From Fear to Purpose ACT Protocol. Implications of Death Anxiety in Depression and Anxiety Symptoms.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBabes-Bolyai University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Minors
Suicidal ideation
Current psychological/psychiatric diagnosis (except depression or anxiety diagnosis)
Active psychological/psychiatric treatment
Trial design
Design model
Parallel
Treatments tested in this trial
From Fear to Purpose (Acceptance and Commitment Therapy)
Other interventionThe 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 interventionThe placebo condition consists of a group-based attentional control intervention.
Treatment groups
175 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
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)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 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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