NCT07627139

Brief Summary

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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
5mo left

Started Jun 2026

Shorter than P25 for not_applicable anxiety

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Last Updated

June 4, 2026

Status Verified

May 1, 2026

Enrollment Period

4 months

First QC Date

May 30, 2026

Last Update Submit

May 30, 2026

Conditions

Keywords

MetacognitionPsychological Distressself-helprumination

Outcome Measures

Primary Outcomes (2)

  • Change in Depression, Anxiety, and Stress Symptoms (DASS-21)

    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)

    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 Outcomes (1)

  • Change in Cognitive Attentional Syndrome (CAS-1)

    Baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8)

Study Arms (3)

Bibliotherapy - Group 1

EXPERIMENTAL

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

Waiting List Control

NO INTERVENTION

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.

Bibliotherapy - Group 2

EXPERIMENTAL

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

Interventions

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.

Bibliotherapy - Group 1

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.

Bibliotherapy - Group 2

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersDepressionRumination Syndrome

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Central Study Contacts

Alişan Burak Yaşar, MD, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Three-arm parallel-group randomized controlled trial comparing two metacognitive bibliotherapy interventions with a waiting list control. Participants are randomly assigned to one of three groups using computer-based block randomization and remain in their assigned group throughout the 8-week intervention period. Outcomes are assessed at baseline (Week 0), mid-intervention (Week 4), and post-intervention (Week 8).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 30, 2026

First Posted

June 4, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Last Updated

June 4, 2026

Record last verified: 2026-05