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NCT Number: NCT07202338

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHU Paris Psychiatrie et Neurosciences

Paris, France

About this study

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.).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. Presence of a trauma

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

    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.

  2. 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)

    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.

  3. Time perspective

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

    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.

  4. Presence of a trauma

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

    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.

  5. 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)

    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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

Is the Quality of the Therapeutic Alliance Associated With the Response to ChronoS Therapy? A Study in Patients With Mood Disorders

Acronym: PREDI-CHRONOS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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