Earthquake VictimNCT06174350
Evaluation of the Effect of Cognitive Behavioral Therapy in Individuals Exposed to Earthquakes
A study testing Cognitive behavioral therapy in people with Earthquake Victim, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
This mixed-methods randomized controlled trial evaluated the effect of individual cognitive behavioral therapy (CBT) on ruminative thoughts and cognitive distortions in adults exposed to the 6 February 2023 earthquake in Türkiye and living in a temporary accommodation center (container city) in Osmaniye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Earthquake Victim
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2023to 22 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Aged 18 years or older
- Exposed to the 6 February 2023 earthquake and living in the temporary accommodation center (container city)
- No language or communication barrier
- Not actively receiving psychological support during the intervention period
Who cannot join
- Having a diagnosed psychiatric disorder
- Having previously received a similar education/therapy approach
- Missing more than 10% of the intervention
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaçay Temporary Accommodation Center
Osmaniye, Osmaniye
About this study
Official title: Evaluation of the Effect of Cognitive Behavioral Therapy on Ruminative Thoughts and Cognitive Distortions in Individuals Exposed to Earthquakes
This mixed-methods randomized controlled trial evaluated the effect of individual cognitive behavioral therapy (CBT) on ruminative thoughts and cognitive distortions in adults exposed to the 6 February 2023 earthquake in Türkiye and living in a temporary accommodation center (container city) in Osmaniye. Participants were randomly allocated to a CBT group or a no-intervention control group. Ruminative thoughts and cognitive distortions were assessed at baseline, after the 8-week intervention, and at 3-month follow-up, and the experiences of participants in the CBT group were explored through semi-structured interviews.
Read the detailed description
Earthquakes affect the lives of many people, and evaluating and supporting the psychological state of survivors is important. No study was identified that evaluated the effect of cognitive behavioral therapy (CBT) on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes. This doctoral thesis study was therefore conducted to evaluate this effect.
Design: Randomized controlled, embedded mixed-methods study. The quantitative component is a two-arm, parallel-group randomized controlled trial with pretest, posttest and 3-month follow-up; the qualitative component consists of semi-structured interviews with participants in the intervention group.
Setting and population: Adults aged 18 years and older living in the Karaçay Temporary Accommodation Center (container city), Osmaniye, Türkiye.
Sample size: Calculated with G*Power 3.1.9.2 (alpha = 0.01, power = 0.99, effect size = 1.52), giving a minimum of 23 participants per group (46 in total). To allow for attrition, 30 individuals were allocated to each group.
Randomization: Individuals were selected from the center's resident list and allocated to the groups using computer-generated random numbers (random.org) by a biostatistician who was not involved in recruitment, data collection or delivery of the intervention.
Intervention: The intervention group received individual CBT in 8 weekly sessions, each lasting 45-60 minutes. The control group received no intervention.
Data collection: Pretest 26-27 October 2023; posttest 21-22 December 2023; 3-month follow-up 21-22 March 2024. Instruments: Sociodemographic Data Form, Ruminative Thought Style Questionnaire, Cognitive Distortions Scale, and a semi-structured interview form.
Data analysis: Quantitative data were analyzed with SPSS 26.0 and qualitative data with MAXQDA 2020.
Written and verbal informed consent was obtained from all participants.
- Conditions
- Earthquake Victim
- Being tested
- Cognitive behavioral therapy
- Keywords
- Cognitive Distortions, Mixed Methods, Cognitive Behavioral Therapy, Earthquake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Individual CBT delivered by a psychiatric nurse with certified CBT training in 8 weekly sessions of 45-60 minutes. Session 1: rapport building, explanation of the process, informed consent, pretest and introduction of the CBT/ABC model. Sessions 2-7: mood check, agenda setting, assessment of ruminative thoughts and cognitive distortions related to the earthquake and daily life, homework review, breathing and relaxation exercises, journaling, Socratic questioning, problem-solving techniques, and work on cognitive distortions (sessions 3-5) and ruminative thoughts (sessions 6-7). Session 8: evaluation of therapy, semi-structured questions and posttest.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive behavioral therapy group | Experimental | Participants received individual cognitive behavioral therapy in 8 weekly sessions, each lasting 45-60 minutes. Receives: Behavioral: Cognitive behavioral therapy |
| Control group | No intervention | No intervention was provided to the control group. Participants completed the same assessments at the same time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ruminative Thought Style Questionnaire (RTSQ) total score
20-item self-report scale rated on a 7-point Likert scale (Brinker \& Dozois, 2009; Turkish adaptation by Karatepe, 2010). Total score ranges from 20 to 140; higher scores indicate more ruminative thinking.
Measured: Baseline, post-intervention (week 8) and 3-month follow-up
Secondary outcomes (1)
Cognitive Distortions Scale (CDS) total score
Scenario-based self-report scale assessing 10 types of cognitive distortions in interpersonal and achievement situations, rated on a 7-point scale (Covin et al., 2011; Turkish adaptation by Ardanıç, 2017). Total score ranges from 20 to 140; higher scores indicate more frequent cognitive distortions.
Measured: Baseline, post-intervention (week 8) and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start26 Oct 2023
- Primary completion22 Dec 2023
- Study completion22 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Earthquake VictimStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled trial with 1:1 allocation: individual CBT group and no-intervention control group.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adile Bozkurt Tonguc, Osmaniye Korkut Ata University
- Investigators
- Adile Bozkurt Tonguç, Principal investigator, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174350
- Sponsor's protocol ID
- OsmaniyeKAU-SBF-ABT-01
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (questionnaire scores and sociodemographic variables) underlying the results reported in the publication will be shared with researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cognitive Behavioral Therapy on Ruminative Thoughts and Cognitive Distortions in Individuals Exposed to Earthquakes
- ClinicalTrials.gov ID
- NCT06174350
- Acronym / sponsor ID
- OsmaniyeKAU-SBF-ABT-01
- Conditions
- Earthquake Victim
- Keywords
- Cognitive Distortions, Mixed Methods, Cognitive Behavioral Therapy, Earthquake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Mar 2024 (actual)
- First posted
- 18 Dec 2023 (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 mixed-methods randomized controlled trial evaluated the effect of individual cognitive behavioral therapy (CBT) on ruminative thoughts and cognitive distortions in adults exposed to the 6 February 2023 earthquake in Türkiye and living in a temporary accommodation center (container city) in Osmaniye. Participants were randomly allocated to a CBT group or a no-intervention control group. Ruminative thoughts and cognitive distortions were assessed at baseline, after the 8-week intervention, and at 3-month follow-up, and the experiences of participants in the CBT group were explored through semi-structured interviews.
Detailed description
Earthquakes affect the lives of many people, and evaluating and supporting the psychological state of survivors is important. No study was identified that evaluated the effect of cognitive behavioral therapy (CBT) on ruminative thoughts and cognitive distortions in individuals exposed to earthquakes. This doctoral thesis study was therefore conducted to evaluate this effect.
Design: Randomized controlled, embedded mixed-methods study. The quantitative component is a two-arm, parallel-group randomized controlled trial with pretest, posttest and 3-month follow-up; the qualitative component consists of semi-structured interviews with participants in the intervention group.
Setting and population: Adults aged 18 years and older living in the Karaçay Temporary Accommodation Center (container city), Osmaniye, Türkiye.
Sample size: Calculated with G*Power 3.1.9.2 (alpha = 0.01, power = 0.99, effect size = 1.52), giving a minimum of 23 participants per group (46 in total). To allow for attrition, 30 individuals were allocated to each group.
Randomization: Individuals were selected from the center's resident list and allocated to the groups using computer-generated random numbers (random.org) by a biostatistician who was not involved in recruitment, data collection or delivery of the intervention.
Intervention: The intervention group received individual CBT in 8 weekly sessions, each lasting 45-60 minutes. The control group received no intervention.
Data collection: Pretest 26-27 October 2023; posttest 21-22 December 2023; 3-month follow-up 21-22 March 2024. Instruments: Sociodemographic Data Form, Ruminative Thought Style Questionnaire, Cognitive Distortions Scale, and a semi-structured interview form.
Data analysis: Quantitative data were analyzed with SPSS 26.0 and qualitative data with MAXQDA 2020.
Written and verbal informed consent was obtained from all participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial with 1:1 allocation: individual CBT group and no-intervention control group.
| Arm | Type | Receives |
|---|---|---|
| Cognitive behavioral therapy group | Experimental | Behavioral: Cognitive behavioral therapyParticipants received individual cognitive behavioral therapy in 8 weekly sessions, each lasting 45-60 minutes. |
| Control group | No intervention | –No intervention was provided to the control group. Participants completed the same assessments at the same time points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older
- Exposed to the 6 February 2023 earthquake and living in the temporary accommodation center (container city)
- No language or communication barrier
- Not actively receiving psychological support during the intervention period
Key exclusion criteria (3 listed)
- Having a diagnosed psychiatric disorder
- Having previously received a similar education/therapy approach
- Missing more than 10% of the intervention
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 |
|---|---|---|
| Cognitive behavioral therapyIndividual CBT delivered by a psychiatric nurse with certified CBT training in 8 weekly sessions of 45-60 minutes. Session 1: rapport building, explanation of the process, informed consent, pretest and introduction of the CBT/ABC model. Sessions 2-7: mood check, agenda setting, assessment of ruminative thoughts and cognitive distortions related to the earthquake and daily life, homework review, breathing and relaxation exercises, journaling, Socratic questioning, problem-solving techniques, and work on cognitive distortions (sessions 3-5) and ruminative thoughts (sessions 6-7). Session 8: evaluation of therapy, semi-structured questions and posttest. | Behavioural | Cognitive behavioral therapy group |
Primary outcome
Ruminative Thought Style Questionnaire (RTSQ) total score
Time frame: Baseline, post-intervention (week 8) and 3-month follow-up
20-item self-report scale rated on a 7-point Likert scale (Brinker \& Dozois, 2009; Turkish adaptation by Karatepe, 2010). Total score ranges from 20 to 140; higher scores indicate more ruminative thinking.
1 secondary outcome
Cognitive Distortions Scale (CDS) total score
Time frame: Baseline, post-intervention (week 8) and 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (questionnaire scores and sociodemographic variables) underlying the results reported in the publication will be shared with researchers who provide a methodologically sound proposal.
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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. This study is not recruiting at the moment.
Adile Bozkurt Tonguç principal investigator
Osmaniye Korkut Ata University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Earthquake Victim, run by Osmaniye Korkut Ata 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 26 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ruminative Thought Style Questionnaire (RTSQ) total score (time frame: Baseline, post-intervention (week 8) and 3-month follow-up). 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 26 Oct 2026.