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

NCT07202338 | Completed

• 1 other identifier: D22_EPI0028_B
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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. 1.Interpersonal and Social Rhythm Therapy
2. 2.Chronotherapies to regulate sleep/wake cycles
3. 3.Positive mental imagery for stress management
4. 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.

Conditions

Insomnia Related to Another Mental Condition

Keywords

Insomnia; Mood disorders; therapeutic alliance

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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

  Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion)

• Emotional regulation

  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

  Visit 1: 1st session of CHRONOS therapy (4 to 6 weeks after inclusion)

• Presence of a trauma

  Visit 1: 1st session of the CHRONOS therapy (4 to 6 weeks after inclusion)

• Emotional regulation

  Visit 1 : 1st session of CHRONOS therapy (4 to 6 weeks after inclusion) Visit 2 : last session of CHRONOS therapy (8 weeks after V1)

Study Arms (1)

CHRONOS therapy

EXPERIMENTAL

Behavioral: CHRONOS therapy

Interventions

CHRONOS therapy 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

CHRONOS therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years old with mood disorders diagnosed according to DSM-5 criteria
• Patients with insomnia based on a ISI score \>= 8

You may not qualify if:

• Patients \< 18 years old
• Patients with psychotic disorders
• Patients who have previously received cognitive therapy for insomnia
• Patient subject to protective measures (curatorship)

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris Psychiatrie et Neurosciences

Paris, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Mood Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before/after study

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: July 24, 2024
• Primary Completion: April 21, 2025
• Study Completion: April 21, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)