The Effectiveness of an Online Self-Delivered Death Anxiety Intervention
The Effectiveness of an Online Self-Delivered Death Anxiety Intervention: A Pilot Randomized Controlled Trial
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100871
- Peking University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Death anxiety
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The online self-guided death anxiety intervention developed in this study is based on the Death Education and CBT framework. It took approximately two hours to complete the full intervention. The main content includes:
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Other: Waiting-List (WL) condition
Participants assigned to WL will be asked not to use our death anxiety intervention or seek additional help related to death anxiety during the 1-week intervention period.
After the one-month follow-up of the experimental group, the WL group will receive the same intervention for death anxiety.
WL participants will also be given contact information to use in case of increasing distress.
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Participants assigned to WL will be asked not to use our death anxiety intervention or seek additional help related to death anxiety during the 1-week intervention period.
After the one-month follow-up of the experimental group, the WL group will receive the same intervention for death anxiety.
WL participants will also be given contact information to use in case of increasing distress.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Templer Death Anxiety Scale (T-DAS)
Time Frame: baseline, post treatment (only for intervention group), 1 week, 2 weeks
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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.
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baseline, post treatment (only for intervention group), 1 week, 2 weeks
|
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Death Anxiety Beliefs and Behaviors Scale (DABBS)
Time Frame: baseline, post treatment (only for intervention group), 1 week, 2 weeks
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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.
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baseline, post treatment (only for intervention group), 1 week, 2 weeks
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire 9-item
Time Frame: baseline, 1 week, 2 weeks
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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.
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baseline, 1 week, 2 weeks
|
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Generalized Anxiety Disorder 7-item
Time Frame: baseline, 1 week, 2 weeks
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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.
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baseline, 1 week, 2 weeks
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Insomnia Severity Index (ISI)
Time Frame: baseline, 1 week, 2 weeks
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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.
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baseline, 1 week, 2 weeks
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4-dimensional anxiety scale
Time Frame: baseline, 1 week, 2 weeks
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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.
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baseline, 1 week, 2 weeks
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Ryff's Psychological Well-being Scale (PWS)
Time Frame: baseline, post treatment (only for intervention group), 1 week, 2 weeks
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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.
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baseline, post treatment (only for intervention group), 1 week, 2 weeks
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Other Outcome Measures
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Childhood Experiences
Time Frame: baseline
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An adverse childhood experiences questionnaire measuring the adverse childhood experiences with 13 items.
A higher number of adverse childhood experiences represents worse childhood experiences.
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baseline
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Social support
Time Frame: baseline, 1 week, 2 weeks
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The 12-item Multidimensional Scale of Perceived Social Support (score from 1 to 7, and total score varies from 12 to 84).
A higher score represents better social support.
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baseline, 1 week, 2 weeks
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Post-traumatic responses scale - Flight subscale
Time Frame: baseline, 1 week, 2 weeks
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This is a 9-item subscale measuring flight responses of the Post-traumatic responses scale, which is a 5-point Likert scale (score from 0 to 4, and total score varies from 0 to 36).
A higher score represents a higher post-traumatic avoidance tendency.
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baseline, 1 week, 2 weeks
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Irritability
Time Frame: baseline, 1 week, 2 weeks
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A 17-item irritability measurement scale, the Peking irritability scale, measures impulsive emotions, thoughts, and behaviors on a 5-point Likert scale (score from 1 to 5, and total score varies from 17 to 85).
A higher score represents higher irritability.
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baseline, 1 week, 2 weeks
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A sense of stability
Time Frame: baseline, 1 week, 2 weeks
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A 7-item 6-point Likert scale that measures the subjective feeling of being settled and fulfilled in one's current life.
The higher the score on the scale, the stronger the sense of stability.
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baseline, 1 week, 2 weeks
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Alexithymia
Time Frame: baseline, 1 week, 2 weeks
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A 23-item Peking alexithymia scale measures thoughts and behaviors that prevent people from feeling or recognizing negative emotions on a 5-point Likert scale (1 to 5, and total scores vary from 23 to 115).
A higher score represents more severe alexithymia.
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baseline, 1 week, 2 weeks
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Emotion regulation
Time Frame: baseline, 1 week, 2 weeks
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An 18-item cognitive emotion regulation questionnaire measures the ability of emotion regulation on a 5-point Likert scale (1 to 5, and total scores vary from 18 to 90).
A higher score represents better emotion regulation.
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baseline, 1 week, 2 weeks
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- Facing death anxiety pilot
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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