N/A N=606 Randomized Double-blind Basic Science

Stress, Sex, and the Generalization of Fear

Psychological Stress

Bottom Line

View on ClinicalTrials.gov: NCT03786952 ↗

Enrolled (actual)

606

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: Fear-potentiated Startle Responses to the CS+ and CS- During Acquisition — 52.059; 19.162; 44.388; 9.732 Fear-potentiated startle (microvolts) — p=0.453

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Stress immediately before learning in males (Behavioral); Sham control immediately before learning in males (Behavioral); Stress 30 minutes before learning in males (Behavioral); Sham control 30 minutes before learning in males (Behavioral); Stress immediately before learning in females (Behavioral); Sham control immediately before learning in females (Behavioral); Stress 30 minutes before learning in females (Behavioral); Sham control 30 minutes before learning in females (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ohio Northern University
Primary completion: Jun 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Fear-potentiated Startle Responses to the CS+ and CS- During Acquisition	52.059; 19.162; 44.388; 9.732; 42.123; 20.215	0.453
PRIMARY EMG Responses to CS+, CS-, and Generalization Stimuli During Generalization Testing	52.059; 42.389; 24.461; 36.099; 25.637; 13.225	0.931
PRIMARY Skin Conductance Responses to CS+ and CS- During Acquisition	.107; .070; .138; .090; .112; .102	0.923
PRIMARY Skin Conductance Responses to CS+, Generalization Stimuli, and CS- During Generalization Testing	.193; .156; .103; .114; .072; .046	0.399
PRIMARY US Expectancy Ratings to CS+ and CS- During Acquisition	.737; -.865; .964; -.954; .797; -.775	0.872
PRIMARY US Expectancy Ratings to CS+, CS-, and Generalization Stimuli During Generalization Testing	.217; .140; -.357; -.527; -.822; -.810	0.998
SECONDARY Change in Baseline Salivary Cortisol (Nmol/l)	1.413; 1.014; -.039; .236; .728; .710	0.10
SECONDARY Change in Baseline Salivary Alpha-amylase (U/ml)	4.210; -12.943; 7.656; -3.411; 17.561; 2.608	0.992
SECONDARY Average Subjective Pain, as Assessed by Verbal Self Report	6.089; 6.415; .123; .159; 6.806; 6.765	0.519
SECONDARY Average Subjective Stress, as Assessed by Verbal Self Report	4.457; 5.778; .675; .318; 5.910; 5.843	0.007 sig
SECONDARY Change in Heart Rate (Bpm)	4.924; 3.922; -.379; .345; 5.339; 4.348	0.457
SECONDARY Change in Salivary Progesterone (pg/ml)	247.165; 160.933; 197.625; 198.469	0.415

Summary

The impact of well-known risk factors for such disorders (stress, biological sex, anxiety-related dispositions) on fear generalization will be examined. Findings from this study may provide insight into how these risk factors influence the development and/or maintenance of psychological disorders that involve overgeneralization of fear and could facilitate future approaches to their treatment.

Eligibility Criteria

Inclusion Criteria

18 years of age
Registered student at Ohio Northern University in Ada, Ohio

Exclusion Criteria

Regular use of tobacco or recreational drugs (e.g., marijuana, cocaine, heroin, etc.)
Previous diagnosis of Raynaud's disease or peripheral vascular disease
Previous diagnosis of skin diseases (e.g., severe psoriasis, eczema, scleroderma)
History of syncope or vasovagal response to stress
History of any heart conditions or cardiovascular issues (e.g., high blood pressure)
History of severe head trauma
Current treatment with narcotics, beta-blockers, or steroids
Previous diagnosis of substance use disorder
Regular nightshift work
Hearing loss
Consumed alcohol in past 24 hours
Engaged in strenuous exercise in past 24 hours
Ate or drank anything but water in past 2 hours

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03786952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.