The Effectiveness of an Online Self-Delivered Death Anxiety Intervention

Not Applicable

• Conditions: Death Anxiety

• Registration Number: NCT06801132
• Lead Sponsor: Peking University

Brief Summary

The goal of this clinical trial is to examine the effectiveness of the online self-delivered death anxiety intervention developed by our team in the general population with a randomized controlled trial. The study will recruit 50 participants, with 25 randomized to the death anxiety intervention group and 25 randomized to the control group (waiting list). The online intervention on death anxiety consists of 4 phases that take about 2 hours in total. The primary outcome DAS (Death Anxiety Scale) and DABBS (Death Anxiety Beliefs and Behaviors Scale) will be administered on baseline, post-treatment, 1-month follow-up, and 3-month follow-up assessments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-30
• Status Verified: 2025-02
• Study Start: 2025-02-14
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18-65 years of age
• Normal literacy skills and ability to use a smartphone proficiently
• Higher death anxiety that is above the cutoff of our measurement
• Voluntarily participate in this intervention and be able to provide informed consent.

Exclusion Criteria

• Severe depressive state or risk of suicidal self-injury, i.e., the total score of Patient Health Questionnaire 9-item ≥19 or the score of 9th item ≥2
• Diagnosed within 6 months with schizophrenia, depression, bipolar disorder, and other psychiatric disorders
• Have received any intervention for death anxiety or CBT intervention on any topic within the past 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Templer Death Anxiety Scale (T-DAS)	baseline, post treatment(1 week), 5 weeks, 13 weeks	The T-DAS consists of 15 items, describing the experiences that individuals feel when facing death. The Chinese version suggests a 5-point scale according to the later extended version of the scale, ranging from 1 "Strongly Agree" to 5 "Strongly Disagree", with higher scores representing more severe death anxiety. The higher the score, the more serious the death anxiety, and a total score greater than 43 according to the rules can be considered to have a high level of death anxiety. The Chinese version of T-DAS has been widely used and has shown good reliability and validity.
Death Anxiety Beliefs and Behaviors Scale (DABBS)	baseline, post treatment(1 week), 5 weeks, 13 weeks	The DABBS consists of 18 entries describing overall feelings about death (4 entries), thoughts and beliefs related to death (7 entries), and avoidance behaviors related to death (7 entries), with the scale being scored on a 5-point scale ranging from 1, "Strongly Disagree/Never Have This Thought/Never Avoid This Behavior" to 5 "Strongly agree/always have this thought/always avoid this behavior," with higher scores representing the severity of the individual's adverse beliefs and behaviors regarding death.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 9-item	baseline, post treatment(1 week), 5 weeks, 13 weeks	Patient Health Questionnaire 9-item (PHQ-9), a self-report measure for depressive symptoms in the past two weeks, comprises 9 items rated from 0 (not at all) to 3 (nearly every day). The PHQ-9 has good psychometric properties in Chinese adolescents.
Generalized Anxiety Disorder 7-item	baseline, post treatment(1 week), 5 weeks, 13 weeks	Generalized Anxiety Disorder 7-item (GAD-7) scale is a 7-item self-report measure to assess anxiety symptoms in the past two weeks. Each item is rated from 0 (not at all) to 3 (nearly every day). The Chinese version GAD-7 score has good psychometric properties among adolescents.
Ryff's Psychological Well-being Scale (PWS)	baseline, post treatment(1 week), 5 weeks, 13 weeks	The short version used in this study contains 18 entries, including six dimensions of positive relations, autonomy, environmental mastery, personal growth, purpose in life, and self-acceptance. The six dimensions of self-acceptance are scored on a 6-point scale ranging from 1 "not at all" to 6 "very much", with higher scores representing higher psychological well-being. The Chinese version of PWS has been translated by Taiwanese scholars and has been proven to have Good reliability and validity.
Insomnia Severity Index (ISI)	baseline, post treatment(1 week), 5 weeks, 13 weeks	The ISI consists of seven items that assess the severity of subjective insomnia in the past two weeks, including, for example, difficulty in falling asleep, sleep satisfaction, impairment of daytime functioning, etc. The total score ranges from 0-28, with higher scores representing more severe insomnia. The Chinese version of ISI has been shown to have good reliability and validity.
4-dimensional anxiety scale	baseline, post treatment(1 week), 5 weeks, 13 weeks	This is a 40-item scale for measuring multi-dimensional anxiety, which includes 4 dimensions (emotional, physiological, cognitive, and behavioral) and 9 subscales (emotional, psychosomatic, autonomic, general cognitive, phobia, over-committed, repetitive, social, and avoidance). The higher the score on this scale, the more severe the anxiety in a certain area.

Trial Locations

Locations (1)

Peking University; 🇨🇳 Peking, Beijing, China