Clinical trial NCT06810999: From Fear to Purpose ACT Protocol. Implications of Death Anxiety in Depression and Anxiety Symptoms.
Official title: From Fear to Purpose ACT Protocol: Testing Indirect, Transdiagnostic Implications of Death Anxiety Over Depression and Anxiety. A Randomized Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Death Anxiety
Depression
Anxiety
Keywords: death anxiety
depression
anxiety
transdiagnostic
indirect intervention
rct
Lead sponsor: Babes-Bolyai University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 175
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 main purpose of this placebo controlled trial is to test the efficacy of a one-session From Fear to Purpose ACT intervention in reducing self-reported death anxiety levels. Another objective of this study is to investigate whether reductions in death anxiety levels are associated with reductions in depression and anxiety levels, thus testing if death anxiety is a transdiagnostic factor involved in psychopathology.

Detailed description: This is a placebo controlled trial where the main objective is to test if the one-session From Fear to Purpose ACT intervention is effective in reducing self-reported death anxiety levels. A secondary objective is to investigate whether reductions in death anxiety levels are associated with reductions in depression and anxiety levels, thus testing if death anxiety is a transdiagnostic factor involved in psychopathology.

Participants will be selected based on death anxiety levels (moderate-high scores) and depression and anxiety symptoms (subclinical levels). Minors, people with suicidal ideation, people with current psychological/psychiatric diagnosis (excepting depression or anxiety diagnosis), people in active psychological/psychiatric treatment will be excluded. Recruited participants will be randomized into two groups: the experimental group (will receive the From Fear to Purpose ACT intervention) and the placebo group. The placebo condition will be undergoing a group-based attentional control activity. Participants will be blinded to the study condition.

The From Fear to Purpose intervention protocol is based on Acceptance and Commitment Therapy (ACT) strategies, build around identifying and committing to personal values. The intervention will be group-based (90 minutes session). The intervention will be administered by experienced psychotherapists.

The primary outcome is death anxiety, while secondary outcomes are depression and anxiety symptoms, well-being, psychological flexibility, experiential avoidance and valued living.

Eligibility criteria: Inclusion Criteria:

* Moderate-high levels of death anxiety (score \> or = 55) AND
* Subclinical levels of depression (score \> or = 9) AND/OR
* Subclinical levels of anxiety (score \> or = 9)

Exclusion Criteria:

* Minors
* Suicidal ideation
* Current psychological/psychiatric diagnosis (except depression or anxiety diagnosis)
* Active psychological/psychiatric treatment

Primary outcomes:
measure: Change from baseline Death Anxiety score to the follow-up moment (6 weeks duration)
timeFrame: From enrolment to follow-up (6 weeks time frame)
Secondary outcomes:
measure: Change from baseline Depression score to the follow-up moment (6 weeks duration)
timeFrame: From enrolment to follow-up (6 weeks time frame)
measure: Change from baseline Anxiety score to the follow-up moment (6 weeks duration
timeFrame: From enrolment to follow-up (6 weeks time frame)
measure: Change from baseline Well-being score to the follow-up moment (6 weeks duration)
timeFrame: From enrolment to follow-up (6 weeks time frame)
measure: Change from baseline Psychological Flexibility to the follow-up moment (6 weeks duration)
timeFrame: From enrolment to follow-up (6 weeks time frame)
measure: Change from baseline Experiential Avoidance score to the follow-up moment (6 weeks duration
timeFrame: From enrolment to follow-up (6 weeks time frame)
measure: Change from baseline Valued Living score to the follow-up moment (6 weeks duration
timeFrame: From enrolment to follow-up (6 weeks time frame)
Other outcomes:
measure: Satisfaction with the intervention protocol
timeFrame: One month
Locations:
Study officials:
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