Clinical trial NCT06749392: An Individual-specific Synchrony Signature
Official title: An Individual-specific Understanding of How Synchrony Becomes Curative
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Synchrony
Therapeutic relationship
Trait-like
State-like
Multi-modal
Mechanisms of change
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weekly change in Hamilton rating scale for depression (HRSD)
timeFrame: Measured at baseline and every week for 16 weeks of treatment
Secondary outcomes:
measure: Weekly change in Beck Depression Inventory (BDI)
timeFrame: Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.
measure: Weekly change in Outcome Questionnaire (OQ)
timeFrame: Measured at baseline, every week for 16 weeks of treatment, then once a month for four months and follow up after a year.
measure: Trajectories of change in Quality of Life Enjoyment and Satisfaction- Short Version (Q-LES-Q)
timeFrame: 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.
measure: Experiences in Close Relationships Questionnaire (ECR)
timeFrame: 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.
measure: Trajectories of change in Inventory of Interpersonal Problems (IIP-32)
timeFrame: 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.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
References: