Clinical Trials Directory

Trials / Completed

CompletedNCT07180290

Evaluation of the ChronoS Therapy on the Severity of Sleep Disturbances Among Patients With Mood Disorders: A Within-subjects Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
67 (actual)
Sponsor
Centre Hospitalier St Anne · Academic / Other
Sex
All
Age
18 Years – 99 Years
Healthy volunteers
Not accepted

Summary

A new psychotherapy has been developed within the Psychiatry, Sleep and Chronobiology Reference Center (ChronoS) since January 2022.Results have shown relevant clinical interest on insomnia symptoms, as well on mood, anxiety and hypervigilance, according to the observation of the center's team (nurses, psychologists, psychiatrists and somnologist) In order to evaluate the effectiveness of this psychotherapy, the investigators would like to carry a multimodal approach on the severity of insomnia in patients with mood disorders.

Detailed description

Insomnia affects 85% of patients with a mood disorder during depressive phases and more than 50% will suffer from insomnia symptoms after remission. The treatment of insomnia with mood disorders represents a major therapeutic issue.European recommendations suggest that cognitive behavioural therapy for insomnia (iCBT) as the first-line reference treatment for chronic insomnia disorder. However, only 38% of patients respond positively to the treatment at 24 months, while 50% of patients with insomnia disorder and mood disorder do not respond to the treatment. The two main reasons are reported : 1\) insomnia often hide circadian disruption, or 2) patients often-present states of emotional dysregulation known as hyperarousal or hyperarousal, which result in a partial response to treatment. A new psychotherapy was developed within the Psychiatry, Sleep and Chronobiology Reference Center (ChronoS) integrating: 1. Interpersonal and Social Rhythm Therapy 2. Chronotherapies to regulate sleep/wake cycles 3. Positive mental imagery for stress management 4. Mindfulness therapy for both stress and hyperarousal state management iCBT is also adapted to a certain extent to sleep restriction to avoid sleep deprivation which is strongly linked to relapse in bipolar disorders. This psychotherapy is being practiced within the Psychiatry, Sleep and Chronobiology Reference Center (ChronoS) since January 2022, and results have shown relevant clinical interest on insomnia symptoms, as well as on mood, anxiety and hypervigilance, according to the observation of the team center (nurses, psychologists, psychiatrists and somnologist) Thus, the investigators wish to carry out a before/after study to evaluate the effectiveness of this psychotherapy with multimodal approaches on the severity of insomnia in patients with mood disorders.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPsychotherapySession 1 : Introduction and awareness of the sleep-wake link Session 2 : Awareness of day/night habits and behaviors Session 3 : Awareness of sleep/wake rhythms and sleepiness signals Session 4 : Awareness of the night/bed/sleep association Session 5 : Awareness of emotions and thoughts related to sleep Session 6 : Awareness of possible alternatives Session 7 : Awareness of one's relationship to sleep Session 8 : Awareness of future benefits

Timeline

Start date
2023-04-30
Primary completion
2024-12-30
Completion
2025-03-30
First posted
2025-09-18
Last updated
2025-09-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT07180290. Inclusion in this directory is not an endorsement.