search
Back to results

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

Primary Purpose

Test Anxiety

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Psychotherapy
Sponsored by
University of Haifa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Test Anxiety focused on measuring Synchrony, fNIRS, imaging, psychotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Haifa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main group

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
April 6, 2022
Last Updated
April 13, 2022
Sponsor
University of Haifa
search

1. Study Identification

Unique Protocol Identification Number
NCT05336734
Brief Title
Inter-Brain Synchrony in Psychotherapy for Test Anxiety
Acronym
IBSP-TA
Official Title
Inter-Brain Synchrony in Psychotherapy for Test Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2021 (Actual)
Primary Completion Date
January 16, 2022 (Actual)
Study Completion Date
January 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Haifa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Test Anxiety
Keywords
Synchrony, fNIRS, imaging, psychotherapy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
There was no assignment to different groups and as a result, no masking.
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Main group
Arm Type
Experimental
Arm Description
The group underwent a psychotherapy course combining CBT and imagery work. (For full protocol see Prinz et al., 2019)
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy
Intervention Description
see group description
Primary Outcome Measure Information:
Title
Change from baseline State Test Anxiety
Description
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).
Time Frame
Weeks 2,7
Secondary Outcome Measure Information:
Title
Change from baseline Test Anxiety Inventory
Description
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).
Time Frame
Weeks 1,8
Other Pre-specified Outcome Measures:
Title
Change from baseline Outcome Rating Scale
Description
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.
Time Frame
Weeks 2,7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University of Haifa
City
Haifa
ZIP/Postal Code
3498838
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
30343122
Citation
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.
Results Reference
background
Citation
Spielberger, C.D. Test anxiety inventory: Preliminary professional manual. Palo Alto,CA: Consulting Psychologist Press. 1980.
Results Reference
background
Citation
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
Results Reference
background

Learn more about this trial

Inter-Brain Synchrony in Psychotherapy for Test Anxiety

We'll reach out to this number within 24 hrs