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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Placebo Group | Placebo Comparator | This arm is the placebo group, which will be undergoing a group-based attentional control intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrolment to follow-up (6 weeks time frame) |
| Change from baseline Anxiety score to the follow-up moment (6 weeks duration |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roxana Cardoș, PhD | Contact | 0040751477323 | roxanaoltean@psychology.ro |
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Will share IPD used in the results of the publication.
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.
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| ID | Term |
|---|---|
| C000719207 | Necrophobia |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Placebo | Other | The placebo condition consists of a group-based attentional control intervention. |
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Anxiety measured with Generalized Anxiety Disorder - 7 (Spitzer, 2006). Scores range from 0 to 27, with higher scores indicating more severe anxiety symptoms. |
| 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. | 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. | 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. | 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:
| From enrolment to follow-up (6 weeks time frame) |