An Individual-specific Synchrony Signature

NCT ID: NCT06749392

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-22
• Study Completion Date: 2030-03-30

Brief Summary

This study aims to establish synchrony as an individual-specific mechanism of therapeutic change and offers novel insights into the mechanisms of curative interpersonal processes. The study identifies individual-specific trait-like synchrony signature and investigates the associations between synchrony signature, the individual's trait-like characteristics, and mental health, among participants diagnosed with Major Depressive Disorder. The study further investigates how deterministic the trait-like synchrony signature is by identifying for whom, how, and when changes are anticipated. Additionally, it examines whether synchrony signature transfers to relationships with the therapist, whether and how it changes throughout treatment, and whether such potential changes are associated with improvements in mental health. Synchrony is recognized as a key driver of collaborative, affiliative, and curative relationships. While its potential role in improving mental health through interpersonal relationships has sparked growing interest, particularly in psychotherapy, the field is at a crossroads, with mixed findings challenging the widespread theoretical assumption that "more synchrony is better." This study introduces a personalized framework that emphasizes individual-specific synchrony signatures, shifting from generalized assumptions to tailored understanding and interventions. The study explores how synchrony can transform relationships into curative ones by leveraging individual-tailored changes in synchrony signatures in psychotherapy. The potential impact is vast. Tailoring synchrony to individual-specific signatures represents a paradigm shift from a one-size-fits-all approach to personalized interventions. This personalized framework could revolutionize mental health care by facilitating the development of targeted strategies that enhance treatment outcomes.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Supportive-expressive psychotherapy

Participants will receive supportive-expressive therapy for depressive disorder for 16 weeks.

Group Type: EXPERIMENTAL

Supportive-expressive treatment

Intervention Type: BEHAVIORAL

Sixteen weeks of a time-limited psychodynamic therapy adapted for depression that includes the use of expressive techniques, such as interpretation, confrontation, clarification and the use of supportive techniques, such as affirmation and empathic validation. This treatment postulates insight as its core mechanism of change.

Waiting list

Participants will wait for treatment for 16 weeks. After the waiting the participants will receive in a supportive-expressive treatment for depressive disorder for 16 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supportive-expressive treatment

Sixteen weeks of a time-limited psychodynamic therapy adapted for depression that includes the use of expressive techniques, such as interpretation, confrontation, clarification and the use of supportive techniques, such as affirmation and empathic validation. This treatment postulates insight as its core mechanism of change.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Current major depressive disorder based on the Diagnostic and Statistical Manual of Mental Disorders-5, and scores above 14 on the 17-item Hamilton rating scale for depression at two consecutive assessments, one week apart.
• For participants using psychiatric medication, the dosage must be stable for at least three months before the beginning of the study, and they will be asked to maintain stable dosage during the treatment
• Age between 18 and 65 years
• Hebrew language proficiency
• Provision of written informed consent.

Exclusion Criteria

• Current risk of suicide or self-harm
• Current substance abuse disorders
• Current or past schizophrenia or psychosis, bipolar disorder, or severe eating disorder requiring medical monitoring
• History of organic mental disease
• Currently in psychotherapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Sigal Zilcha Mano

Full professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Haifa

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sigal Zilcha-Mano

Role: CONTACT

sigalzil@gmail.com

972-8249047

Michal Malka

Role: CONTACT

mi770543@gmail.com

Facility Contacts

Sigal Zilcha Mano, Professor

Role: primary

sigalzil@gmail.com

Michal Malka, PhD

Role: backup

mi770543@gmail.com

0543363061

References

Zilcha-Mano S, Bouknik Y, Malka M, Krasovsky T. An individual-specific understanding of how synchrony becomes curative: study protocol. BMC Psychiatry. 2025 Jun 6;25(1):587. doi: 10.1186/s12888-025-06539-3.

Reference Type: DERIVED

PMID: 40481468 (View on PubMed)

Other Identifiers

101123661

Identifier Type: -

Identifier Source: org_study_id