- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT05336734
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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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 .
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Haifa, Israel, 3498838
- University of Haifa
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Perustiede
- Jako: Ei käytössä
- Inventiomalli: Yksittäinen ryhmätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Main group
The group underwent a psychotherapy course combining CBT and imagery work.
(For full protocol see Prinz et al., 2019)
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katso ryhmän kuvaus
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change from baseline State Test Anxiety
Aikaikkuna: Weeks 2,7
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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).
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Weeks 2,7
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change from baseline Test Anxiety Inventory
Aikaikkuna: Weeks 1,8
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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).
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Weeks 1,8
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change from baseline Outcome Rating Scale
Aikaikkuna: Weeks 2,7
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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.
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Weeks 2,7
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Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 185/21
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ANALYTIC_CODE
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