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Not yet recruitingNCT06810999Updated Apr 18, 2025

From Fear to Purpose ACT Protocol. Implications of Death Anxiety in Depression and Anxiety Symptoms.

An interventional study of From Fear to Purpose (Acceptance and Commitment Therapy) and Placebo in Death Anxiety, Depression and Anxiety, sponsored by Babes-Bolyai University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-18.

Sponsored by Babes-Bolyai University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
175
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Death Anxiety
  • Depression
  • Anxiety

Keywords

  • death anxiety
  • depression
  • anxiety
  • transdiagnostic
  • indirect intervention
  • rct
03

In context

Death

572 studies on the registry are indexed under Death; 111 are open to participants now.

This study's planned enrollment of 175 is above the median of 133 across 260 interventional studies indexed under Death.

Browse Death studies →

Lead sponsor

Babes-Bolyai University is the lead sponsor of 48 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Minors
  • Suicidal ideation
  • Current psychological/psychiatric diagnosis (except depression or anxiety diagnosis)
  • Active psychological/psychiatric treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
175 participants (estimated)

Study arms

  • Experimental
    Experimental Group

    This arm is the experimental group which will receive the intervention. The intervention is a one session From Fear to Purpose ACT Protocol, which is built on Acceptance and Commitment Therapy (ACT) strategies, focused on identifying and committing to personal values.

    Other: From Fear to Purpose (Acceptance and Commitment Therapy)

  • Placebo comparator
    Placebo Group

    This arm is the placebo group, which will be undergoing a group-based attentional control intervention.

    Other: Placebo

Interventions

  • OtherFrom Fear to Purpose (Acceptance and Commitment Therapy)

    The From Fear to Purpose ACT 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).

  • OtherPlacebo

    The placebo condition consists of a group-based attentional control intervention.

06

What researchers measure

Primary outcomes

  1. Change from baseline Death Anxiety score to the follow-up moment (6 weeks duration)

    Death anxiety measured with Death Anxiety Beliefs and Behaviours Scale (Menzies, Sharpe, Dar-Nimrod, 2022). Scores range from 18 to 90, with higher scores indicating higher death anxiety levels.

    Time frame: From enrolment to follow-up (6 weeks time frame)

Secondary outcomes

  1. Change from baseline Depression score to the follow-up moment (6 weeks duration)

    Depression measured with Patient Health Questionnaire - 9 (Kroenke, 1999). Scores range from 0 to 27 with higher scores indicating more severe depression symptoms.

    Time frame: From enrolment to follow-up (6 weeks time frame)

  2. Change from baseline Anxiety score to the follow-up moment (6 weeks duration

    Anxiety measured with Generalized Anxiety Disorder - 7 (Spitzer, 2006). Scores range from 0 to 27, with higher scores indicating more severe anxiety symptoms.

    Time frame: From enrolment to follow-up (6 weeks time frame)

  3. Change from baseline Well-being score to the follow-up moment (6 weeks duration)

    Distress measured with The World Health Organization-Five Well-Being Index (WHO-5; WHO, 2024). Scores range from 0 to 25 with higher scores indicating better well-being.

    Time frame: From enrolment to follow-up (6 weeks time frame)

  4. Change from baseline Psychological Flexibility to the follow-up moment (6 weeks duration)

    Psychological Flexibility measured with Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT) (Francis, 2016). Scores range from 0 to 138 with higher scores indicating better psychological flexibility.

    Time frame: From enrolment to follow-up (6 weeks time frame)

  5. Change from baseline Experiential Avoidance score to the follow-up moment (6 weeks duration

    Experiential Avoidance measured with Brief Experiential Avoidance Questionnare (Gamez, 2011). Scores range from 15 to 90 with higher scores indicating higher experiential avoidance.

    Time frame: From enrolment to follow-up (6 weeks time frame)

  6. Change from baseline Valued Living score to the follow-up moment (6 weeks duration

    Valued Living measured with Valuing Questionnare (Smout, 2014). The measure has two subscales: 1. Progress, where scores range from 0 to 30, higher scores indicating a closer alignment between one's internal values and one's actions. 2. Obstruction, where scores range from 0 to 30, higher scores indicating more interference with living consistently with one's values.

    Time frame: From enrolment to follow-up (6 weeks time frame)

Other outcomes

  1. Satisfaction with the intervention protocol

    Satisfaction with the intervention protocol measured with Client Satisfaction Questionnaire - 8 (Attkisson, 1982). Measured post intervention and at follow-up for the experimental group. Scores range from 8 to 32, higher scores indicating greater satisfaction with the intervention.

    Time frame: One month

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Will share IPD used in the results of the publication.

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06810999
Lead sponsor
Babes-Bolyai University
Responsible party
Roxana Cardos (PhD, Babes-Bolyai University) — Principal investigator
First posted
Feb 6, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Dec 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Apr 18, 2025

Study contacts

Roxana Cardoș, PhD
Contact
roxanaoltean@psychology.ro
0040751477323

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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