Clinical trial NCT06801132: The Effectiveness of an Online Self-Delivered Death Anxiety Intervention
Official title: The Effectiveness of an Online Self-Delivered Death Anxiety Intervention: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Death Anxiety
Keywords: Death Anxiety
randomized controlled trial
self-delivered
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: 101 Institute, Ministry of Civil Affairs of the People's Republic of China
First posted: 2025-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Templer Death Anxiety Scale (T-DAS)
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: Death Anxiety Beliefs and Behaviors Scale (DABBS)
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
Secondary outcomes:
measure: Patient Health Questionnaire 9-item
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: Generalized Anxiety Disorder 7-item
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: 4-dimensional anxiety scale
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: Ryff's Psychological Well-being Scale (PWS)
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
Other outcomes:
measure: Adverse Childhood Experiences
timeFrame: baseline
measure: Social support
timeFrame: baseline, 5 weeks
measure: Post-traumatic responses scale - Flight subscale
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: Irritability
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: A sense of stability
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: Alexithymia
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
measure: Emotion regulation
timeFrame: baseline, post treatment(1 week), 5 weeks, 13 weeks
Locations:
city: Peking
country: China
facility: Peking University
state: Beijing
Study officials:
References: