Inter-Brain Synchrony in Psychotherapy for Test Anxiety (IBSP-TA)

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.

Study Overview

• Status: Completed
• Conditions: Test Anxiety
• Intervention / Treatment: Behavioral: Psychotherapy

Detailed Description

This study centers on a short-term 6-session imagery-based treatment protocol for Test anxiety (Developed by Prof. Eshkol Rafaeli who is a collaborator on the study, with colleagues at the University of Trier; for the full protocol, see www.osf.io/hraqd). The protocol integrates traditional cognitive behavioral and imagery techniques; each session is also followed by some homework assignment, aimed at practicing the contents of the session and/or preparing for the next one.

The study lasted 8 weeks. On weeks 1 and 8 participants came in to a screening interview preformed by a research assistant. On weeks 2-7 participants came in to therapy meetings, according to the aforementioned protocol. On weeks 1,2,4,6,8 the researchers also performed functional near-infrared spectroscopy (fNIRS). imaging and took saliva samples. Participants, assessors (in assessment sessions) and therapists (in treatment sessions) underwent fNIRS imaging and provided saliva samples to measure Oxytocin and Cortisol levels. Samples were tested for hormonal levels and subsequently destroyed.

The study was an exploratory study, with the same therapist, who was a licensed clinical psychologist, treating all patients. He received supervision from an experienced psychologist with long experience employing cognitive-behavioral and experiential treatment methods.

Preliminary questionnaires. (a) Test Anxiety Inventory (b) Young Schema Questionnaire (YSQ-3) to assess early maladaptive schemas; (c) Ten Item Personality Inventory (TIPI) to assess Big-5 characteristics; (d) Schema Mode Inventory (SMI-2) to assess schema modes ; (e) Adult Attention Deficit Hyperactivity Disorder (ADHD) Self Report Scale; (f) Inventory of Interpersonal Problems (IIP) to assess interpersonal problems; (f) General Anxiety Disorder 7-item (GAD7) scale to assess anxiety symptoms; (g) Mindset questionnaire; (h) Patient Health Questionnaire (PHQ9) to assess depression symptoms; (i) Relationship Quality (RQ) to assess attachment; (j) demographic questionnaire; (k) Trauma questionnaires - The life event and Post Traumatic Stress Disorder checklists for the Diagnostic and Statistical Manual (DSM-5) and the Adverse Childhood Experiences Scale .

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Test Anxiety Inventory at least 50.

Exclusion Criteria:

• Participants with severe mood, anxiety, obsessional, psychotic, or eating disorders as assessed using a Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Neuropsychiatric Disorders (DIAMOND) interview were excluded (However, comorbid single-episode major depressive disorder or social anxiety disorder did not lead to exclusion).

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: Main group; The group underwent a psychotherapy course combining CBT and imagery work. (For full protocol see Prinz et al., 2019)	Behavioral: Psychotherapy; see group description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Test Anxiety Inventory	A 20-item questionnaire measuring test anxiety (Spielberger, 1980). Change was defined as the difference between Test Anxiety Inventory values at week 1 and at week 8, and a successful outcome would be Test Anxiety Inventory being lower at week 8 than at week 1. Each item is scored between 1 and 4 and the scale value is calculated by summing the items, such that the scale ranges between 20 and 80, with high values representing more anxiety (i.e., more symptoms).	Weeks 1,8

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Outcome Rating Scale	The Outcome Rating Scale (ORS) is a 4-item questionnaire evaluating general wellbeing (Miller et al., 2003). Change was defined as the difference between the ORS at week 7 and at week 2, and a successful outcome would be ORS at week 7 being higher than at week 2. ORS is presented as 4 visual slider items, and the scale is calculated by mapping each slider position to a number between 0 and 100 and calculating the mean of the 4 items, resulting in a scale ranging between 0 and 100 with 100 representing greater wellbeing.	Weeks 2,7

Collaborators and Investigators

• Sponsor: University of Haifa

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2021
• Primary Completion (Actual): January 16, 2022
• Study Completion (Actual): January 16, 2022

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: imaging; psychotherapy; fNIRS; Synchrony
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 185/21

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