An interventional study of Psychotherapy in Major Depressive Disorder, sponsored by University of Haifa. Completed at 1 site in Israel. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by University of Haifa · Not applicable, Interventional, and Basic science
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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 21 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University of Haifa is the lead sponsor of 101 studies on the registry; 25 are open to participants now.
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Exclusion Criteria:
The group underwent 16 sessions of supportive-expressive psychotherapy (Luborsky et al., 1995)
Behavioral: Psychotherapy
see group description
Change from baseline depression
A t-test will examine whether participants' scores on the Hamilton depression interview (Hamilton, 1967) have been reduced.
Time frame: Weeks 1,18
Plan to share: Yes — Numerical questionnaire data, hormone levels and fNIRS recordings will be made available to other researchers.
Supporting information: Study protocol, Sap, Analytic code
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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University of Haifa