- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05933109
Mental Imagery and Targeted Memory Reactivation in PTSD
March 2, 2026 updated by: Lampros Perogamvros, University Hospital, Geneva
Augmentation of Imagery Rehearsal Therapy With Targeted Memory Reactivation for Post-Traumatic Stress Disorder (PTSD)
With this protocol, investigators examine whether targeted memory reactivation (TMR), a technique used to strengthen memories, can accelerate remission of traumatic nightmares and post-traumatic stress disorder (PTSD) symptomatology.
This protocol uses TMR during REM sleep to strengthen positive memories generated by Imagery Rehearsal Therapy (IRT), a recommended treatment of nightmares.
Patients with PTSD are asked to perform 3 weekly IRT sessions and, while they generate a positive outcome of their recurrent nightmare, half of the patients are exposed to a sound S1 (TMR group), while the other half is not exposed to this sound (control group).
All patients will perform IRT every evening at home and will be exposed to the sound S1 during REM sleep with a wireless headband, which automatically detects sleep stages.
Clinical evaluation of the severity of PTSD and nightmares before and after (1-month follow-up and 3-months follow-up) this intervention takes place using the validated Clinically Administered PTSD Scale for DSM-5 (CAPS-5, primary outcome measure).
The investigators hypothesize that patients treated with IRT and who are exposed, during REM sleep to a sound that had previously been associated with the new positive dream scenario of IRT (TMR group), will have more reduced frequency of PTSD severity and nightmares compared to participants with stimulation of the same, but non-associated, sound during REM sleep (control group).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Geneva, Switzerland
- Center for Sleep Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- with untreated persistent PTSD according to DSM-5 (> 1 month), suffering from chronic nightmares
- with no active specific treatment for PTSD
Exclusion Criteria:
- patients with active specific treatment for PTSD
- patients with neurological disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TMR group
Patients will receive a sound S1 while they generate a positive outcome of imagery rehearsal therapy (IRT).
They will also receive the sound S1 during REM sleep.
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Emerging evidence shows that REM sleep plays a causal role in extinction learning, emotion regulation and consolidation of emotionally positive memories.
By using targeted memory reactivation (TMR), a known method where a sound S1 is associated with a waking experience (i.e., a positive outcome of imagery rehearsal therapy in this study) and strengthening it during REM sleep, the investigators want to accelerate the remission of traumatic nightmares and PTSD symptomatology.
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Active Comparator: Control group
Patients will not receive the sound S1 while they generate a positive outcome of imagery rehearsal therapy (IRT).
During REM sleep, they will receive the same sound as the experimental group (S1) under the same conditions.
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These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without association with the sound S1.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician-Administered PTSD Scale for DSM-5
Time Frame: 1 month
|
Validated questionnaire that assesses PTSD symptoms, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.
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1 month
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Clinician-Administered PTSD Scale for DSM-5
Time Frame: 3 months
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Validated questionnaire that assesses PTSD symptoms, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.
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3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nightmare Frequency
Time Frame: 1 month
|
Number of nightmares per week
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1 month
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Nightmare Frequency
Time Frame: 3 months
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Number of nightmares per week
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3 months
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Positive emotions in dreams
Time Frame: 1 month
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Use of a dream diary
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1 month
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Positive emotions in dreams
Time Frame: 3 months
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Use of a dream diary
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3 months
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Nightmare Distress Questionnaire
Time Frame: 1 month
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Validated self-report scale to assess the emotional disturbance attributed to the nightmares, the score ranges from 0-52, zero indicating no symptom severity and 52 indicating the higher symptom severity.
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1 month
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Nightmare Distress Questionnaire
Time Frame: 3 months
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Validated self-report scale to assess the emotional disturbance attributed to the nightmares, the score ranges from 0-52, zero indicating no symptom severity and 52 indicating the higher symptom severity.
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3 months
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PTSD Checklist for DSM5
Time Frame: 1 month
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Validated self-report measure of PTSD, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.
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1 month
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PTSD Checklist for DSM5
Time Frame: 3 months
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Validated self-report measure of PTSD, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.
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3 months
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Beck Depression Inventory
Time Frame: 1 month
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Validated self-report scale to assess depressive symptoms, the score ranges from 0-63, zero indicating no symptom severity and 63 indicating the higher symptom severity.
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1 month
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Beck Depression Inventory
Time Frame: 3 months
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Validated self-report scale to assess depressive symptoms, the score ranges from 0-63, zero indicating no symptom severity and 63 indicating the higher symptom severity.
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3 months
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Pittsburgh Sleep Quality Index
Time Frame: 1 month
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Validated self-report scale to assess the quality of sleep, the score ranges from 0-21, zero indicating no symptom severity and 21 indicating the higher symptom severity.
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1 month
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Pittsburgh Sleep Quality Index
Time Frame: 3 months
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Validated self-report scale to assess the quality of sleep, the score ranges from 0-21, zero indicating no symptom severity and 21 indicating the higher symptom severity.
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3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sleep efficiency
Time Frame: 1 month
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The ratio between total sleep time and total bed time
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1 month
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REM arousal index
Time Frame: 1 month
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The ratio between number of arousals in stage REM x 60 and REM duration
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1 month
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Arousal index
Time Frame: 1 month
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The ratio between number of arousals in sleep x 60 and sleep duration
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1 month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2023
Primary Completion (Actual)
July 27, 2025
Study Completion (Actual)
October 27, 2025
Study Registration Dates
First Submitted
June 20, 2023
First Submitted That Met QC Criteria
June 27, 2023
First Posted (Actual)
July 6, 2023
Study Record Updates
Last Update Posted (Actual)
March 4, 2026
Last Update Submitted That Met QC Criteria
March 2, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-02270_TR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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