Insomnia Due to Mental DisorderCRHONOSNCT07180290
Evaluation of the ChronoS Therapy on the Severity of Sleep Disturbances Among Patients With Mood Disorders: A Within-subjects Study
A study testing Psychotherapy in people with Insomnia Due to Mental Disorder, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Insomnia Due to Mental Disorder
- What is being tested?
- Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 30 Apr 2023to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the 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 :
- 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.
- Conditions
- Insomnia Due to Mental Disorder
- Being tested
- Psychotherapy
- Keywords
- Insomnia, Mood disorders
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
brief self report questionnaire to assess the severity of insomnia cases
Measured: 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)
questionnaire to evaluate seasonal effects on mood and behavior
Measured: 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)
Scale used to evaluate chronotype
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start30 Apr 2023
- Primary completion30 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Due to Mental DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Alexis GEOFFROY, Professor of psychiatry, Study director, GHU Paris Psychiatrie et Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180290
- Sponsor's protocol ID
- D22_EPI0028
- Acronym
- CRHONOS
- Status last verified
- Sep 2025
- First submitted
- 31 Jan 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the ChronoS Therapy on the Severity of Sleep Disturbances Among Patients With Mood Disorders: A Within-subjects Study
- ClinicalTrials.gov ID
- NCT07180290
- Acronym / sponsor ID
- CRHONOS / D22_EPI0028
- Conditions
- Insomnia Due to Mental Disorder
- Keywords
- Insomnia, Mood disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 30 Apr 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar disorder | Experimental | Behavioral: PsychotherapyBipolar 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. |
| Unipolar disorder | Experimental | Behavioral: PsychotherapyUnipolar 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychotherapySession 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 | Behavioural | Bipolar disorder, Unipolar disorder |
Primary outcome
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
19 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Alexis GEOFFROY, Professor of psychiatry study director
GHU Paris Psychiatrie et Neurosciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy in people with Insomnia Due to Mental Disorder, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.