Insomnia Related to Another Mental ConditionPREDI-CHRONOSNCT07202338
Association Between the Quality of the Therapeutic Alliance and the Response to ChronoS Therapy
A study testing CHRONOS therapy in people with Insomnia Related to Another Mental Condition, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
PREDI-CHRONOS is an ancillary study of the CHRONOS project (NCT07180290) The goal of this study is to measure the association between therapeutic alliance and the clinical response to the CHRONOS therapy. The CHRONOS therapy is a new psychotherapy integrating: 1. Interpersonal and Social Rhythm Therapy 2. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Insomnia Related to Another Mental Condition
- What is being tested?
- CHRONOS therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2024to 21 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 18 years old with mood disorders diagnosed according to DSM-5 criteria
- Patients with insomnia based on a ISI score >= 8
Who cannot join
- Patients < 18 years old
- Patients with psychotic disorders
- Patients who have previously received cognitive therapy for insomnia
- Patient subject to protective measures (curatorship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Quality of the Therapeutic Alliance Associated With the Response to ChronoS Therapy? A Study in Patients With Mood Disorders
PREDI-CHRONOS is an ancillary study of the CHRONOS project (NCT07180290) The goal of this study is to measure the association between therapeutic alliance and the clinical response to the CHRONOS therapy.
The CHRONOS therapy is a new psychotherapy integrating:
Read more
- 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 This therapy applied to patients with mood disorders (uni- or bipolar disorder). All participants in the study underwent the therapy. Response was defined as an improvement in the Insomnia Severity Index (ISI) from baseline to the end of the study.
The aim is to study the association of the therapeutic alliance with the response to the CHRONOS therapy, using the working alliance inventory (WAI) questionnaire.
Secondary objectives were to identify other factors potentially associated with the response to the therapy: history of a trauma, emotional regulation, and time perspective.
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.
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 The investigators designed a "before/after" study to evaluate the effectiveness of this psychotherapy with multimodal approaches on the severity of insomnia in patients with mood disorders (CHRONOS study, NCT07180290).
PREDI-CHRONOS is an ancillary study aiming at evaluating the association between therapeutic alliance and the clinical response to the CHRONOS therapy. Therapeutic alliance (or working alliance) can be defined as the collaborative relationship between patient and therapist based on purposeful collaboration and an affective bond. It is known to play an important role in therapeutic progress and treatment success.
Population: PREDI-CHRONOS included all patients that underwent the CHRONOS therapy (patients >= 18 years old, with mood disorders and an Insomnia Index Score >= 8, indicating the presence of insomnia). Patients under protection measures (curatorship) were not included in the study.
Main objective: to measure the correlation between the therapeutic alliance and the response to the CHRONOS therapy. Response was defined as an improvement in the Insomnia Severity Index (ISI) from baseline to the end of the study. Therapeutic alliance was measured using the Working Alliance Inventory (WAI) questionnaire.
Secondary objectives: to identify other factors potentially associated with the response to the therapy: history of a trauma, emotional regulation, and time perspective.
PREDI-CHRONOS design is similar as CHRONOS study, a first visit (V0) was scheduled before the start of the CHRONOS therapy (pre-intervention measures), then two visits at the beginning (V1) and the end (V2) of the therapy, and a final one 3 months after the end of the therapy (post-intervention measures).
Some data collected for CHRONOS study were used to characterise patients on other factors (anxiety and depressive symptoms, etc.).
- Being tested
- CHRONOS therapy
- Keywords
- Insomnia, Mood disorders, therapeutic alliance
- 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.
CHRONOS therapyBehavioural
Description: 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 |
|---|---|---|
| CHRONOS therapy | Experimental | Not described Receives: Behavioral: CHRONOS therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to CHRONOS therapy
Response to therapy was measured by the Insomnia Severity Index (ISI). The score ranging from 17 to 84. A score above 7 indicating the presence of insomnia (score between 8-14 = insomnia symptoms of mild to moderate severity; score between 15-21 = insomnia symptoms of moderate severity; score between 22-28 = severe insomnia symptoms) An improvement in the ISI score between the beginning and the end of the therapy was considered as an effective response
Measured: Visit 1 : 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of the CHRONOS therapy (8 weeks after V1)
Evaulation of therapeutic alliance
Therapeutic alliance was measured using the Working Alliance Inventory Short Revised (WAI-SR), a 12-item form, and scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance.
Measured: Visit 1: 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2: last session of the CHRONOS therapy (8 weeks after V1)
Secondary outcomes (5)
Presence of a trauma
The Adversed Childhood Experiences (ACE) questionnaire is a 10-item self-report tool, which is a count of the total number of adverse events respondents reported.
Measured: Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion)
Emotional regulation
Questionnaires Difficulties in Emotion Regulation Scale (DERS). A total score is calculated by summing the item responses and ranges from 18 to 90; higher scores indicate greater difficulty with emotion regulation.
Measured: Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of CHRONOS therapy (8 weeks after V1)
Time perspective
Zimbardo Time Perspective Inventory (ZTPI). The questionnaire distinguished five time perspectives (past-negative, past-positive, present-hedonistic, present-fatalistic, and future). Well-being was reflected by a balanced time perspective (BTP). Deviation from the balanced time perspective is defined as a Euclidean distance between optimal (o) and empirical (e) levels of time perspectives.
Results showed that balanced time perspective is associated with greater past positive (PP) and future (F) and lower past negative (PN) and present fatalistic (PF) time perspectives.
Measured: Visit 1: 1st session of CHRONOS therapy (4 to 6 weeks after inclusion)
Presence of a trauma
PTSD Checklist for DSM-5 (PCL-5): Several criteria (exposition to a traumatic vent, re-experienced traumatic event, negative thoughts, etc.) allow to identify posttraumatic stress disorder among adults. All of the criteria are required for the diagnosis of PTSD.
Measured: Visit 1: 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion)
Emotional regulation
Emotion regulation questionnaire (ERQ). Respondents' answers are scored on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree). The scoring takes the average of all the scores in each subscale. A higher score indicate greater use of emotion regulation strategy.
Measured: Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of CHRONOS therapy (8 weeks after V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start24 Jul 2024
- Primary completion21 Apr 2025
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia Related to Another Mental ConditionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Before/after study
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202338
- Sponsor's protocol ID
- D22_EPI0028_B
- Acronym
- PREDI-CHRONOS
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Quality of the Therapeutic Alliance Associated With the Response to ChronoS Therapy? A Study in Patients With Mood Disorders
- ClinicalTrials.gov ID
- NCT07202338
- Acronym / sponsor ID
- PREDI-CHRONOS / D22_EPI0028_B
- Keywords
- Insomnia, Mood disorders, therapeutic alliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 1 Oct 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.
PREDI-CHRONOS is an ancillary study of the CHRONOS project (NCT07180290) The goal of this study is to measure the association between therapeutic alliance and the clinical response to the CHRONOS therapy.
The CHRONOS therapy is a new psychotherapy 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 This therapy applied to patients with mood disorders (uni- or bipolar disorder). All participants in the study underwent the therapy. Response was defined as an improvement in the Insomnia Severity Index (ISI) from baseline to the end of the study.
The aim is to study the association of the therapeutic alliance with the response to the CHRONOS therapy, using the working alliance inventory (WAI) questionnaire.
Secondary objectives were to identify other factors potentially associated with the response to the therapy: history of a trauma, emotional regulation, and time perspective.
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.
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 The investigators designed a "before/after" study to evaluate the effectiveness of this psychotherapy with multimodal approaches on the severity of insomnia in patients with mood disorders (CHRONOS study, NCT07180290).
PREDI-CHRONOS is an ancillary study aiming at evaluating the association between therapeutic alliance and the clinical response to the CHRONOS therapy. Therapeutic alliance (or working alliance) can be defined as the collaborative relationship between patient and therapist based on purposeful collaboration and an affective bond. It is known to play an important role in therapeutic progress and treatment success.
Population: PREDI-CHRONOS included all patients that underwent the CHRONOS therapy (patients >= 18 years old, with mood disorders and an Insomnia Index Score >= 8, indicating the presence of insomnia). Patients under protection measures (curatorship) were not included in the study.
Main objective: to measure the correlation between the therapeutic alliance and the response to the CHRONOS therapy. Response was defined as an improvement in the Insomnia Severity Index (ISI) from baseline to the end of the study. Therapeutic alliance was measured using the Working Alliance Inventory (WAI) questionnaire.
Secondary objectives: to identify other factors potentially associated with the response to the therapy: history of a trauma, emotional regulation, and time perspective.
PREDI-CHRONOS design is similar as CHRONOS study, a first visit (V0) was scheduled before the start of the CHRONOS therapy (pre-intervention measures), then two visits at the beginning (V1) and the end (V2) of the therapy, and a final one 3 months after the end of the therapy (post-intervention measures).
Some data collected for CHRONOS study were used to characterise patients on other factors (anxiety and depressive symptoms, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before/after study
| Arm | Type | Receives |
|---|---|---|
| CHRONOS therapy | Experimental | Behavioral: CHRONOS therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years old with mood disorders diagnosed according to DSM-5 criteria
- Patients with insomnia based on a ISI score >= 8
Key exclusion criteria (4 listed)
- Patients < 18 years old
- Patients with psychotic disorders
- Patients who have previously received cognitive therapy for insomnia
- Patient subject to protective measures (curatorship)
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 |
|---|---|---|
| CHRONOS therapyDescription: 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 | Behavioural | CHRONOS therapy |
Primary outcome
Response to CHRONOS therapy
Time frame: Visit 1 : 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of the CHRONOS therapy (8 weeks after V1)
Response to therapy was measured by the Insomnia Severity Index (ISI). The score ranging from 17 to 84. A score above 7 indicating the presence of insomnia (score between 8-14 = insomnia symptoms of mild to moderate severity; score between 15-21 = insomnia symptoms of moderate severity; score between 22-28 = severe insomnia symptoms) An improvement in the ISI score between the beginning and the end of the therapy was considered as an effective response
Evaulation of therapeutic alliance
Time frame: Visit 1: 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2: last session of the CHRONOS therapy (8 weeks after V1)
Therapeutic alliance was measured using the Working Alliance Inventory Short Revised (WAI-SR), a 12-item form, and scores ranging from 5 to 20. Higher scores indicate a better therapeutic alliance.
5 secondary outcomes
Presence of a trauma
Time frame: Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion)
Emotional regulation
Time frame: Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of CHRONOS therapy (8 weeks after V1)
Time perspective
Time frame: Visit 1: 1st session of CHRONOS therapy (4 to 6 weeks after inclusion)
Presence of a trauma
Time frame: Visit 1: 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion)
Emotional regulation
Time frame: Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of CHRONOS therapy (8 weeks after V1)
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 1 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHRONOS therapy in people with Insomnia Related to Another Mental Condition, 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 2 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 1 Oct 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?
Response to CHRONOS therapy (time frame: Visit 1 : 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of the CHRONOS therapy (8 weeks after V1)). The study lists 2 primary outcomes in all. 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 1 Oct 2025.