Mental Imagery and Targeted Memory Reactivation in PTSD

Sponsor

University Hospital, Geneva (Other)

Overall Status

Recruiting

CT.gov ID

NCT05933109

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Nightmares, REM-Sleep Type PTSD	Behavioral: Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep Behavioral: Imagery Rehearsal Therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Augmentation of Imagery Rehearsal Therapy With Targeted Memory Reactivation for Post-Traumatic Stress Disorder (PTSD)

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 1, 2025

Arms and Interventions

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.	Behavioral: Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep 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.
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.	Behavioral: Imagery Rehearsal Therapy These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without association with the sound S1.

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.

Behavioral: Imagery Rehearsal Therapy and Targeted memory reactivation during REM sleep

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.

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.

Behavioral: Imagery Rehearsal Therapy

These patients will receive the classic treatment of Imagery Rehearsal Therapy (IRT) for nightmares without association with the sound S1.

Outcome Measures

Primary Outcome Measures

Clinician-Administered PTSD Scale for DSM-5 [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.
Clinician-Administered PTSD Scale for DSM-5 [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.

Secondary Outcome Measures

Nightmare Frequency [1 month]
Number of nightmares per week
Nightmare Frequency [3 months]
Number of nightmares per week
Nightmare Distress Questionnaire [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.
Nightmare Distress Questionnaire [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.
Positive emotions in dreams [1 month]
Use of a dream diary
Positive emotions in dreams [3 months]
Use of a dream diary
PTSD Checklist for DSM5 [1 month]
Validated self-report measure of PTSD, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.
PTSD Checklist for DSM5 [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.
Beck Depression Inventory [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.
Beck Depression Inventory [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.
Pittsburgh Sleep Quality Index [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.
Pittsburgh Sleep Quality Index [3 months]
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.

Other Outcome Measures

Sleep efficiency [1 month]
The ratio between total sleep time and total bed time
REM arousal index [1 month]
The ratio between number of arousals in stage REM x 60 and REM duration
Arousal index [1 month]
The ratio between number of arousals in sleep x 60 and sleep duration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Sleep Medicine	Geneva		Switzerland

Sponsors and Collaborators

University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lampros Perogamvros, Attending Physician, University Hospital, Geneva

ClinicalTrials.gov Identifier:

NCT05933109

Other Study ID Numbers:

2019-02270_TR

First Posted:

Jul 6, 2023

Last Update Posted:

Jul 11, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 11, 2023