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

May 30, 2026 updated by: Alişan Burak Yaşar, Istanbul Nisantasi University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bibliotherapy - Group 1
Participants in this group receive the self-help book "The Art of Letting Go - How to Stop Rumination" as a structured, low-intensity bibliotherapy material. Participants are asked to read the book at their own pace over an 8-week guided bibliotherapy period. The book is provided free of charge.
Behavioral: 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.
No Intervention: Waiting List Control
Participants in this group receive no intervention during the 8-week study period. They complete the same online assessments at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8) as the intervention groups. After the 8-week data collection is complete, participants in this group will receive both self-help books free of charge, in accordance with the ethical principle of waiting-list compensation.
Experimental: Bibliotherapy - Group 2
Participants in this group receive the self-help book "Anchored" as a structured, low-intensity bibliotherapy material. Participants are asked to read the book at their own pace over an 8-week guided bibliotherapy period. Self-report assessments are completed at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8). The book is provided free of charge.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression, Anxiety, and Stress Symptoms (DASS-21)
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.
Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)
Change in Metacognitive Beliefs (MCQ-30)
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.
Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Attentional Syndrome (CAS-1)
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.
Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Nisantasi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

May 30, 2026

First Submitted That Met QC Criteria

May 30, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 30, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026.04.10 (Other Identifier: Istanbul Nisantasi University Health Sciences Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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