Mental Imagery and Targeted Memory Reactivation in PTSD

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933109
• Other study ID #: 2019-02270_TR
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: July 2023
• Source: University Hospital, Geneva
• Contact: Lampros Perogamvros
• Phone: +41223729952
• Email: lampros.perogamvros[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Nightmares, REM-Sleep Type
• PTSD

Intervention

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

Locations

Country	Name	City	State
Switzerland	Center for Sleep Medicine	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep efficiency	The ratio between total sleep time and total bed time	1 month
Other	REM arousal index	The ratio between number of arousals in stage REM x 60 and REM duration	1 month
Other	Arousal index	The ratio between number of arousals in sleep x 60 and sleep duration	1 month
Primary	Clinician-Administered PTSD Scale for DSM-5	Validated questionnaire that assesses PTSD symptoms, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.	1 month
Primary	Clinician-Administered PTSD Scale for DSM-5	Validated questionnaire that assesses PTSD symptoms, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.	3 months
Secondary	Nightmare Frequency	Number of nightmares per week	1 month
Secondary	Nightmare Frequency	Number of nightmares per week	3 months
Secondary	Nightmare Distress Questionnaire	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
Secondary	Nightmare Distress Questionnaire	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.	3 months
Secondary	Positive emotions in dreams	Use of a dream diary	1 month
Secondary	Positive emotions in dreams	Use of a dream diary	3 months
Secondary	PTSD Checklist for DSM5	Validated self-report measure of PTSD, the score ranges from 0-80, zero indicating no symptom severity and 80 indicating the higher symptom severity.	1 month
Secondary	PTSD Checklist for DSM5	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
Secondary	Beck Depression Inventory	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
Secondary	Beck Depression Inventory	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
Secondary	Pittsburgh Sleep Quality Index	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.	1 month
Secondary	Pittsburgh Sleep Quality Index	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.	3 months