NCT Number: NCT07627139
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
Trial opening soon.
Get Notified18 year–25 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)
Depression, anxiety, and stress symptom severity will be measured using the Depression Anxiety Stress Scales-21 (DASS-21), a validated self-report instrument. Higher scores indicate greater symptom severity. Change will be assessed across the three measurement points.
Time frame: Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)
Metacognitive beliefs will be measured using the Metacognitions Questionnaire-30 (MCQ-30), a validated self-report instrument. Higher scores indicate stronger maladaptive metacognitive beliefs. Change will be assessed across the three measurement points.
Time frame: Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)
The Cognitive Attentional Syndrome Scale (CAS-1) will be used to assess perseverative thinking (worry and rumination), threat monitoring, and maladaptive coping strategies. Higher scores indicate greater engagement in the cognitive attentional syndrome. Change will be assessed across the three measurement points.
Contact information is provided by the study sponsor or research team.
Istanbul Nisantasi University
Other
The Effects of a Metacognitive Bibliotherapy Intervention on Anxiety, Depression, and Metacognitions Among University Students: A Randomized Controlled Trial
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