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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Aged over 18 years old
Diagnosed with
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 :
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Alexis GEOFFROY, Professor of psychiatry | GHU Paris Psychiatrie et Neurosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre CHRONOS | Paris | France |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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| 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 |
| D001523 |
| Mental Disorders |