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

Centre Hospitalier St Anne67 enrolled

Overview

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: 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

Allocation

RANDOMIZED

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Insomnia Severity Index (ISI)

brief self report questionnaire to assess the severity of insomnia cases

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

Secondary Outcomes

Seasonal Pattern Assessment Questionnaire (SPAQ)

questionnaire to evaluate seasonal effects on mood and behavior

Morningness-Eveningness Questionnaire (MEQ)

Scale used to evaluate chronotype

The Berlin Questionnaire

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

Pittsburgh Sleep Quality Index

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

The Epworth Sleepiness Scale (ESS)

self-administered questionnaire used by doctors to assess daytime sleepiness

The Disturbing Dream and Nightmare Severity Index (DDNSI)

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

Wakefulness after sleep onset (WASO)

measurement used to assess a person's sleep

A sleep fragmentation index (SFI)

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

Sleep efficiency (SE)

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

Hyperarousal Scale (HAS)

self-report of symptoms initially described in insomnia patients

The Hospital Anxiety and Depression Scale (HADS)

Scale used to assess anxiety and depression symptoms in patients

Quick Inventory of Depressive Symptomatology (QIDS)

brief self report tool used to evaluation the symptoms of depression

Generalized Anxiety Disorder 7 (GAD-7)

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

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

Multidimensional Assessment of Thymic States) (MATHYS)

scale used to define mood states dimensionally

Young Mania Rating Scale (YMRS)

rating scales to assess manic symptoms

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

Scale used to quantify the severity of suicidal ideation and behavior

Consumption of self medicated sleeping pills

type,dosage, frequency of consumption of sleeping pills

Psychotropic treatment

frequency and impact of psychotropic treatment

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes