Death AnxietyNCT06810999
From Fear to Purpose ACT Protocol. Implications of Death Anxiety in Depression and Anxiety Symptoms.
A study testing From Fear to Purpose (Acceptance and Commitment Therapy) in people with Death Anxiety and Depression, run by Babes-Bolyai University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Death Anxiety, Depression, Anxiety
- What is being tested?
- From Fear to Purpose (Acceptance and Commitment Therapy)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Minors
- Suicidal ideation
- Current psychological/psychiatric diagnosis (except depression or anxiety diagnosis)
- Active psychological/psychiatric treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: From Fear to Purpose ACT Protocol: Testing Indirect, Transdiagnostic Implications of Death Anxiety Over Depression and Anxiety. A Randomized Placebo Controlled Trial.
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.
- Conditions
- Death Anxiety, Depression, Anxiety
- Being tested
- From Fear to Purpose (Acceptance and Commitment Therapy), Placebo
- Keywords
- death anxiety, depression, anxiety, transdiagnostic, indirect intervention, rct
- Medical subject headings
- Necrophobia, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
PlaceboOther
The placebo condition consists of a group-based attentional control intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Depression measured with Patient Health Questionnaire - 9 (Kroenke, 1999). Scores range from 0 to 27 with higher scores indicating more severe depression symptoms.
Measured: From enrolment to follow-up (6 weeks time frame)
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.
Measured: From enrolment to follow-up (6 weeks time frame)
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.
Measured: From enrolment to follow-up (6 weeks time frame)
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.
Measured: From enrolment to follow-up (6 weeks time frame)
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.
Measured: From enrolment to follow-up (6 weeks time frame)
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:
- 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.
Measured: From enrolment to follow-up (6 weeks time frame)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Death AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roxana Cardos, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810999
- Sponsor's protocol ID
- 816/22.01.2025
- Status last verified
- Apr 2025
- First submitted
- 31 Jan 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share IPD used in the results of the publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Fear to Purpose ACT Protocol: Testing Indirect, Transdiagnostic Implications of Death Anxiety Over Depression and Anxiety. A Randomized Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT06810999
- Acronym / sponsor ID
- 816/22.01.2025
- Conditions
- Death Anxiety, Depression, Anxiety
- Keywords
- death anxiety, depression, anxiety, transdiagnostic, indirect intervention, rct
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: From Fear to Purpose (Acceptance and Commitment Therapy)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. |
| Placebo Group | Placebo comparator | Other: PlaceboThis arm is the placebo group, which will be undergoing a group-based attentional control intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- Minors
- Suicidal ideation
- Current psychological/psychiatric diagnosis (except depression or anxiety diagnosis)
- Active psychological/psychiatric treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| From 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). | Other | Experimental Group |
| PlaceboThe placebo condition consists of a group-based attentional control intervention. | Other | Placebo Group |
Primary outcome
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.
6 secondary outcomes
Change from baseline Depression score to the follow-up moment (6 weeks duration)
Time frame: From enrolment to follow-up (6 weeks time frame)
Change from baseline Anxiety score to the follow-up moment (6 weeks duration
Time frame: From enrolment to follow-up (6 weeks time frame)
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)
Change from baseline Psychological Flexibility to the follow-up moment (6 weeks duration)
Time frame: From enrolment to follow-up (6 weeks time frame)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: Yes. Will share IPD used in the results of the publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing From Fear to Purpose (Acceptance and Commitment Therapy) in people with Death Anxiety and Depression, run by Babes-Bolyai University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roxana Cardoș, PhD (0040751477323, roxanaoltean@psychology.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.