Inter-Brain Synchrony in Psychotherapy for Depression

Major Depressive Disorder Clinical Trial

— IBSPD  

Official title:

Inter-Brain Synchrony in Psychotherapy for Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196346
• Other study ID #: 047/21
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: University of Haifa
• Contact: Haran Sened, PhD
• Phone: 972-4-828-8778
• Email: haranse[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Psychotherapy
see group description

Locations

Country	Name	City	State
Israel	University of Haifa	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Society for the Advancement of Psychotherapy

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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