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Mental Imagery and Targeted Memory Reactivation in Insomnia

ConditionInsomnia Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversity Hospital, Geneva

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 45 years

Insomnia disorder according to the International Classification of Diseases 3 (ICSD-3)

ISI > 10

PSQI > 5

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Imagery Rescripting (IR)

    Behavioral

    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.

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

    Behavioral

    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

    Behavioral

    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.

  • Sleep Hygiene + Odor

    Behavioral

    Sleep hygiene instructions will be applied in the presence of an odor, which will be also used during the night.

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

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: Sleep Hygiene (SH)Active comparator 2 interventions
Group B: Imagery Rescripting (IR)Experimental treatment 2 interventions
Group C: Targeted Memory Reactivation (TMR)Experimental treatment 2 interventions
Group D: Odor Alone (OA)Active comparator 2 interventions

Trial outcomes

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.

Time frame
Baseline, 5 Weeks and 3 Months

Secondary outcomes

1

Pittsburgh sleep quality index (PSQI)

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.

Time frame
Baseline, 5 Weeks and 3 Months
2

Total Sleep Time (TST)

Time from sleep onset to sleep offset. This outcome is measured both subjectively and objectively.

Time frame
Baseline and 5 Weeks
3

Wake After Sleep Onset (WASO)

Number of awakenings during the night. This outcome is measured both subjectively and objectively.

Time frame
Baseline and 5 Weeks
4

Beck Depression Inventory II (BDI-II)

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.

Time frame
Baseline, 5 Weeks and 3 Months

Other outcomes

1

Temperament and Character Inventory

A 240-item self-administered questionnaire designed to measure 4 temperament and 3 character scales.

Time frame
Baseline and 5 Weeks
2

Pre-sleep Arousal Scale (PSAS)

A 16-item self-reported questionnaire designed to measure pre-sleep arousability, the score ranges from 16-80, 16 indicating no symptom severity and 80 indicating the higher symptom severity.

Time frame
Baseline and 5 Weeks
3

Arousal Predisposition Scale (APS)

A 12-item self-reported questionnaire designed to measure arousability

Time frame
Baseline and 5 Weeks
4

Digit Span Task

A working memory task, asking the participant to repeat a string of numbers which are displayed verbally, exactly as given, for "digits forward," and in reverse order for "digits backward"

Time frame
Baseline and 5 Weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Geneva

Lead sponsor

University of Geneva, Switzerland

Collaborator

Source ClinicalTrials.gov
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