Mental Imagery and Targeted Memory Reactivation in Insomnia
1 other identifier
interventional
120
1 country
1
Brief Summary
In this clinical trial, the investigators test whether mental Imagery Rescripting (IR), a technique where the individual is instructed to transform a negative memory or image into a positive one, and olfactory Targeted Memory Reactivation (TMR), a technique used to strengthen memories, can reduce hyperarousal and insomnia severity in patients with Insomnia Disorder (ID). Patients with ID will be randomized into four groups: in the first group (SH group), patients will have 4 weekly sessions (1 session/week) of a minimal intervention for insomnia (sleep hygiene information) in the presence of an odorless diffuser, which will be also used during the night. In the second group (IR group), patients will use IR during wakefulness to induce a state of relaxation and positive emotionality. More specifically, during 4 weekly sessions of IR, patients will imagine a negative scenario related to their pre-sleep images or current concerns (e.g., social interactions, self-image, sleep problem, nightmares) and transform it into a positive script. They will then perform IR every day for 4 weeks at home in the presence of an odorless diffuser, which will be also used during the night. In the third group, patients will undergo the same 4 weekly IR sessions and an odor will be paired to the positive imagery and will be diffused during the night (TMR group). Patients from this group will also perform IR every day for 4 weeks at home. Finally, the fourth group (OA group) will receive 4 weekly sessions of sleep hygiene instructions in the presence of an odor, which will be also used during the night. Clinical evaluation of insomnia severity before and after the intervention will take place using the Insomnia Severity Index (ISI, primary outcome measure). At the end of these interventions, patients with persistent symptoms will benefit from an alternative experimental treatment ("rocking bed") in which they will be cradled for one night. The investigators hypothesize that patients treated with IR will have significantly reduced insomnia severity compared to participants who received a minimal intervention. They also hypothesize that patients of the TMR group, will have more reduced ID severity compared to participants performing IR and with an odorless diffuser, therefore without an association (IR group). Finally, they hypothesize that one night of sleeping in a rocking bed will improve objective measures of sleep in ID compared to a stationary condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedStudy Start
First participant enrolled
April 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
March 3, 2026
March 1, 2026
3.1 years
March 21, 2024
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index (ISI)
Standardized questionnaire that measures ID severity, the score ranges from 0-28, zero indicating no symptom severity and 28 indicating the higher symptom severity.
Baseline, 5 Weeks and 3 Months
Secondary Outcomes (7)
Pittsburgh sleep quality index (PSQI)
Baseline, 5 Weeks and 3 Months
Total Sleep Time (TST)
Baseline and 5 Weeks
Wake After Sleep Onset (WASO)
Baseline and 5 Weeks
Beck Depression Inventory II (BDI-II)
Baseline, 5 Weeks and 3 Months
State Trait Anxiety Inventory (STAI)
Baseline, 5 Weeks and 3 Months
- +2 more secondary outcomes
Other Outcomes (7)
Temperament and Character Inventory
Baseline and 5 Weeks
Pre-sleep Arousal Scale (PSAS)
Baseline and 5 Weeks
Arousal Predisposition Scale (APS)
Baseline and 5 Weeks
- +4 more other outcomes
Study Arms (4)
Sleep Hygiene (SH)
ACTIVE COMPARATORParticipants will receive 4 weekly individual sessions of standardized instructions on sleep hygiene, that they will be asked to apply every day for 4 weeks. Each session will consist of providing patients with advice to help their sleep without any CBT-I or other complementary medicine components. They will also have an odorless diffuser being diffused at the end of each weekly individual session and during the night.
Imagery Rescripting (IR)
EXPERIMENTALParticipants will receive 4 weekly individual sessions of IR. The IR technique consists of imagining a negative memory or image as vividly as possible, and of transforming it into a positive one. An odorless diffuser will be presented while imagining the positive imagery generated during IR. During 4 weeks, patients of this group will practice IR at home, every day in bed and have the same odorless diffuser being diffused during the night.
Targeted Memory Reactivation (TMR)
EXPERIMENTALParticipants will receive 4 weekly individual sessions of IR, at the end of which, a chosen odor will be presented while imagining the positive imagery generated during IR. During 4 weeks, patients of this group will practice IR at home every day in bed and have the same odor being diffused during the night.
Odor Alone (OA)
ACTIVE COMPARATORParticipants will have a chosen odor diffused during the night for 4 weeks and will receive 4 weekly individual sessions of standardized instructions on sleep hygiene, that they will be asked to apply every day for 4 weeks. The chosen odor will be diffused at the end of each weekly individual session.
Interventions
Targeted Memory Reactivation (TMR) is a technique used to strengthen a memory trace during sleep. TMR is used to modify memory formation through the application of cues during sleep. In this TMR protocol, an olfactory cue is associated with the imagery rescripting (IR) during the day, and then administered during sleep. In that way, the replay of the associated memory and its corresponding neural representation in memory networks are artificially promoted, a procedure which usually strengthens memory consolidation. Previous studies have shown that TMR in sleep reduces emotional arousal, making it a promising technique for insomnia.
Sleep hygiene instructions will be applied in the presence of an odor, which will be also used during the night.
Imagery rescripting (IR) is a technique where the individual is instructed to imagine a negative memory or image as vividly as possible, and to change it in a direction that he/she desires. IR seems particularly efficient because it is based on the experienced emotions during perceptual information processing, thereby eliciting stronger emotional responses than verbal processing.
Sleep hygiene education includes modifications in the behavior (e.g., exercise, coffee, alcohol intake) and environment (e.g., light, noise, temperature conditions) that offer to the individual the foundation for healthy sleep. Sleep hygiene is an important component in treating ID, but insufficient and less effective than CBT-I when offered alone.
Rocking stimulation boosts brain oscillations in deep sleep (i.e., sleep spindles and slow oscillations) into a rhythmic appearance supporting a neurophysiological mechanism whereby continuous rocking entrains endogenous thalamo-cortical sleep oscillations. The beneficial effects of rocking strengthening the continuity of sleep might have clinical applications and it will be of interest to evaluate if such non-pharmacological could improve sleep and reduce such features of hyperarousal in ID patients.
Eligibility Criteria
You may qualify if:
- Age between 18 and 45 years
- Insomnia disorder according to the International Classification of Diseases 3 (ICSD-3)
- ISI \> 10
- PSQI \> 5
- No other current treatment for Insomnia
You may not qualify if:
- patients with another psychiatric disorder requiring acute treatment according to DSM-5
- patients with medical (e.g. neurological disorders) or other disorders explaining the predominant complaint of insomnia (e.g., sleep apneas with ODI\>15/h, restless legs syndrome, periodic limb movements with PLM\>15, chronic pain)
- patients with significant substance use/withdrawal
- patients with heavy smoking
- known pregnancy
- patients suffering from anosmia, olfactory related issues and respiratory pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Genevalead
- University of Geneva, Switzerlandcollaborator
Study Sites (1)
Center for Sleep Medicine
Geneva, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
March 21, 2024
First Posted
March 28, 2024
Study Start
April 22, 2024
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
March 3, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share