Adult ALLMDLNCT06110702
Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms
A study testing EMDR in people with Adult ALL and Post-traumatic Stress Disorder, run by University of Pisa at 1 site in Italy.
Trial summary
The Eye Movement Desensitization and Reprocessing Protocol (EMDR) was first developed by Francine Shapiro in 1987 and can be adapted for online and in presence administration. The aim of this study is to assess if a EMDR program (administered both online and in presence, depending on different conditions of patients)… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult ALL, Post-traumatic Stress Disorder, Obsessive-Compulsive Disorder
- What is being tested?
- EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2021to 30 Apr 2022
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants aged 18 to 75 years
- Participants experienced a full COVID19 pandemic-related quarantine during red zones of the second and third lockdowns in Italy
- Participants have reasonable comprehension of spoken and written Italian language
- Participants have an adequate understanding of Italian
Who cannot join
- Concurrent enrollment in other intervention trials
- Participants that already experienced EMDR therapy in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Trial on the Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms During the COVID19 Quarantine: a Psychometric Study
The Eye Movement Desensitization and Reprocessing Protocol (EMDR) was first developed by Francine Shapiro in 1987 and can be adapted for online and in presence administration. The aim of this study is to assess if a EMDR program (administered both online and in presence, depending on different conditions of patients) may help people recruited from general population suffering from COVID19 second (November 2021 to February 2022) and third (March 2022 to May 2022) quarantine in improving post-traumatic stress (PTSD) and obsessive-compulsive-related (OCD) symptoms, as well as disgust, guilt, shame and their subjective unit of distress (SUD) and validity of cognition (VoC) levels.
- Conditions
- Adult ALL, Post-traumatic Stress Disorder, Obsessive-Compulsive Disorder, Disgust, Guilt, Shame
- Being tested
- EMDR
- Keywords
- PTSD, OCD, Disgust, Guilt, Shame, Body, EMDR
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Stress Disorders, Post-Traumatic, Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDRBehavioural
Eye movement Desensitization and Reprocessing (as described in the 8-phases protocol), administered both online or in presence.
| Study group | Role | What they receive |
|---|---|---|
| 8-week EMDR Intervention | Experimental | Phase 1: The therapist and client develop a secure working relationship. The client's history is discussed and a treatment plan is developed.
Phase 2: The therapist explains the EMDR therapy process. Phase 3: The target event is identified. Baseline measures are set using the Subjective Units of Disturbance (SUD) and the Validity of Cognition (VOC) scale.
Phase 4: Desensitization, sounds, or taps are begun while focusing on the traumatic event until the client's SUD reduces to zero.
Phase 5: The client associates and strengthens a positive belief with the target event until it feels true.
Phase 6: The client is asked to hold in mind the target event and the positive belief while scanning the body.
Phase 7: Reprocessing is complete when the client feels neutral about it (SUD=0, VOC=7), and the body is clear of disturbance.
Phase 8: The client and therapist discuss processed memories to ensure that distress is low and that the positive cognition is strong. Receives: Behavioral: EMDR |
| Control condition - No intervention | No intervention | The control group will follow routine daily activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Stress Symptoms - Pre-intervention
Post-Traumatic symptoms are measured using the Impact of Event Scale-Revised (IES-R). The scale ranges from a minimum value of 0 to a maximum value of 88. Lower Likert score means a better outcome
Measured: IES-R is measured immediately before the 8-week EMDR intervention
Obsessive-Compulsive Symptoms - Pre-intervention
Obsessive-Compulsive symptoms are measured using the Dimensional Obsessive-Compulsive Scale (DOCS). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Measured: DOCS is measured immediately before the 8-week EMDR intervention
Body Perception - Pre-intervention
Body Perception is measured using the Body Perception Questionnaire-22 (BPQ-22). The scale ranges from a minimum value of 22 to a maximum value of 66. Lower Likert score means a better outcome
Measured: BPQ-22 is measured immediately before the 8-week EMDR intervention
Guilt and Shame - Pre-intervention
Guilt and Shame are measured using the Guilt and Shame Proneness Scale (GASP). The scale ranges from a minimum value of 16 to a maximum value of 112. Lower Likert score means a better outcome
Measured: GASP is measured immediately before the 8-week EMDR intervention
Disgust - Pre-intervention
Disgust is measured using the Three Domain of Disgust Scale (TDDS). The scale ranges from a minimum value of 0 to a maximum value of 126. Lower Likert score means a better outcome
Measured: TDDS is measured immediately before the 8-week EMDR intervention
Mental Contamination - Pre-intervention
Mental Contamination is measured using the Vancouver Obsessional Compulsive Inventory-Mental Contamination scale (VOCI-MC). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Measured: VOCI-MC is measured immediately before the 8-week EMDR intervention
Post-Traumatic Stress Symptoms - Post-intervention
Post-Traumatic symptoms are measured using the Impact of Event Scale-Revised (IES-R). The scale ranges from a minimum value of 0 to a maximum value of 88. Lower Likert score means a better outcome
Measured: IES-R is measured immediately after the 8-week EMDR intervention
Obsessive-Compulsive Symptoms - Post-intervention
Obsessive-Compulsive symptoms are measured using the Dimensional Obsessive-Compulsive Scale (DOCS). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Measured: DOCS is measured immediately after the 8-week EMDR intervention
Body Perception - Post-intervention
Body Perception is measured using the Body Perception Questionnaire-22 (BPQ-22). The scale ranges from a minimum value of 22 to a maximum value of 66. Lower Likert score means a better outcome
Measured: BPQ-22 is measured immediately after the 8-week EMDR intervention
Guilt and Shame - Post-intervention
Guilt and Shame are measured using the Guilt and Shame Proneness Scale (GASP). The scale ranges from a minimum value of 16 to a maximum value of 112. Lower Likert score means a better outcome
Measured: GASP is measured immediately after the 8-week EMDR intervention
Disgust - Post-intervention
Disgust is measured using the Three Domain of Disgust Scale (TDDS). The scale ranges from a minimum value of 0 to a maximum value of 126. Lower Likert score means a better outcome
Measured: TDDS is measured immediately after the 8-week EMDR intervention
Mental Contamination - Post-intervention
Mental Contamination is measured using the Vancouver Obsessional Compulsive Inventory-Mental Contamination scale (VOCI-MC). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Measured: VOCI-MC is measured immediately after the 8-week EMDR intervention
Secondary outcomes (6)
Anxiety Symptoms - Pre-intervention
Anxiety symptoms are measured using the Depression Anxiety Stress Scales (DASS-21).The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome
Measured: DASS-21 is measured immediately before the 8-week EMDR intervention
Depression Symptoms - Pre-intervention
Depression symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome
Measured: DASS-21 is measured immediately before the 8-week EMDR intervention
General distress symptoms - Pre-intervention
General distress symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome
Measured: DASS-21 is measured immediately before the 8-week EMDR intervention
Anxiety Symptoms - Post-intervention
Anxiety symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome
Measured: DASS-21 is measured immediately after the 8-week EMDR intervention
Depression Symptoms - Post-intervention
Depression symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome
Measured: DASS-21 is measured immediately after the 8-week EMDR intervention
General distress symptoms - Post-intervention
General distress symptoms are measured using the Depression Anxiety Stress Scales (DASS-21). The scale ranges from a minimum value of 0 to a maximum value of 63. Lower Likert score means a better outcome
Measured: DASS-21 is measured immediately after the 8-week EMDR intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start10 Oct 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adult ALLStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Poli, University of Pisa
- Investigators
- Andrea Poli, PsyD, Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110702
- Sponsor's protocol ID
- MDL-01
- Acronym
- MDL
- Status last verified
- Apr 2024
- First submitted
- 23 Oct 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data are available on request.
Publications
Miccoli M, Poli A. Randomized trial on the effects of an EMDR intervention on traumatic and obsessive symptoms during the COVID-19 quarantine: a psychometric study. Front Psychiatry. 2024 Jun 26;15:1369216. doi: 10.3389/fpsyt.2024.1369216. eCollection 2024.
PubMed 38988736
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on the Effects of an EMDR Intervention on Traumatic and Obsessive Symptoms During the COVID19 Quarantine: a Psychometric Study
- ClinicalTrials.gov ID
- NCT06110702
- Acronym / sponsor ID
- MDL / MDL-01
- Conditions
- Adult ALL, Post-traumatic Stress Disorder, Obsessive-Compulsive Disorder, Disgust, Guilt, Shame
- Keywords
- PTSD, OCD, Disgust, Guilt, Shame, Body, EMDR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 1 Nov 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 Eye Movement Desensitization and Reprocessing Protocol (EMDR) was first developed by Francine Shapiro in 1987 and can be adapted for online and in presence administration. The aim of this study is to assess if a EMDR program (administered both online and in presence, depending on different conditions of patients) may help people recruited from general population suffering from COVID19 second (November 2021 to February 2022) and third (March 2022 to May 2022) quarantine in improving post-traumatic stress (PTSD) and obsessive-compulsive-related (OCD) symptoms, as well as disgust, guilt, shame and their subjective unit of distress (SUD) and validity of cognition (VoC) levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 8-week EMDR Intervention | Experimental | Behavioral: EMDRPhase 1: The therapist and client develop a secure working relationship. The client's history is discussed and a treatment plan is developed. Phase 2: The therapist explains the EMDR therapy process. Phase 3: The target event is identified. Baseline measures are set using the Subjective Units of Disturbance (SUD) and the Validity of Cognition (VOC) scale. Phase 4: Desensitization, sounds, or taps are begun while focusing on the traumatic event until the client's SUD reduces to zero. Phase 5: The client associates and strengthens a positive belief with the target event until it feels true. Phase 6: The client is asked to hold in mind the target event and the positive belief while scanning the body. Phase 7: Reprocessing is complete when the client feels neutral about it (SUD=0, VOC=7), and the body is clear of disturbance. Phase 8: The client and therapist discuss processed memories to ensure that distress is low and that the positive cognition is strong. |
| Control condition - No intervention | No intervention | –The control group will follow routine daily activities |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants aged 18 to 75 years
- Participants experienced a full COVID19 pandemic-related quarantine during red zones of the second and third lockdowns in Italy
- Participants have reasonable comprehension of spoken and written Italian language
- Participants have an adequate understanding of Italian
Key exclusion criteria (2 listed)
- Concurrent enrollment in other intervention trials
- Participants that already experienced EMDR therapy in the past
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 |
|---|---|---|
| EMDREye movement Desensitization and Reprocessing (as described in the 8-phases protocol), administered both online or in presence. | Behavioural | 8-week EMDR Intervention |
Primary outcome
Post-Traumatic Stress Symptoms - Pre-intervention
Time frame: IES-R is measured immediately before the 8-week EMDR intervention
Post-Traumatic symptoms are measured using the Impact of Event Scale-Revised (IES-R). The scale ranges from a minimum value of 0 to a maximum value of 88. Lower Likert score means a better outcome
Obsessive-Compulsive Symptoms - Pre-intervention
Time frame: DOCS is measured immediately before the 8-week EMDR intervention
Obsessive-Compulsive symptoms are measured using the Dimensional Obsessive-Compulsive Scale (DOCS). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Body Perception - Pre-intervention
Time frame: BPQ-22 is measured immediately before the 8-week EMDR intervention
Body Perception is measured using the Body Perception Questionnaire-22 (BPQ-22). The scale ranges from a minimum value of 22 to a maximum value of 66. Lower Likert score means a better outcome
Guilt and Shame - Pre-intervention
Time frame: GASP is measured immediately before the 8-week EMDR intervention
Guilt and Shame are measured using the Guilt and Shame Proneness Scale (GASP). The scale ranges from a minimum value of 16 to a maximum value of 112. Lower Likert score means a better outcome
Disgust - Pre-intervention
Time frame: TDDS is measured immediately before the 8-week EMDR intervention
Disgust is measured using the Three Domain of Disgust Scale (TDDS). The scale ranges from a minimum value of 0 to a maximum value of 126. Lower Likert score means a better outcome
Mental Contamination - Pre-intervention
Time frame: VOCI-MC is measured immediately before the 8-week EMDR intervention
Mental Contamination is measured using the Vancouver Obsessional Compulsive Inventory-Mental Contamination scale (VOCI-MC). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Post-Traumatic Stress Symptoms - Post-intervention
Time frame: IES-R is measured immediately after the 8-week EMDR intervention
Post-Traumatic symptoms are measured using the Impact of Event Scale-Revised (IES-R). The scale ranges from a minimum value of 0 to a maximum value of 88. Lower Likert score means a better outcome
Obsessive-Compulsive Symptoms - Post-intervention
Time frame: DOCS is measured immediately after the 8-week EMDR intervention
Obsessive-Compulsive symptoms are measured using the Dimensional Obsessive-Compulsive Scale (DOCS). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
Body Perception - Post-intervention
Time frame: BPQ-22 is measured immediately after the 8-week EMDR intervention
Body Perception is measured using the Body Perception Questionnaire-22 (BPQ-22). The scale ranges from a minimum value of 22 to a maximum value of 66. Lower Likert score means a better outcome
Guilt and Shame - Post-intervention
Time frame: GASP is measured immediately after the 8-week EMDR intervention
Guilt and Shame are measured using the Guilt and Shame Proneness Scale (GASP). The scale ranges from a minimum value of 16 to a maximum value of 112. Lower Likert score means a better outcome
Disgust - Post-intervention
Time frame: TDDS is measured immediately after the 8-week EMDR intervention
Disgust is measured using the Three Domain of Disgust Scale (TDDS). The scale ranges from a minimum value of 0 to a maximum value of 126. Lower Likert score means a better outcome
Mental Contamination - Post-intervention
Time frame: VOCI-MC is measured immediately after the 8-week EMDR intervention
Mental Contamination is measured using the Vancouver Obsessional Compulsive Inventory-Mental Contamination scale (VOCI-MC). The scale ranges from a minimum value of 0 to a maximum value of 80. Lower Likert score means a better outcome
6 secondary outcomes
Anxiety Symptoms - Pre-intervention
Time frame: DASS-21 is measured immediately before the 8-week EMDR intervention
Depression Symptoms - Pre-intervention
Time frame: DASS-21 is measured immediately before the 8-week EMDR intervention
General distress symptoms - Pre-intervention
Time frame: DASS-21 is measured immediately before the 8-week EMDR intervention
Anxiety Symptoms - Post-intervention
Time frame: DASS-21 is measured immediately after the 8-week EMDR intervention
Depression Symptoms - Post-intervention
Time frame: DASS-21 is measured immediately after the 8-week EMDR intervention
General distress symptoms - Post-intervention
Time frame: DASS-21 is measured immediately after the 8-week EMDR intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 38988736Miccoli M, Poli A. Randomized trial on the effects of an EMDR intervention on traumatic and obsessive symptoms during the COVID-19 quarantine: a psychometric study. Front Psychiatry. 2024 Jun 26;15:1369216. doi: 10.3389/fpsyt.2024.1369216. eCollection 2024.
- Individual participant dataSharing planned: Yes. Raw data are available on request.
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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.
Andrea Poli, PsyD principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMDR in people with Adult ALL and Post-traumatic Stress Disorder, run by University of Pisa at 1 site in Italy.
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 4 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: finished, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Traumatic Stress Symptoms - Pre-intervention (time frame: IES-R is measured immediately before the 8-week EMDR intervention). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06110702, which also lists 1 linked publication.
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 16 Apr 2024.