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临床试验/NCT07627139
NCT07627139尚未招募不适用

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

Istanbul Nisantasi University0 个研究点目标入组 110 人开始时间: 2026年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
110

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究者

发起方
Istanbul Nisantasi University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alişan Burak Yaşar

Associate Professor

Istanbul Nisantasi University

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