Inter-Brain Synchrony in Psychotherapy for Depression

NCT06196346 | Completed

• 1 other identifier: 047/21
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Synchrony; fNIRS; Imaging; Psychotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Experimental: Main group

EXPERIMENTAL

The group underwent 16 sessions of supportive-expressive psychotherapy (Luborsky et al., 1995)

Behavioral: Psychotherapy

Interventions

Psychotherapy BEHAVIORAL

see group description

Experimental: Main group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• : (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• University of Haifa: lead
• Society for the Advancement of Psychotherapy: collaborator

Study Sites (1)

University of Haifa

Haifa, Israel, 3498838, Israel

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 6080235 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There was no assignment to different groups and as a result, no masking.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: November 23, 2021
• Primary Completion: September 19, 2024
• Study Completion: September 19, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication
• Access Criteria: Open access

Locations

IL (1)