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Completed

NCT Number: NCT07180290

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre CHRONOS

Paris, France

About this study

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 :

  • 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:

  • Interpersonal and Social Rhythm Therapy
  • Chronotherapies to regulate sleep/wake cycles
  • Positive mental imagery for stress management
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged over 18 years old
  • Diagnosed with
  • A mood disorder (bipolar or unipolar) recognized in the DSM-5
  • 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

Treatment and study plan

Psychotherapy

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

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 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

    brief self report questionnaire to assess the severity of insomnia cases

Secondary outcomes

  1. Seasonal Pattern Assessment Questionnaire (SPAQ)

    Time frame: 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

    questionnaire to evaluate seasonal effects on mood and behavior

  2. Morningness-Eveningness Questionnaire (MEQ)

    Time frame: 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

    Scale used to evaluate chronotype

  3. The Berlin Questionnaire

    Time frame: 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

    Questionnaire used to assess the risk of developing sleep apnea syndrome.

  4. Pittsburgh Sleep Quality Index

    Time frame: 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

    self-report instrument used to evaluate posttraumatic stress disorder (PTSD)

  5. The Epworth Sleepiness Scale (ESS)

    Time frame: 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

    self-administered questionnaire used by doctors to assess daytime sleepiness

  6. The Disturbing Dream and Nightmare Severity Index (DDNSI)

    Time frame: 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

    self-retrospective measure of current nightmare and disturbing dream frequency and severity

  7. Wakefulness after sleep onset (WASO)

    Time frame: 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

    measurement used to assess a person's sleep

  8. A sleep fragmentation index (SFI)

    Time frame: 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

    calculate the total number of awakenings/shifts divided by the total sleep time in hours

  9. Sleep efficiency (SE)

    Time frame: 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

    Ratio of total sleep time (TST) to time in bed (TIB), duration divided by the bed duration

  10. Hyperarousal Scale (HAS)

    Time frame: 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

    self-report of symptoms initially described in insomnia patients

  11. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: 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

    Scale used to assess anxiety and depression symptoms in patients

  12. Quick Inventory of Depressive Symptomatology (QIDS)

    Time frame: 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

    brief self report tool used to evaluation the symptoms of depression

  13. Generalized Anxiety Disorder 7 (GAD-7)

    Time frame: 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

    self-reported questionnaire for screening and severity measuring of generalized anxiety disorder

  14. The Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 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 7 point scale used to measure severity of depression in individuals 18 years and older. Each item is rated on a 7-point scale

  15. Multidimensional Assessment of Thymic States) (MATHYS)

    Time frame: 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

    scale used to define mood states dimensionally

  16. Young Mania Rating Scale (YMRS)

    Time frame: 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

    rating scales to assess manic symptoms

  17. The Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: 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

    Scale used to quantify the severity of suicidal ideation and behavior

  18. Consumption of self medicated sleeping pills

    Time frame: 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

    type,dosage, frequency of consumption of sleeping pills

  19. Psychotropic treatment

    Time frame: 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

    frequency and impact of psychotropic treatment

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Acronym: CRHONOS

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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