Mental Imagery and Targeted Memory Reactivation in PTSD
Augmentation of Imagery Rehearsal Therapy With Targeted Memory Reactivation for Post-Traumatic Stress Disorder (PTSD)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Lampros Perogamvros
- Phone Number: +41223729952
- Email: lampros.perogamvros@hcuge.ch
Study Locations
-
-
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Geneva, Switzerland
- Center for Sleep Medicine
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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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
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
|
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
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nightmare Frequency
Time Frame: 1 month
|
Number of nightmares per week
|
1 month
|
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Nightmare Frequency
Time Frame: 3 months
|
Number of nightmares per week
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3 months
|
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Positive emotions in dreams
Time Frame: 1 month
|
Use of a dream diary
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1 month
|
|
Positive emotions in dreams
Time Frame: 3 months
|
Use of a dream diary
|
3 months
|
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Nightmare Distress Questionnaire
Time Frame: 1 month
|
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.
|
1 month
|
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Nightmare Distress Questionnaire
Time Frame: 3 months
|
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
|
Validated self-report measure of PTSD, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.
|
3 months
|
|
Beck Depression Inventory
Time Frame: 1 month
|
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.
|
1 month
|
|
Beck Depression Inventory
Time Frame: 3 months
|
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.
|
3 months
|
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Pittsburgh Sleep Quality Index
Time Frame: 1 month
|
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
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep efficiency
Time Frame: 1 month
|
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2019-02270_TR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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