Mental Imagery and Targeted Memory Reactivation in Insomnia

University Hospitals (UH)

Status: Enrolling

Conditions: Insomnia Disorder

Treatments: Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention; Behavioral: Sleep Hygiene + Odor; Behavioral: Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep; Behavioral: Imagery Rescripting (IR); Behavioral: Sleep Hygiene

Study type: Interventional

Funder types: Other

Identifiers

NCT06335784

2023-00456

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Sleep Hygiene (SH)

Active Comparator group

Description:

Participants 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.

Treatment:

Behavioral: Sleep Hygiene

Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention

Imagery Rescripting (IR)

Experimental group

Description:

Participants 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.

Treatment:

Behavioral: Imagery Rescripting (IR)

Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention

Targeted Memory Reactivation (TMR)

Experimental group

Description:

Participants 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.

Treatment:

Behavioral: Imagery Rescripting (IR) and Targeted Memory Reactivation (TMR) during sleep

Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention

Odor Alone (OA)

Active Comparator group

Description:

Participants 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.

Treatment:

Behavioral: Sleep Hygiene + Odor

Other: "Rocking bed" if patients still have insomnia complaints (ISI >10) after the 4 weeks of the intervention