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NCT Number: NCT06810999

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

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.

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Key information

Conditions

Death Anxiety Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Necrophobia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

From Fear to Purpose (Acceptance and Commitment Therapy)

Other

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).

Placebo

Other

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

Primary outcomes

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

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

    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.

Secondary outcomes

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

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

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

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

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

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

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

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

    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.

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

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

    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.

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

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

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

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

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

    Valued Living measured with Valuing Questionnare (Smout, 2014).

    The measure has two subscales:

    • Progress, where scores range from 0 to 30, higher scores indicating a closer alignment between one's internal values and one's actions.
    • Obstruction, where scores range from 0 to 30, higher scores indicating more interference with living consistently with one's values.

Other outcomes

  1. Satisfaction with the intervention protocol

    Time frame: One month

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Roxana Cardoș, PhD

CONTACT

[email protected]

0040751477323

Sponsors and collaborators

Lead sponsor

Babes-Bolyai University

Other

Registry information

Official study title

From Fear to Purpose ACT Protocol: Testing Indirect, Transdiagnostic Implications of Death Anxiety Over Depression and Anxiety. A Randomized Placebo Controlled Trial.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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