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

NCT06810999 | Not Yet Recruiting

• 1 other identifier: 816/22.01.2025
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Death Anxiety; Depression; Anxiety

Keywords

death anxiety; depression; anxiety; transdiagnostic; indirect intervention; rct

Outcome Measures

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.

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

Secondary Outcomes (6)

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

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

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

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

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

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

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

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

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

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

Other Outcomes (1)

• Satisfaction with the intervention protocol

  One month

Study Arms (2)

Experimental Group

EXPERIMENTAL

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 Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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).

Experimental Group

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Babes-Bolyai University: lead

MeSH Terms

Conditions

Necrophobia; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Roxana Cardoș, PhD

CONTACT

0040751477323; roxanaoltean@psychology.ro

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: June 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD will be shared after publication with no end date. The Study Protocol will be shared in March 2025 with no end date. The Statistical Analysis Plan will be shared in March 2025 with no end date. The Informed Consent Form will be shared in March 2025 with no end date.