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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia Due to Mental Disorder
• Intervention / Treatment: Behavioral: Psychotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Centre CHRONOS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Experimental: 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	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	brief self report questionnaire to assess the severity of insomnia cases	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seasonal Pattern Assessment Questionnaire (SPAQ)	questionnaire to evaluate seasonal effects on mood and behavior	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Morningness-Eveningness Questionnaire (MEQ)	Scale used to evaluate chronotype	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
The Berlin Questionnaire	Questionnaire used to assess the risk of developing sleep apnea syndrome.	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Pittsburgh Sleep Quality Index	self-report instrument used to evaluate posttraumatic stress disorder (PTSD)	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
The Epworth Sleepiness Scale (ESS)	self-administered questionnaire used by doctors to assess daytime sleepiness	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
The Disturbing Dream and Nightmare Severity Index (DDNSI)	self-retrospective measure of current nightmare and disturbing dream frequency and severity	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Wakefulness after sleep onset (WASO)	measurement used to assess a person's sleep	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
A sleep fragmentation index (SFI)	calculate the total number of awakenings/shifts divided by the total sleep time in hours	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Sleep efficiency (SE)	Ratio of total sleep time (TST) to time in bed (TIB), duration divided by the bed duration	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Hyperarousal Scale (HAS)	self-report of symptoms initially described in insomnia patients	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
The Hospital Anxiety and Depression Scale (HADS)	Scale used to assess anxiety and depression symptoms in patients	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Quick Inventory of Depressive Symptomatology (QIDS)	brief self report tool used to evaluation the symptoms of depression	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Generalized Anxiety Disorder 7 (GAD-7)	self-reported questionnaire for screening and severity measuring of generalized anxiety disorder	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
The Montgomery-Åsberg Depression Rating Scale (MADRS)	A 7 point scale used to measure severity of depression in individuals 18 years and older. Each item is rated on a 7-point scale	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Multidimensional Assessment of Thymic States) (MATHYS)	scale used to define mood states dimensionally	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Young Mania Rating Scale (YMRS)	rating scales to assess manic symptoms	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
The Columbia-Suicide Severity Rating Scale (C-SSRS)	Scale used to quantify the severity of suicidal ideation and behavior	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Consumption of self medicated sleeping pills	type,dosage, frequency of consumption of sleeping pills	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy
Psychotropic treatment	frequency and impact of psychotropic treatment	Baseline visit : at participants' inclusion Visit 1: alongside 1st session of the therapy Visit 2: after the 4th session of the therapy Visit 3: after the last session (8th) of the therapy Visit 4 : 3 months after the end of the therapy

Collaborators and Investigators

• Sponsor: Centre Hospitalier St Anne
• Investigators: Study Director: Pierre-Alexis GEOFFROY, Professor of psychiatry, GHU Paris Psychiatrie et Neurosciences

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2023
• Primary Completion (Actual): December 30, 2024
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: September 15, 2025
• First Posted (Estimated): September 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Insomnia; Mood disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Mood Disorders; Sleep Initiation and Maintenance Disorders; Behavioral Disciplines and Activities; Psychotherapy
• Other Study ID Numbers: D22_EPI0028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No