Insomnia Disorder Clinical Trial
Official title:
Mental Imagery and Targeted Memory Reactivation in Insomnia
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00821041 -
Internet-based Treatment for Chronic Insomnia
|
Phase 2 | |
Completed |
NCT03727438 -
Provider Supported Self-Help Cognitive Behavioral Therapy for Insomnia (Tele-Self CBTI)
|
N/A | |
Recruiting |
NCT03633305 -
Optimization of Insomnia Treatment in Primary Care
|
N/A | |
Completed |
NCT04616157 -
Internet-based Cognitive Behavioral Therapy for Adolescents With Sleep Problems- a Feasibility Trial
|
N/A | |
Completed |
NCT03679884 -
Study to Assess the Long Term Safety and Tolerability of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
|
Phase 3 | |
Completed |
NCT02839200 -
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
|
Phase 2 | |
Recruiting |
NCT04752254 -
Investigating Racing Thoughts in Patients With Insomnia Disorder
|
||
Completed |
NCT05558865 -
Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)
|
N/A | |
Completed |
NCT05541055 -
Digital CBT-I for Insomnia Disorder
|
N/A | |
Active, not recruiting |
NCT06393504 -
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)
|
||
Completed |
NCT02841709 -
Efficacy and Safety of ACT-541468 in Elderly Subjects With Insomnia Disorder
|
Phase 2 | |
Completed |
NCT03328585 -
Telemedicine vs. In-person Delivery of Cognitive Behavioral Treatment of Insomnia: a Mixed Methods Analysis
|
N/A | |
Completed |
NCT02952820 -
Long-term Study of Lemborexant in Insomnia Disorder (SUNRISE 2)
|
Phase 3 | |
Recruiting |
NCT05408078 -
Become Your Own SLEEPexpert: a Behavioral Treatment Program for Insomnia in Patients With Psychiatric Disorders
|
N/A | |
Recruiting |
NCT05780983 -
Sleep Well 24 (SWELL24) Healthy Sleep-Wake Behaviors in Older Adults
|
N/A | |
Completed |
NCT03575104 -
Study to Assess the Efficacy and Safety of ACT-541468 (Daridorexant) in Adult and Elderly Subjects Suffering From Difficulties to Sleep
|
Phase 3 | |
Not yet recruiting |
NCT06279286 -
Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder
|
Phase 1/Phase 2 | |
Terminated |
NCT02571595 -
A Sleep Program to Improve Sleep Quality in People With HIV
|
N/A | |
Completed |
NCT00984698 -
A Trial of Group Psychotherapy for Veterans and Military Personnel With Post Traumatic Stress Disorder (PTSD)
|
N/A | |
Recruiting |
NCT05780177 -
Brief Behavioral Treatment for Insomnia in Veterans With Posttraumatic Stress Disorder
|
N/A |