhase 2
Psilocybin FCR Early-Stage Breast Cancer
Early-stage Breast Cancer, Fear of Cancer Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Flashforward EMDR and Flashback EMDR in people with Anxiety and Fear, run by Erasmus Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leonieke Kranenburg, PhD (+31654276606, l.kranenburg@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Anxiety Questionnaire (CAQ) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.