NCT05336734

Brief Summary

The study aims to examine inter-brain synchrony between patients and therapists over the course of psychotherapy. Eight patients underwent a 6-session course of psychotherapy for test anxiety including Cognitive Behavioral Therapy (CBT) and imagery work, following an existing protocol (see Prinz et al., 2019), as well as a pre- and post- treatment interview (with different interviewers). The researchers used functional near-infrared spectroscopy (fNIRS) imaging to record brain activity during both interviews and sessions 1, 3, and 5, and collected saliva samples to measure hormone 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, that synchrony in the pre-treatment interview will be lower than in the post-treatment interview, and that synchrony would be correlated with increases in Oxytocin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2022

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 6, 2022

Last Update Submit

April 13, 2022

Conditions

Keywords

SynchronyfNIRSimagingpsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline State Test Anxiety

    A six-item self-report questionnaire designed to measure test anxiety, evaluation apprehension and low efficacy (Lawrence \& Williams, 2013). Change was defined as the difference between State Test Anxiety at week 7 and at week 2, and a successful outcome would be State Test Anxiety being lower at week 7 than at week 2. The scale is comprised of 6 items scored between 0 and 6, with the scale value being the mean of the items and as such also ranging between 0 and 6, with higher values representing more anxiety (i.e., more symptoms).

    Weeks 2,7

Secondary Outcomes (1)

  • Change from baseline Test Anxiety Inventory

    Weeks 1,8

Other Outcomes (1)

  • Change from baseline Outcome Rating Scale

    Weeks 2,7

Study Arms (1)

Main group

EXPERIMENTAL

The group underwent a psychotherapy course combining CBT and imagery work. (For full protocol see Prinz et al., 2019)

Behavioral: Psychotherapy

Interventions

PsychotherapyBEHAVIORAL

see group description

Main group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Test Anxiety Inventory at least 50.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, 3498838, Israel

Location

Related Publications (3)

  • Prinz JN, Bar-Kalifa E, Rafaeli E, Sened H, Lutz W. Imagery-based treatment for test anxiety: A multiple-baseline open trial. J Affect Disord. 2019 Feb 1;244:187-195. doi: 10.1016/j.jad.2018.10.091. Epub 2018 Oct 6.

    PMID: 30343122BACKGROUND
  • Spielberger, C.D. Test anxiety inventory: Preliminary professional manual. Palo Alto,CA: Consulting Psychologist Press. 1980.

    BACKGROUND
  • Lawrence, J. S., & Williams, A. Anxiety explains why people with domain-contingent self-worth underperform on ability-diagnostic tests. Journal of Research in Personality. 2013; 47(3): 227-232

    BACKGROUND

MeSH Terms

Interventions

Psychotherapy

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
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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2022

First Posted

April 20, 2022

Study Start

May 23, 2021

Primary Completion

January 16, 2022

Study Completion

January 16, 2022

Last Updated

April 20, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Numerical questionnaire data, hormone levels and fNIRS recordings will be made available to other researchers.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After publication.
Access Criteria
Open Access

Locations