An Individual-specific Synchrony Signature

NCT06749392 | Recruiting DMC

• 1 other identifier: 101123661
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Keywords

Synchrony; Therapeutic relationship; Trait-like; State-like; Multi-modal; Mechanisms of change

Outcome Measures

Primary Outcomes (1)

• Weekly change in Hamilton rating scale for depression (HRSD)

  A 17-item clinically administered measure assessing the severity of depression. Each item is rated on a scale ranging from 0 (don't have) to 4 (sever) or 0 (don't have) to 2 (sever). The total score ranges between 0 and 52, where higher scores indicate worse outcome.

  Measured at baseline and every week for 16 weeks of treatment

Secondary Outcomes (5)

• Weekly change in Beck Depression Inventory (BDI)

  Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.

• Weekly change in Outcome Questionnaire (OQ)

  Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.

• Trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)

  Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.

• Experiences in Close Relationships Questionnaire (ECR)

  Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.

• Trajectories of change in Inventory of Interpersonal Problems (IIP-32)

  Measured at baseline, six times during the treatment (weeks 1, 2, 4, 8, 12, 16), then once a month for four months and follow up after a year.

Study Arms (2)

Supportive-expressive psychotherapy

EXPERIMENTAL

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

Behavioral: Supportive-expressive treatment

Waiting list

NO INTERVENTION

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.

Interventions

Supportive-expressive treatment 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.

Supportive-expressive psychotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

University of Haifa

Haifa, 3498838, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 40481468 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Sigal Zilcha-Mano

CONTACT

972-8249047; sigalzil@gmail.com

Michal Malka

CONTACT

mi770543@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: November 22, 2025
• Primary Completion (Estimated): March 30, 2030
• Study Completion (Estimated): March 30, 2030
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)