Major Depressive DisorderSynSigNCT06749392
An Individual-specific Synchrony Signature
A study testing Supportive-expressive treatment in people with Major Depressive Disorder, run by University of Haifa at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Supportive-expressive treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Nov 2025to 30 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michal Malka contact
Israel1 site, 1 recruiting
- Recruiting
University of Haifa
Haifa, 3498838
Sigal Zilcha Mano, Professor, sigalzil@gmail.com
Michal Malka, PhD, 0543363061, mi770543@gmail.com
About this study
Official title: 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Supportive-expressive treatment
- Keywords
- Synchrony, Therapeutic relationship, Trait-like, State-like, Multi-modal, Mechanisms of change
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive-expressive treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Supportive-expressive psychotherapy | Experimental | Participants will receive supportive-expressive therapy for depressive disorder for 16 weeks. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at baseline and every week for 16 weeks of treatment
Secondary outcomes (5)
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.
Measured: 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)
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: 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)
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: 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)
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: 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)
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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start22 Nov 2025
- Primary completion30 Mar 2030 (estimated)
- Study completion30 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sigal Zilcha Mano, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749392
- Sponsor's protocol ID
- 101123661
- Acronym
- SynSig
- Status last verified
- Nov 2025
- First submitted
- 19 Dec 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared due to ethical reasons.
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Individual-specific Understanding of How Synchrony Becomes Curative
- ClinicalTrials.gov ID
- NCT06749392
- Acronym / sponsor ID
- SynSig / 101123661
- Conditions
- Major Depressive Disorder
- Keywords
- Synchrony, Therapeutic relationship, Trait-like, State-like, Multi-modal, Mechanisms of change
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- 30 Mar 2030 (estimated)
- Study completion
- 30 Mar 2030 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Supportive-expressive psychotherapy | Experimental | Behavioral: Supportive-expressive treatmentParticipants will receive supportive-expressive therapy for depressive disorder for 16 weeks. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive-expressive treatmentSixteen 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. | Behavioural | Supportive-expressive psychotherapy |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 40481468Zilcha-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.
- Individual participant dataSharing planned: No. Data will not be shared due to ethical reasons.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michal Malka contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive-expressive treatment in people with Major Depressive Disorder, run by University of Haifa at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sigal Zilcha-Mano (972-8249047, sigalzil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly change in Hamilton rating scale for depression (HRSD) (time frame: Measured at baseline and every week for 16 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06749392, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.