An Individual-specific Synchrony Signature (SynSig)

November 21, 2025 updated by: Sigal Zilcha Mano, University of Haifa

An Individual-specific Understanding of How Synchrony Becomes Curative

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supportive-expressive psychotherapy
Participants will receive supportive-expressive therapy for depressive disorder for 16 weeks.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly change in Hamilton rating scale for depression (HRSD)
Time Frame: Measured at baseline and every week for 16 weeks of treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly change in Beck Depression Inventory (BDI)
Time Frame: Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.
A 21-item, self-rated scale that evaluates key symptoms of depression. Each item is rated on a scale ranging from 0 (don't have) to 3 (sever). The total score ranges between 0 and 63, where higher scores indicate worse outcome.
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)
Time Frame: Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.
A 30 items self-report measure designed to assess patient therapy outcomes on three primary dimensions: (a) subjective discomfort, (b) interpersonal relationships, and (c) social role performance. Each item is rated on a scale ranging from 0 (never) to 4 (almost always). The total score ranges between 0 and 120, where higher scores indicate worse outcome.
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)
Time Frame: 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.
A 16-item self report measure designed to assess quality of life enjoyment and satisfaction. Each item is rated on a scale ranging from 1 (not at all) to 5 (extremely). The total score ranges between 16 and 80, where higher scores indicate better outcome.
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)
Time Frame: 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.
A 36-item self-report measure designed to assess adult attachment styles. The measurement data will be aggregated into two sub-scales: anxiety and avoidance. Each item is rated on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). The total score on each subscale ranges between 18 and 126, where higher scores indicate worse outcome.
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)
Time Frame: 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.
A 32-item self-report measure designed to assess interpersonal problems. Each item is rated in terms of how distressing the problem is for the individual on a scale ranging from 0 (not at all) to 4 (extremely). The total score ranges between 0 and 128, where higher scores indicate higher interpersonal problems, worse outcome.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Haifa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2025

Primary Completion (Estimated)

March 30, 2030

Study Completion (Estimated)

March 30, 2030

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101123661

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared due to ethical reasons.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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