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

NCT ID: NCT07180290

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2025-03-30

Brief 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

Insomnia Due to Mental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bipolar disorder

Bipolar disorder is defined by the DSM-5 as the experience of episodes of depression or anhedonia (i.e., a lack of interest or pleasure in activities) and at least four additional symptoms: decreased energy; psychomotor slowing or psychomotor restlessness; changes in appetite and weight; sleep disturbance (from insomnia to hypersomnia); difficulty concentrating and/or inability to make everyday decisions; feelings of worthlessness and/or excessive guilt; and suicidal ideation and attempts.

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

Session 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

Unipolar disorder

Unipolar disorder is defined by the DSM-5 as the experience of 5 or more of the following symptoms, at least once per day, and for a period that's longer than 2 weeks:

• Sadness or irritability, lasting most of the day
• Loss of interest in the majority of activities that were enjoyable before
• Change in appetite, or sudden weight loss/gain
• Difficulty falling asleep, or wanting to sleep more than before
• Feelings of restlessness
• Lack of energy and increased tiredness
• Feelings of worthlessness or guilt, often linking to things that normally wouldn't have this kind of effect
• Difficulty concentrating, making decisions and thinking
• Suicidal or self-harming thoughts

Group Type: EXPERIMENTAL

Psychotherapy

Intervention Type: BEHAVIORAL

Session 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

Interventions

Psychotherapy

Session 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged over 18 years old
• Diagnosed with

1. A mood disorder (bipolar or unipolar) recognized in the DSM-5

2. Chronic insomnia disorder recognized in the DSM-5

• Must have obtained a score ≥ 8 on the ISI scale evaluated by the clinician, that indicates at least an insomnia of mild intensity

Exclusion Criteria

• Patients aged under 18 years old
• Patients with psychotic disorder
• Patients who have previously undergone CBT insomnia or other targeted cognitive behavioral therapy
• Patients under guardianship, curatorship or protection of the court

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre-Alexis GEOFFROY, Professor of psychiatry

Role: STUDY_DIRECTOR

GHU Paris Psychiatrie et Neurosciences

Locations

Centre CHRONOS

Paris, , France

Countries

France

Other Identifiers

D22_EPI0028

Identifier Type: -

Identifier Source: org_study_id