Mental Imagery and Targeted Memory Reactivation in Insomnia

Not Applicable

Recruiting

• Conditions: Insomnia Disorder

• Registration Number: NCT06335784
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-28
• Status Verified: 2024-04
• Study Start: 2024-04-22
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2027-05-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	Baseline, 5 Weeks and 3 Months	Standardized questionnaire that measures ID severity, the score ranges from 0-28, zero indicating no symptom severity and 28 indicating the higher symptom severity.

Secondary Outcome Measures

Name	Time	Method
Sleep efficiency (SE)	Baseline and 5 Weeks	Ratio between total time spent in bed and total sleep time. This outcome is measured both subjectively and objectively.
Total Sleep Time (TST)	Baseline and 5 Weeks	Time from sleep onset to sleep offset. This outcome is measured both subjectively and objectively.
Pittsburgh sleep quality index (PSQI)	Baseline, 5 Weeks and 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.
Wake After Sleep Onset (WASO)	Baseline and 5 Weeks	Number of awakenings during the night. This outcome is measured both subjectively and objectively.
Beck Depression Inventory II (BDI-II)	Baseline, 5 Weeks and 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.
State Trait Anxiety Inventory (STAI)	Baseline, 5 Weeks and 3 Months	Validated self-report scale to assess anxiety, the score ranges from 20-80, 20 indicating no symptom severity and 80 indicating the higher symptom severity.
Micro-arousals	Baseline and 5 Weeks	Objective measure of micro-awakenings during the night.

Trial Locations

Locations (1)

Center for Sleep Medicine; 🇨🇭 Geneva, Switzerland