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Набор скоро начнётся NCT07627139

Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students

Без фазы С лечением Anxiety Depression Stress (Psychology) Rumination

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: The Art of Letting Go - How to Stop Rumination | Book 1, Anchored | Book 2.
Кому может быть актуально
Состояния в реестре: Anxiety, Depression, Stress (Psychology), Rumination. Базовые параметры: 18 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effects of a Metacognitive Bibliotherapy Intervention on Anxiety, Depression, and Metacognitions Among University Students: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if a self-help reading program, called metacognitive bibliotherapy, can reduce anxiety and depression in university students studying medicine and health sciences. It will also examine whether the program changes unhelpful thinking patterns about worry and rumination. The main questions it aims to answer are: Does metacognitive bibliotherapy lower anxiety and depression symptoms in university students? Does it reduce unhelpful thinking patterns, such as excessive worry and rumination? Researchers will compare two different self-help books with a waiting list group to see if reading these books helps reduce anxiety and depression. Participants will: * Be randomly assigned to one of three groups: read The Art of Letting Go - How to Stop Rumination, read Anchored: How to Befriend Your Nervous System Using Polyvagal Theory, or join a waiting list * Read the assigned book at their own pace over 8 weeks * Complete online questionnaires at the start of the study, after 4 weeks, and after 8 weeks * Participants in the waiting list group will receive both books for free after the 8-week study period ends

Подробное описание

Background and Rationale Medical and health sciences students represent a high-risk subgroup for anxiety and depressive symptoms due to intense academic demands and clinical responsibilities. Current literature indicates that the Cognitive Attentional Syndrome (CAS) - a transdiagnostic mechanism encompassing perseverative worry, rumination, threat monitoring, and maladaptive coping strategies - plays a central mediating role in the transition from academic stress to clinical psychopathology. Low-intensity, structured self-help bibliotherapy offers an accessible, cost-effective, and scalable intervention that may support self-regulation capacity in at-risk student populations.

Objective This randomized controlled trial aims to evaluate the therapeutic efficacy of structured bibliotherapy on anxiety, depression, and metacognitive beliefs in university students studying medicine and health sciences.

Study Design

A three-arm randomized controlled trial will be conducted with 110 participants. Sample size was determined through G\*Power analysis (α = 0.05, power = 80%), with at least 30 participants per group and an allowance for dropout. Participants will be allocated to one of three groups using computer-based block randomization:

Group 1: Receives the self-help book "The Art of Letting Go - How to Stop Rumination" as a structured, low-intensity bibliotherapy material Group 2: Receives the self-help book "Anchored: How to Befriend Your Nervous System Using Polyvagal Theory" as a structured, low-intensity bibliotherapy material Waiting List Control Group: Receives no intervention during the study period; after the 8-week data collection is complete, participants may obtain both self-help books free of charge.

Participants and Setting The study population consists of students enrolled in health sciences programs at Istanbul Nişantaşı University. Participants will be recruited through voluntary convenience sampling.

Inclusion Criteria: Active enrollment in the specified faculties; voluntary informed consent.

Exclusion Criteria: Currently receiving active psychiatric treatment (psychotherapy or pharmacotherapy); change in psychopharmacological medication within the past 6 months; prior reading of the study books; presence of acute psychotic symptoms or suicidal risk.

Intervention Participants in the experimental groups receive the assigned book free of charge and are asked to read it at their own pace over an 8-week guided bibliotherapy period.

Outcome Measures

Data will be collected via online self-report questionnaires at three time points: baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8). The following validated instruments will be used:

Cognitive Attentional Syndrome Scale (CAS-1): to assess perseverative thinking and threat monitoring

Metacognitions Questionnaire-30 (MCQ-30): to evaluate metacognitive beliefs

Depression Anxiety Stress Scales-21 (DASS-21): to measure the severity of depression, anxiety, and stress symptoms

Statistical Analysis Data will be analyzed using repeated measures ANOVA to examine between-group differences and within-group changes over time. Intent-to-treat principles will be applied to address missing data.

Ethical Considerations The study was approved by the Istanbul Nişantaşı University Health Sciences Ethics Committee (Approval No: 2026.04.10, dated 14.04.2026). All participants will provide digital informed consent and may withdraw at any time without consequence. Participant data will be anonymized and stored securely. Participants showing high-risk indicators will be referred to appropriate psychological support services.

Вмешательства

  • Поведенческое The Art of Letting Go - How to Stop Rumination | Book 1
    A structured, low-intensity self-help reading program. Participants assigned to Experimental Group 1 receive this self-help book free of charge and read it at their own pace over an 8-week guided bibliotherapy period.
  • Поведенческое Anchored | Book 2
    A structured, low-intensity self-help reading program. Participants assigned to Group 2 receive this self-help book free of charge and read it at their own pace over an 8-week guided bibliotherapy period.

Первичные конечные точки

  • Change in Depression, Anxiety, and Stress Symptoms (DASS-21) [Срок оценки: Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)]
  • Change in Metacognitive Beliefs (MCQ-30) [Срок оценки: Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)]
Вторичные конечные точки (1)
  • Change in Cognitive Attentional Syndrome (CAS-1) [Срок оценки: Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)]

Критерии участия

Критерии включения

  • Active enrollment in the Faculties of Medicine, Nursing, Pharmacy, Dentistry, or Psychology at Istanbul Nisantasi University
  • Aged between 18 and 25 years
  • Provision of voluntary digital informed consent

Критерии исключения

  • Currently receiving active psychiatric treatment (psychotherapy or pharmacotherapy)
  • Change in psychopharmacological medication within the past 6 months
  • Prior reading of either of the study books
  • Presence of acute psychotic symptoms or suicidal risk

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07627139 · 2026.04.10 · 2026.04.10

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗