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RecruitingNCT06749392SynSigUpdated Nov 24, 2025

An Individual-specific Synchrony Signature

An interventional study of Supportive-expressive treatment in Major Depressive Disorder, sponsored by University of Haifa. Recruiting at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-24.

Sponsored by University of Haifa · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Synchrony
  • Therapeutic relationship
  • Trait-like
  • State-like
  • Multi-modal
  • Mechanisms of change
03

In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.

This study's planned enrollment of 78 is close to the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

University of Haifa is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    Supportive-expressive psychotherapy

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

    Behavioral: Supportive-expressive treatment

  • 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.

Interventions

  • BehavioralSupportive-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.

06

What researchers measure

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.

    Time frame: Measured at baseline and every week for 16 weeks of treatment

Secondary outcomes

  1. Weekly change in Beck Depression Inventory (BDI)

    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.

    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.

  2. Weekly change in Outcome Questionnaire (OQ)

    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.

    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.

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

    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.

    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.

  4. Experiences in Close Relationships Questionnaire (ECR)

    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.

    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.

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

    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.

    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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 40481468 ↗

Individual participant data

Plan to share: No — Data will not be shared due to ethical reasons.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06749392
Lead sponsor
University of Haifa
Responsible party
Sigal Zilcha Mano (Full professor, University of Haifa) — Principal investigator
First posted
Dec 27, 2024
Start date
Nov 22, 2025
Primary completion
Mar 30, 2030 (estimated)
Completion
Mar 30, 2030 (estimated)
Last update
Nov 24, 2025

Study contacts

Sigal Zilcha-Mano
Contact
sigalzil@gmail.com
972-8249047
Michal Malka
Contact
mi770543@gmail.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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