- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06876103
Effectiveness of an Online Religiously-integrated Cognitive Behavioral Therapy-based Intervention on Death Anxiety (RCBT-DA)
Investigating the Effectiveness of an Online Religiously-integrated Cognitive Behavioral Therapy-based Intervention on Death Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Büşra Kavla, PhD Student
- Phone Number: 00905435978136
- Email: busra.kavla@stu.ihu.edu.tr
Study Contact Backup
- Name: Burcu Uysal, Associate Professor
- Phone Number: 00905365150970
- Email: burcu.uysal@ihu.edu.tr
Study Locations
-
-
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İstanbul, Turkey, 34480
- Ibn Haldun University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18-65
- A score of > 26 on the Turkish Death Anxiety Scale
- Diagnosed with one of the anxiety disorders
- Believing in life after death
Exclusion Criteria:
- Diagnosed with schizophrenia, schizophreniform disorder, schizoaffective disorder, and delusional disorder
- Being in an active manic episode
- Possessing a mental disorder that interferes with completing measures or understanding the exercises conducted during sessions
- Extreme symptoms of depression (score of > 20 on the Patient Health Questionnaire (PHQ-9), and >1 on the item assessing suicidality)
- Currently receiving therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Religiously Integrated CBT Group
Participants will receive a novel online RCBT-based intervention consisting of 7 weekly 90-minute sessions in a group format.
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This study aims to assess the efficacy and feasibility of a newly developed online intervention for death anxiety based on Religiously Integrated Cognitive Behavioral Therapy (RCBT). Building upon the framework of Furer and Walker's 2008 intervention protocol, this adaptation incorporates beliefs in an afterlife, aligning with Turkish society's cultural and religious values. The RCBT intervention consists of seven structured group therapy sessions, each lasting 90 minutes. The program is designed to help participants identify and challenge unhelpful thoughts related to death anxiety while integrating religious resources to promote cognitive restructuring. Key components of the intervention include psychoeducation, cognitive restructuring, exposure exercises, the concept of repentance in the context of trust and belief in the afterlife, gratitude, and value-oriented behaviors. |
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Active Comparator: Classical CBT Group
Participants will receive an online CBT intervention based on Furer and Walker's (2008) protocol, consisting of 7 weekly 90-minute sessions in a group format.
|
The standard CBT intervention follows the structured protocol developed by Furer and Walker (2008), which targets cognitive distortions, avoidance behaviors, and excessive safety-seeking behaviors contributing to death anxiety. The researcher has adapted the session content to fit the protocol's core components while maintaining fidelity to the original intervention model. Sessions last 90 minutes and are conducted in an online group format. Session Structure: Session 1: Treatment Rationale, Session 2: Reducing Excessive Checking, Reassurance Seeking, and Safety Behaviors, Session 3: Exposure, Session 4: Cognitive Reappraisal, Session 5: Enhancing Enjoyment of Life, Session 6: Healthy Lifestyle, and Session 7: Relapse Prevention. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turkish Death Anxiety Scale (TDAS)
Time Frame: Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
The Turkish Death Anxiety Scale consists of 20 items that are divided into three subscales: (a) ambiguity of death, (b) exposure to death, and (c) agony of death.
These subscales exhibit strong internal consistency, with Cronbach's alpha values of .91,
.94,
.76
respectively, adding up to a total of .95).
It consists of a five-point Likert (0 = Never to 4 = Always).
Subscale scores are determined by summing the individual item scores, and the total scale score is determined by summing the subscale scores.
Total scale scores can be between 0 and 80, and the higher the score, the greater the level of DA.
A score range of 0-7 indicates very low-level DA, 8-25 indicates low-level DA, 26-44 indicates medium-level DA, 45-63 indicates high-level DA, and 64-80 indicates very high-level DA.
|
Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
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Abdel-Khalek's Death Anxiety Scale (ASDA)
Time Frame: Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
Abdel-Khalek's Death Anxiety Scale is a 20-item questionnaire that measures DA.
The scale is one-dimensional.
Higher scores indicate a greater degree of DA.
It consists of a five-point Likert (1 = No to 5 = Very much).
The Turkish reliability and validity of the scale were conducted by Sarıçiçek-Aydoğan et al. in 2015 (Cronbach's alpha = .86).
|
Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
Generalized Anxiety Disorder-7 consists of a four-point Likert (0 = never to3 = almost every day) and 7 items that assess anxiety symptoms.
The highest score that can be attained ranges up to 21.
A score range of 0-4 indicates mild anxiety, 5-9 indicates moderate anxiety, 10-14 indicates high anxiety, and 15-21 indicates severe anxiety.
A cut-off point of 10 points was determined for the total score.
The Turkish reliability and validity of the scale were conducted by Konkan et al. in 2013 (Cronbach's alpha = .85).
|
Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
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Patient Health Questionnaire (PHQ-9)
Time Frame: Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
Patient Health Questionnaire consists of a four-point Likert and nine items that screen depressive symptoms.
Each of these items is rated on a scale of 0 (never) to 3 (almost every day).
The highest score that can be attained ranges up to 27.
A score range of 1-4 indicates low depressive symptoms, 5-9 indicates mild depressive symptoms, 10-14 indicates moderate depressive symptoms, 15-19 indicates partially severe depressive symptoms, and 20-27 indicates severe depressive symptoms.
The Turkish reliability and validity of the scale were conducted by Sarı et al. (2016) (Cronbach's alpha = .84).
|
Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Belief in a Day of Judgment Scale
Time Frame: Baseline (pretest), Week 7 (posttest), 3-month follow-up
|
The Belief in a Day of Judgment Scale comprises 20 items with two subscales: (1) belief in a day of judgment, and (2) bad behavior/actions toward others.
It consists of a five-point Likert (1 = Strongly disagree to 5 = Strongly agree).
Examples of the items include, "God is the savior and judge of mankind.", and "If I am pure of heart and hands, I shall live in the fear of a just God".
A high score on the Belief in a Day of Judgment subscale indicates a strong belief in a Day of Judgment, the conviction that God will judge the living and the dead, and the belief in life after death.
A high score on the Bad Behavior/Actions Toward Others subscale reflects the belief that human relationships and actions towards others will be scrutinized on the Day of Judgment.
The Turkish reliability and validity of the scale were conducted by Turan et al. in 2020 (Cronbach's alpha = .92).
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Baseline (pretest), Week 7 (posttest), 3-month follow-up
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Muslim Practice and Belief Scale
Time Frame: Baseline (pretest), Week 7 (posttest), 3-month follow-up
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The Muslim Practice and Belief Scale- Short Form comprises nine items with two subscales: (1) social beliefs and prayers, and (2) individual beliefs and prayers subscale (PF).
It consists of a five-point Likert (1 = Strongly Disagree to 5 = Strongly Agree).
The Turkish reliability and validity of the scale were conducted by Akın and Yalnız in 2015 (Cronbach's alpha = .90).
The subscales demonstrate good internal consistency, with Cronbach's alphas of.
86 and .91 respectively.
Higher scores indicate a greater level of Muslim practice and belief.
|
Baseline (pretest), Week 7 (posttest), 3-month follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Büşra Kavla, PhD Student, Ibn Haldun University
- Study Chair: Burcu Uysal, Associate Professor, Ibn Haldun University
Publications and helpful links
General Publications
- Aydoğan, A. S., Gülseren, Ş., Sarıkaya, Ö. Ö., & Özen, Ç. (2015). Abdel-Khalek ölüm anksiyetesi ölçeği Türkçe formunun üniversite öğrencilerinde geçerlilik ve güvenilirliği. Nöropsikiyatri Arşivi, 52, 371-375.
- Abdel-Khalek AM. A general factor of death distress in seven clinical and non-clinical groups. Death Stud. 2004 Nov;28(9):889-98. doi: 10.1080/07481180490491040.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024/04-14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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