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

NCT ID: NCT07202338

Last Updated: 2025-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-24
• Study Completion Date: 2025-04-21

Brief 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.

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:

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 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.).

Conditions

Insomnia Related to Another Mental Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CHRONOS therapy

Group Type: EXPERIMENTAL

CHRONOS therapy

Intervention Type: BEHAVIORAL

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

Interventions

CHRONOS therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GHU Paris Psychiatrie et Neurosciences

Paris, , France

Countries

France

Other Identifiers

D22_EPI0028_B

Identifier Type: -

Identifier Source: org_study_id