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

NCT07180290 | Completed

• 1 other identifier: D22_EPI0028
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia Due to Mental Disorder

Keywords

Insomnia; Mood disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Seasonal Pattern Assessment Questionnaire (SPAQ)

  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)

  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

  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

  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)

  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

Study Arms (2)

Bipolar disorder

EXPERIMENTAL

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

Unipolar disorder

EXPERIMENTAL

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

Interventions

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

Bipolar disorder; Unipolar disorder

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

Centre CHRONOS

Paris, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mood Disorders

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Pierre-Alexis GEOFFROY, Professor of psychiatry

  GHU Paris Psychiatrie et Neurosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: September 18, 2025
• Study Start: April 30, 2023
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

FR (1)