AnxietyNCT07627139
Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students
A study testing Zihninde Çok Kuran İnsanlar için Salma Rehberi and Çapa Atmak in people with Anxiety and Depression, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
Trial summary
This study tests whether reading a structured self-help book (bibliotherapy) can reduce anxiety, depression and stress and change unhelpful thinking patterns in medical and health-sciences students. Students in health programs face heavy academic and clinical demands and are at increased risk of emotional distress. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Stress (Psychology)
- What is being tested?
- Zihninde Çok Kuran İnsanlar için Salma Rehberi and Çapa Atmak
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Oct 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Currently enrolled as a student in a medicine or health-sciences program (medicine, psychology, nursing and dentistry) at İstanbul Nişantaşı University
- Sufficient proficiency in reading and understanding Turkish
- Access to an internet-connected device to complete online forms
- Electronic informed consent
Who cannot join
- Currently receiving active psychiatric treatment (psychotherapy or psychotropic medication)
- Change in psychotropic medication within the last 6 months
- Having previously read either of the study books
- Diagnosis of bipolar disorder
- Acute psychotic symptoms or current suicide risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Nişantaşı University
Istanbul, Sarıyer, 34485
About this study
Official title: The Effects of a Metacognitive Bibliotherapy Intervention on Anxiety, Depression Levels, and Metacognitions Among University Students: A Randomized Controlled Trial
This study tests whether reading a structured self-help book (bibliotherapy) can reduce anxiety, depression and stress and change unhelpful thinking patterns in medical and health-sciences students.
Students in health programs face heavy academic and clinical demands and are at increased risk of emotional distress. A thinking style called the Cognitive Attentional Syndrome (worry, rumination, threat monitoring and unhelpful coping) is thought to link stress to anxiety and depression. Metacognitive therapy targets this thinking style, and low-intensity self-help books may make these principles accessible to students.
A total of 165 students at İstanbul Nişantaşı University will be randomly assigned to one of three groups: two groups each receive a different self-help book and read it at their own pace over 8 weeks, and the third group (waitlist) receives the books after the study ends. All participants complete short online questionnaires (DASS-21, CAS-1, MCQ-30) at the start, at week 4 and at week 8, and receive brief telephone calls at weeks 2, 4 and 6 to confirm participation.
Read the detailed description
Design: Single-site, parallel-group, three-arm randomized controlled trial at İstanbul Nişantaşı University, Istanbul, Türkiye.
Participants: Students aged 18 years or older enrolled in medicine or health-sciences programs (medicine, psychology, nursing and dentistry), recruited through announcements (student WhatsApp groups, e-mail and brief in-class presentations). Participation is voluntary and has no effect on academic standing.
Arms: (1) Bibliotherapy with the self-help book "Zihninde Çok Kuran İnsanlar için Salma Rehberi"; (2) bibliotherapy with the self-help book "Çapa Atmak"; (3) waitlist control, assessment only during the study period, with books provided at the end of the study. Reading is self-paced over 8 weeks without therapist contact.
Randomization: After completion of baseline assessments, participants are allocated 1:1:1 using a computer-generated random sequence (Randomizer.org). Faculty and baseline DASS-21 total score are taken into account to support balance between groups; the DASS-21 score is not used as an inclusion threshold. The allocation list is stored securely by the research team, and allocation is not disclosed until baseline assessments are complete.
Sample size: G*Power 3.1, medium effect size (f = 0.25), three groups, α = 0.05, power 80%: minimum 159 participants. 165 participants (55 per arm) are targeted.
Measures and schedule: Sociodemographic form at baseline. Depression Anxiety Stress Scales-21 (DASS-21), Cognitive Attentional Syndrome Scale-1 (CAS-1) and Metacognitions Questionnaire-30 (MCQ-30) at week 0, week 4 and week 8, collected online through a study website after electronic informed consent. Process measures: a weekly one-item reading log in the two bibliotherapy arms, and a three-item contamination form at week 8.
Telephone contact: All participants, including the waitlist group, receive brief standardized telephone calls at weeks 2, 4 and 6 to confirm participation, reading progress and completion of forms. Calls follow a fixed script, serve reminder and confirmation purposes only, and contain no therapeutic content or guidance about the books, so that contact intensity is equal across arms.
Safety: Participants with current psychiatric treatment, a recent change in psychotropic medication, bipolar disorder, acute psychotic symptoms or suicide risk are not included. If questionnaire responses indicate a high level of distress during the study, the research team contacts the participant and refers them to appropriate mental health services.
Analysis: Repeated-measures ANOVA (or non-parametric alternatives) to examine group × time effects, with baseline scores taken into account; partial eta-squared is reported as the effect size; intention-to-treat principles are applied for missing data. SPSS is used.
Data protection: Participants are identified only by study codes. Telephone numbers are collected with consent for study contact only and stored separately from the dataset. Data are stored under encryption in accordance with Turkish personal data protection law (KVKK), and no personal identifiers appear in reports or publications.
- Conditions
- Anxiety, Depression, Stress (Psychology)
- Being tested
- Zihninde Çok Kuran İnsanlar için Salma Rehberi, Çapa Atmak
- Keywords
- Metacognition, Psychological Distress, self-help, rumination, worry
- Medical subject headings
- Anxiety Disorders, Depression, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zihninde Çok Kuran İnsanlar için Salma RehberiBehavioural
Structured self-help book based on metacognitive therapy principles, targeting the Cognitive Attentional Syndrome (worry, rumination, threat monitoring and unhelpful coping strategies). Participants read the book at their own pace over 8 weeks without therapist contact. Reading progress is recorded with a weekly one-item online reading log.
Çapa AtmakBehavioural
Self-help book read under the same conditions as Intervention 1: self-paced reading over 8 weeks without therapist contact, with a weekly one-item online reading log.
| Study group | Role | What they receive |
|---|---|---|
| Bibliotherapy - Group 1 | Experimental | Participants receive the self-help book "Zihninde Çok Kuran İnsanlar için Salma Rehberi" at study start and read it at their own pace over 8 weeks. They complete online questionnaires at weeks 0, 4 and 8, a weekly one-item reading log, and receive brief telephone calls at weeks 2, 4 and 6. Receives: Behavioral: Zihninde Çok Kuran İnsanlar için Salma Rehberi |
| Waiting List Control | No intervention | Participants complete the same online questionnaires at weeks 0, 4 and 8 and receive the same brief telephone calls at weeks 2, 4 and 6. The study books are provided after the 8-week study period. |
| Bibliotherapy - Group 2 | Experimental | Participants receive the self-help book "Çapa Atmak" at study start and read it at their own pace over 8 weeks. They complete online questionnaires at weeks 0, 4 and 8, a weekly one-item reading log, and receive brief telephone calls at weeks 2, 4 and 6. Receives: Behavioral: Çapa Atmak |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression, Anxiety, and Stress Scales (DASS-21) total score
DASS-21 (Turkish version), 21 items rated 0-3; total score is the sum of all items (range 0-63). Higher scores indicate greater psychological distress. Change from baseline to week 8 is compared between groups.
Measured: Baseline (week 0) to week 8
Secondary outcomes (3)
Change in Cognitive Attentional Syndrome Scale-1 (CAS-1) score
CAS-1 (Turkish version), 16 items. Items 1-10 (worry/rumination, threat monitoring and unhelpful coping behaviours) are rated on a 0-8 scale; items 11-16 (metacognitive beliefs) are rated on a 0-100 scale. Higher scores indicate greater Cognitive Attentional Syndrome activity.
Measured: Baseline (week 0), week 4 and week 8
Change in Metacognitions Questionnaire-30 (MCQ-30) total score
MCQ-30 (Turkish version), 30 items rated 1-4 (range 30-120). Higher scores indicate more maladaptive metacognitive beliefs.
Measured: Baseline (week 0), week 4 and week 8
Change in DASS-21 Anxiety subscale score
7 items of the DASS-21 anxiety subscale, rated 0-3 (range 0-21). Higher scores indicate more anxiety symptoms.
Measured: Baseline (week 0), week 4 and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start19 Oct 2026
- Primary completion4 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel-group randomized controlled trial: two bibliotherapy arms (two different self-help books, read over 8 weeks) and one waitlist control arm; 1:1:1 allocation.
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alişan Burak Yaşar, Istanbul Nisantasi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627139
- Sponsor's protocol ID
- 2026.19.10
- Other IDs
- 2026.19.10
- Status last verified
- Oct 2026
- First submitted
- 30 May 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the research team. This is in line with the ethics committee approval and the informed consent form, which state that data will be used only by the research team for the purposes of this study. Aggregate results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Metacognitive Bibliotherapy Intervention on Anxiety, Depression Levels, and Metacognitions Among University Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07627139
- Acronym / sponsor ID
- 2026.19.10
- Conditions
- Anxiety, Depression, Stress (Psychology)
- Keywords
- Metacognition, Psychological Distress, self-help, rumination, worry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Istanbul Nisantasi UniversityUniversity, hospital or other
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- 4 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests whether reading a structured self-help book (bibliotherapy) can reduce anxiety, depression and stress and change unhelpful thinking patterns in medical and health-sciences students.
Students in health programs face heavy academic and clinical demands and are at increased risk of emotional distress. A thinking style called the Cognitive Attentional Syndrome (worry, rumination, threat monitoring and unhelpful coping) is thought to link stress to anxiety and depression. Metacognitive therapy targets this thinking style, and low-intensity self-help books may make these principles accessible to students.
A total of 165 students at İstanbul Nişantaşı University will be randomly assigned to one of three groups: two groups each receive a different self-help book and read it at their own pace over 8 weeks, and the third group (waitlist) receives the books after the study ends. All participants complete short online questionnaires (DASS-21, CAS-1, MCQ-30) at the start, at week 4 and at week 8, and receive brief telephone calls at weeks 2, 4 and 6 to confirm participation.
Detailed description
Design: Single-site, parallel-group, three-arm randomized controlled trial at İstanbul Nişantaşı University, Istanbul, Türkiye.
Participants: Students aged 18 years or older enrolled in medicine or health-sciences programs (medicine, psychology, nursing and dentistry), recruited through announcements (student WhatsApp groups, e-mail and brief in-class presentations). Participation is voluntary and has no effect on academic standing.
Arms: (1) Bibliotherapy with the self-help book "Zihninde Çok Kuran İnsanlar için Salma Rehberi"; (2) bibliotherapy with the self-help book "Çapa Atmak"; (3) waitlist control, assessment only during the study period, with books provided at the end of the study. Reading is self-paced over 8 weeks without therapist contact.
Randomization: After completion of baseline assessments, participants are allocated 1:1:1 using a computer-generated random sequence (Randomizer.org). Faculty and baseline DASS-21 total score are taken into account to support balance between groups; the DASS-21 score is not used as an inclusion threshold. The allocation list is stored securely by the research team, and allocation is not disclosed until baseline assessments are complete.
Sample size: G*Power 3.1, medium effect size (f = 0.25), three groups, α = 0.05, power 80%: minimum 159 participants. 165 participants (55 per arm) are targeted.
Measures and schedule: Sociodemographic form at baseline. Depression Anxiety Stress Scales-21 (DASS-21), Cognitive Attentional Syndrome Scale-1 (CAS-1) and Metacognitions Questionnaire-30 (MCQ-30) at week 0, week 4 and week 8, collected online through a study website after electronic informed consent. Process measures: a weekly one-item reading log in the two bibliotherapy arms, and a three-item contamination form at week 8.
Telephone contact: All participants, including the waitlist group, receive brief standardized telephone calls at weeks 2, 4 and 6 to confirm participation, reading progress and completion of forms. Calls follow a fixed script, serve reminder and confirmation purposes only, and contain no therapeutic content or guidance about the books, so that contact intensity is equal across arms.
Safety: Participants with current psychiatric treatment, a recent change in psychotropic medication, bipolar disorder, acute psychotic symptoms or suicide risk are not included. If questionnaire responses indicate a high level of distress during the study, the research team contacts the participant and refers them to appropriate mental health services.
Analysis: Repeated-measures ANOVA (or non-parametric alternatives) to examine group × time effects, with baseline scores taken into account; partial eta-squared is reported as the effect size; intention-to-treat principles are applied for missing data. SPSS is used.
Data protection: Participants are identified only by study codes. Telephone numbers are collected with consent for study contact only and stored separately from the dataset. Data are stored under encryption in accordance with Turkish personal data protection law (KVKK), and no personal identifiers appear in reports or publications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three-arm parallel-group randomized controlled trial: two bibliotherapy arms (two different self-help books, read over 8 weeks) and one waitlist control arm; 1:1:1 allocation.
| Arm | Type | Receives |
|---|---|---|
| Bibliotherapy - Group 1 | Experimental | Behavioral: Zihninde Çok Kuran İnsanlar için Salma RehberiParticipants receive the self-help book "Zihninde Çok Kuran İnsanlar için Salma Rehberi" at study start and read it at their own pace over 8 weeks. They complete online questionnaires at weeks 0, 4 and 8, a weekly one-item reading log, and receive brief telephone calls at weeks 2, 4 and 6. |
| Waiting List Control | No intervention | –Participants complete the same online questionnaires at weeks 0, 4 and 8 and receive the same brief telephone calls at weeks 2, 4 and 6. The study books are provided after the 8-week study period. |
| Bibliotherapy - Group 2 | Experimental | Behavioral: Çapa AtmakParticipants receive the self-help book "Çapa Atmak" at study start and read it at their own pace over 8 weeks. They complete online questionnaires at weeks 0, 4 and 8, a weekly one-item reading log, and receive brief telephone calls at weeks 2, 4 and 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or older
- Currently enrolled as a student in a medicine or health-sciences program (medicine, psychology, nursing and dentistry) at İstanbul Nişantaşı University
- Sufficient proficiency in reading and understanding Turkish
- Access to an internet-connected device to complete online forms
- Electronic informed consent
Key exclusion criteria (5 listed)
- Currently receiving active psychiatric treatment (psychotherapy or psychotropic medication)
- Change in psychotropic medication within the last 6 months
- Having previously read either of the study books
- Diagnosis of bipolar disorder
- Acute psychotic symptoms or current suicide risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zihninde Çok Kuran İnsanlar için Salma RehberiStructured self-help book based on metacognitive therapy principles, targeting the Cognitive Attentional Syndrome (worry, rumination, threat monitoring and unhelpful coping strategies). Participants read the book at their own pace over 8 weeks without therapist contact. Reading progress is recorded with a weekly one-item online reading log. | Behavioural | Bibliotherapy - Group 1 |
| Çapa AtmakSelf-help book read under the same conditions as Intervention 1: self-paced reading over 8 weeks without therapist contact, with a weekly one-item online reading log. | Behavioural | Bibliotherapy - Group 2 |
Primary outcome
Change in Depression, Anxiety, and Stress Scales (DASS-21) total score
Time frame: Baseline (week 0) to week 8
DASS-21 (Turkish version), 21 items rated 0-3; total score is the sum of all items (range 0-63). Higher scores indicate greater psychological distress. Change from baseline to week 8 is compared between groups.
3 secondary outcomes
Change in Cognitive Attentional Syndrome Scale-1 (CAS-1) score
Time frame: Baseline (week 0), week 4 and week 8
Change in Metacognitions Questionnaire-30 (MCQ-30) total score
Time frame: Baseline (week 0), week 4 and week 8
Change in DASS-21 Anxiety subscale score
Time frame: Baseline (week 0), week 4 and week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team. This is in line with the ethics committee approval and the informed consent form, which state that data will be used only by the research team for the purposes of this study. Aggregate results will be published in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zihninde Çok Kuran İnsanlar için Salma Rehberi and Çapa Atmak in people with Anxiety and Depression, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alişan Burak Yaşar, MD, Assoc. Prof. (+90 532 424 30 58, alisanburak.yasar@nisantasi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depression, Anxiety, and Stress Scales (DASS-21) total score (time frame: Baseline (week 0) to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.