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Inter-Brain Synchrony in Psychotherapy for Depression

Inter-Brain Synchrony in Psychotherapy for Depression

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06196346
Acronym
IBSPD
Enrollment
21
Registered
2024-01-09
Start date
2021-11-23
Completion date
2024-09-19
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Synchrony, fNIRS, Imaging, Psychotherapy

Brief summary

The study aims to examine inter-brain synchrony between patients and therapists over the course of psychotherapy. Twenty patients will undergo a 16-session course of psychotherapy for major depressive disorder. The protocol used will be supportive-expressive psychotherapy (see Luborsky et al., 1995). Participants will also undergo Hamilton depression interviews a week before treatment, before every session and a week after treatment. functional near-infrared spectroscopy (fNIRS) imaging will be used to record brain activity during every other session (sessions 1, 3, 5, 7, 9, 11, 13, 15) as well as during interviews at baseline, on session 8 and at followup. Saliva samples will be collected during the same sessions to measure hormone and cytokine levels during the same sessions. Participants completed questionnaires before and after the study, and before and after each session. The researchers hypothesized that synchrony will gradually increase over the psychotherapy sessions, and that synchrony in the pre-treatment interview will be lower than in the post-treatment interview.

Detailed description

This study centers on a 16-session supportive-expressive treatment protocol for major depression (Luborsky et al., 1995). The study will last 18 weeks. On weeks 1 and 18 participants will come in to a screening interview preformed by a research assistant. On weeks 2-17 participants will come in to therapy meetings, according to the aforementioned protocol. Every week prior to screening / treatment participants will also undergo a Hamilton depression interview. On weeks 1,2,4,6,8,9,10,12,14,16,18 the researchers will also perform functional near-infrared spectroscopy (fNIRS) imaging and take saliva samples (on weeks 1,9, and 18 - during the Hamilton interview. On other weeks - during treatment). Participants, interviewers (when interviews were assessed) and therapists (when treatment was assessed) underwent fNIRS imaging and provided saliva samples to measure Oxytocin, Cortisol and Cytokine levels. Samples will be tested for levels and subsequently destroyed. All therapists will be licensed psychologists, and will performing a brief version of Supportive-Expressive therapy (Luborsky et al., 1995). Therapists have all undergone specific training in Supportive-Expressive therapy before being involved in the study. They will also have a group supervision meeting once every two weeks with a therapist who is highly experienced in Supportive-Expressive therapy. Participants will also complete self-report questionnaires - for some of the questionnaires they may be given the option to complete them online outside of the weekly meeting itself.

Interventions

BEHAVIORALPsychotherapy

see group description

Sponsors

Society for the Advancement of Psychotherapy
CollaboratorUNKNOWN
University of Haifa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

There was no assignment to different groups and as a result, no masking.

Intervention model description

The study was designed to examine changes in inter-brain synchrony over the course of standard psychotherapy, and not treatment effectiveness. As such, a single group design was deemed adequate.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* : (a) meeting MDD diagnostic criteria using the DIAMOND structured clinical interviews for DSM-V, and scoring more than 8 on the 17-item Hamilton Rating Scale for Depression (HRSD; Hamilton, 1967) at two evaluations, one week apart; (b) if on medication, patients' dosage must be stable for at least three months before the study, and they must be willing to maintain stable dosage for the duration of treatment; (c) age between 18 and 70; (d) Hebrew language fluency; (e) provision of written informed consent.

Exclusion criteria

* (a) HRSD suicide item \> 2; (b) current substance abuse disorders; (c) current or past schizophrenia or psychosis, bipolar disorder, or severe eating disorder requiring medical monitoring; (d) history of organic mental disease (but having ADHD will not disqualify participants); (e) currently in psychotherapy.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline depressionWeeks 1,18A t-test will examine whether participants' scores on the Hamilton depression interview (Hamilton, 1967) have been reduced.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026