CompletedNot Applicable

Association Between the Quality of the Therapeutic Alliance and the Response to ChronoS Therapy

France48 participantsStarted 2024-07-24

Plain-language 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. Chronotherapies to regulate sleep/wake cycles 3. Positive mental imagery for stress management 4. 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients over 18 years old with mood disorders diagnosed according to DSM-5 criteria * Patients with insomnia based on a ISI score \>= 8 Exclusion Criteria: * Patients \< 18 years old * Patients with psychotic disorders * Patients who have previously received cognitive therapy for insomnia * Patient subject to protective measures (curatorship)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Response to CHRONOS therapy

Timeframe: 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

Timeframe: 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)

Trial details

NCT IDNCT07202338

SponsorCentre Hospitalier St Anne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-21

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