Inter-Brain Synchrony in Psychotherapy for Depression (IBSPD)

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Psychotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 3498838
    • University of Haifa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Main group; The group underwent 16 sessions of supportive-expressive psychotherapy (Luborsky et al., 1995)	Behavioral: Psychotherapy; see group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline depression	A t-test will examine whether participants' scores on the Hamilton depression interview (Hamilton, 1967) have been reduced.	Weeks 1,18

Collaborators and Investigators

• Sponsor: University of Haifa
• Collaborators: Society for the Advancement of Psychotherapy

Publications and helpful links

General Publications

• Hamilton M. Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol. 1967 Dec;6(4):278-96. doi: 10.1111/j.2044-8260.1967.tb00530.x. No abstract available.
• Luborsky, L., Mark, D., Hole, A. V., Popp, C., Goldsmith, B., & Cacciola, J. (1995). Supportive-expressive dynamic psychotherapy of depression: A time-limited version. In J. P. Barber & P. Crits-Christoph (Eds.), Dynamic therapies for psychiatric disorders (Axis I) (pp. 13-42). Basic Books.

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2021
• Primary Completion (Actual): September 19, 2024
• Study Completion (Actual): September 19, 2024

Study Registration Dates

• First Submitted: December 25, 2023
• First Submitted That Met QC Criteria: December 25, 2023
• First Posted (Actual): January 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; fNIRS; Psychotherapy; Synchrony
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 047/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Numerical questionnaire data, hormone levels and fNIRS recordings will be made available to other researchers.
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Open access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No