Insomnia Due to Mental Disorder
Conditions
Keywords
Insomnia, Mood disorders
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.
Interventions
BEHAVIORALPsychotherapy
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
Sponsors
Centre Hospitalier St Anne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Scale used to evaluate chronotype |
| 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 | Questionnaire used to assess the risk of developing sleep apnea syndrome. |
| 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 | self-report instrument used to evaluate posttraumatic stress disorder (PTSD) |
| 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 | self-administered questionnaire used by doctors to assess daytime sleepiness |
| The Disturbing Dream and Nightmare Severity Index (DDNSI) | 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 |
| Wakefulness after sleep onset (WASO) | 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 |
| A sleep fragmentation index (SFI) | 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 |
| Sleep efficiency (SE) | 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 |
| Hyperarousal Scale (HAS) | 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 |
| 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 | questionnaire to evaluate seasonal effects on mood and behavior |
| Quick Inventory of Depressive Symptomatology (QIDS) | 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 |
| Generalized Anxiety Disorder 7 (GAD-7) | 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 |
| The Montgomery-Åsberg Depression Rating Scale (MADRS) | 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 |
| Multidimensional Assessment of Thymic States) (MATHYS) | 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 |
| Young Mania Rating Scale (YMRS) | 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 |
| The Columbia-Suicide Severity Rating Scale (C-SSRS) | 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 |
| Consumption of self medicated 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 | type,dosage, frequency of consumption of sleeping pills |
| 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 | frequency and impact of psychotropic treatment |
| The Hospital Anxiety and Depression Scale (HADS) | 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 |
Countries
France
Outcome results
None listed