Psychological StressNCT03786952
Stress, Sex, and the Generalization of Fear
A study testing Stress immediately before learning in males, Stress 30 minutes before learning in males and Stress immediately before learning in females in people with Psychological Stress, run by Ohio Northern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Stress immediately before learning in males, Stress 30 minutes before learning in males and Stress immediately before learning in females
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 606 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age
- Registered student at Ohio Northern University in Ada, Ohio
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Many researchers approach the etiology of trauma-, stressor-, and anxiety-related mental disorders from the perspective of classical conditioning processes gone awry. According to this view, abnormal associative relationships between neutral, conditioned stimuli (CSs) and aversive, unconditioned stimuli (USs) underlie pathological anxiety and result in unusually intense fear memories or fear memories that cannot be properly extinguished. Recent work has expanded this view by showing that many psychological disorders involving pathological anxiety are associated with an exaggerated form of the commonly adaptive classical conditioning phenomenon, stimulus generalization, leading individuals with such disorders to respond with fear and anxiety to a variety of environmental contexts and cues that should not be threatening. Few studies have been conducted in humans to better understand the process of fear generalization, and factors that might influence susceptibility to overgeneralize fear have yet to be assessed. It is well-known that stress, biological sex, and anxiety-related dispositions of an individual increase one's susceptibility for pathological anxiety and significantly impact fear learning; thus, it is possible that such factors, alone or in combination, contribute to clinical anxiety by influencing fear generalization processes. Aim 1 of the present study is to determine the effects of acute stress and its physiological correlates on fear generalization in human participants. Because acute stress profoundly impacts cognitive brain areas that underlie generalization, it is predicted that acute stress will enhance or impair fear generalization, depending on when the stressor is administered relative to fear learning. Aim 2 is to assess the role of biological sex in fear generalization and acute stress-induced changes in such processes. Females are more likely than males to develop several psychological disorders that involve pathological anxiety, and research has consistently reported sex-related differences in fear learning and stress-induced alterations of fear learning, effects that have been associated with ovarian hormones. Thus, it is predicted that females will exhibit greater fear generalization than males that will be impacted differently by stress. It is also hypothesized that the observed effects will correlate with estradiol and progesterone in females. The final aim of this project (Aim 3) is to evaluate the relationship between childhood stress, dispositional anxiety, and fear generalization. Early life stress has been repeatedly associated with altered stress responses and the development of anxiety-related phenotypes, yet the influence of childhood stress and trait anxiety on fear generalization have yet to be examined. This study will be the first to examine how several factors that are known to increase susceptibility for trauma-, stressor, and anxiety-related psychological disorders impact fear generalization in human subjects. The resulting findings will provide important insight into the etiology of such disorders, which could aid future approaches to their treatment.
- Conditions
- Psychological Stress
- Being tested
- Stress immediately before learning in males, Sham control immediately before learning in males, Stress 30 minutes before learning in males, Sham control 30 minutes before learning in males, Stress immediately before learning in females
- Keywords
- stress, sex, fear, generalization, cortisol, alpha-amylase, estradiol, progesterone
- Medical subject headings
- Stress, Psychological, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress immediately before learning in malesBehavioural
Male participants will be exposed to the socially evaluated cold pressor test immediately prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Immediately following the acute stressor, participants will undergo the acquisition phase of fear conditioning.
Sham control immediately before learning in malesBehavioural
Male participants will be exposed to the sham control condition (no stress) immediately prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Immediately following the sham control condition, participants will undergo the acquisition phase of fear conditioning.
Stress 30 minutes before learning in malesBehavioural
Male participants will be exposed to the socially evaluated cold pressor test 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Thirty minutes following the acute stressor, participants will undergo the acquisition phase of fear conditioning.
Sham control 30 minutes before learning in malesBehavioural
Male participants will be exposed to the sham control condition (no stress) 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Thirty minutes following the sham control condition, participants will undergo the acquisition phase of fear conditioning.
Stress immediately before learning in femalesBehavioural
Female participants will be exposed to the socially evaluated cold pressor test immediately prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Immediately following the acute stressor, participants will undergo the acquisition phase of fear conditioning.
Sham control immediately before learning in femalesBehavioural
Female participants will be exposed to the sham control condition (no stress) immediately prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Immediately following the sham control condition, participants will undergo the acquisition phase of fear conditioning.
Stress 30 minutes before learning in femalesBehavioural
Female participants will be exposed to the socially evaluated cold pressor test 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Thirty minutes following the acute stressor, participants will undergo the acquisition phase of fear conditioning.
Sham control 30 minutes before learning in femalesBehavioural
Female participants will be exposed to the sham control condition (no stress) 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Thirty minutes following the sham control condition, participants will undergo the acquisition phase of fear conditioning.
| Study group | Role | What they receive |
|---|---|---|
| Stress, immediate, males | Experimental | Stress immediately before learning in males Receives: Behavioral: Stress immediately before learning in males |
| Stress, delayed, males | Experimental | Stress 30 minutes before learning in males Receives: Behavioral: Stress 30 minutes before learning in males |
| Sham control, immediate, males | Sham comparator | Sham control immediately before learning in males Receives: Behavioral: Sham control immediately before learning in males |
| Sham control, delayed, males | Sham comparator | Sham control 30 minutes before learning in males Receives: Behavioral: Sham control 30 minutes before learning in males |
| Stress, immediate, females | Experimental | Stress immediately before learning in females Receives: Behavioral: Stress immediately before learning in females |
| Stress, delayed, females | Experimental | Stress 30 minutes before learning in females Receives: Behavioral: Stress 30 minutes before learning in females |
| Sham control, immediate, females | Sham comparator | Sham control immediately before learning in females Receives: Behavioral: Sham control immediately before learning in females |
| Sham control, delayed, females | Sham comparator | Sham control 30 minutes before learning in females Receives: Behavioral: Sham control 30 minutes before learning in females |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear-potentiated Startle Responses to the CS+ and CS- During Acquisition
Peak eyeblink startle responses 20-200 ms following presentation of a startle probe were measured. Startle responses were assessed for each of 3 trial types: (1) following the startle probe alone [noise alone (NA) trials], (2) following the CS+ and startle probe (CS+ trials), and (3) following the CS- and startle probe (CS- trials). Participants were exposed to 16 blocks of trials, and each block included 1 presentation of each trial type. During the last 12 blocks, CS+ trials also included the presentation of an aversive US. For each block, startle responses to NA trials were subtracted from startle responses to CS+ trials and from startle responses to CS- trials to create 2 separate fear-potentiated startle response measures: 1 for the CS+ and 1 for the CS-. Average fear-potentiated startle responses to the CS+ and CS- during the last 4 blocks of trials were used as an indicator of fear learning (greater responses to the CS+, relative to the CS-, indicated greater learning).
Measured: Average of the responses from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1
EMG Responses to CS+, CS-, and Generalization Stimuli During Generalization Testing
Peak eyeblink startle responses 20-200 ms following the presentation of a startle probe were measured. Startle responses were assessed for each of 10 trial types: (1) following the startle probe alone [noise alone (NA) trials], (2) following the CS+ and startle probe (CS+ trials), (3) following each of 7 generalization stimuli and startle probe (GS trials), and (4) following the CS- and startle probe (CS- trials). Participants were exposed to 3 blocks of trials, and each block included 1 presentation of each trial type. For each block, startle responses to the NA trials were subtracted from startle responses to the CS+, GSs, and CS- trials to create separate fear-potentiated startle response measures for each of the 9 different stimuli. Average fear-potentiated startle responses to each stimulus across all 3 blocks were used as an indicator of fear expression. Greater scores for the generalization stimuli (GS) indicated a greater generalization of fear.
Measured: Average of responses from all trials on Day 2
Skin Conductance Responses to CS+ and CS- During Acquisition
Electrodermal activity was measured following presentation of the CS+ and CS- during acquisition on Day 1. Participants were exposed to 16 blocks of trials, with each block including a single presentation of each stimulus. During the last 12 blocks, CS+ trials included the presentation of an aversive US. For each block, skin conductance responses were quantified by calculating the average increase in electrodermal activity (from a 1 s pre-stimulus baseline) 3-6 s after CS+ or CS- onset. Average skin conductance responses to the CS+ and CS- during the last 4 blocks of trials were used as an indicator of fear learning (greater responses to the CS+, relative to the CS-, indicated greater learning).
Measured: Average of the responses from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1
Skin Conductance Responses to CS+, Generalization Stimuli, and CS- During Generalization Testing
Electrodermal activity was measured following presentation of the CS+, 7 generalization stimuli (GSs), and CS- during generalization testing on Day 2. Participants were exposed to 3 blocks of trials, with each block including a single presentation of each stimulus. For each block, skin conductance responses were quantified by calculating the average increase in electrodermal activity (from a 1 s pre-stimulus baseline) 3-6 s after onset of the CS+, 7 GSs, or CS- onset.. Average skin conductance responses to each stimulus across all 3 blocks were used as an indicator of fear expression. Greater scores for the generalization stimuli (GS) indicated a greater generalization of fear.
Measured: Average of responses from all trials on Day 2
US Expectancy Ratings to CS+ and CS- During Acquisition
Participants were exposed to 16 blocks of trials, and each block included 1 presentation of the CS+ and one presentation of the CS-. During the last 12 blocks, CS+ trials included the presentation of an aversive US. During each trial, participants pressed, within 3 seconds of stimulus onset, a button marked "+" if they expected the stimulus to be followed by the US, a button marked "-" if they did not expect the stimulus to be followed by the US, or a button marked "0" if they were uncertain. For the purpose of data analysis, + was scored as +1, - were scored as -1, and 0 was scored as 0. Average expectancy ratings during the last 4 blocks of trials were used as an indicator of fear learning (greater responses to the CS+, relative to the CS-, indicated greater learning).
Measured: Average of the ratings from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1
US Expectancy Ratings to CS+, CS-, and Generalization Stimuli During Generalization Testing
Participants were exposed to 3 blocks of trials, and each block included 1 presentation of the CS+, one presentation of each of 7 generalization stimuli (GSs), and one presentation of the CS-. Participants were instructed to press, within 3 seconds of stimulus onset, a button marked "+" if they expected the stimulus to be followed by the US, a button marked "-" if they did not expect the stimulus to be followed by the US, or a button marked "0" if they were uncertain. For the purpose of data analysis, + was scored as +1, - was scored as -1, and 0 was scored as 0. Average expectancy ratings for each stimulus across all 3 blocks were used as an indicator of fear. Greater scores for the generalization stimuli (GS) indicated a greater generalization of fear.
Measured: Average of ratings from all trials on Day 2
Secondary outcomes (6)
Change in Baseline Salivary Cortisol (Nmol/l)
Saliva samples were collected from participants prior to undergoing the stress or sham control condition (baseline) and then 25 min later. The change in salivary cortisol levels was analyzed. Greater levels indicated greater cortisol responses to stress.
Measured: Day 1 (change from baseline to 25 min post-stress)
Change in Baseline Salivary Alpha-amylase (U/ml)
Saliva samples were collected from participants prior to undergoing the stress or sham control condition (baseline) and then immediately after the manipulation. The change in salivary alpha-amylase levels was analyzed. Greater levels indicated greater alpha-amylase responses to stress.
Measured: Day 1 (change from baseline to immediately after stress)
Average Subjective Pain, as Assessed by Verbal Self Report
During the stress or sham control manipulation, participants rated the painfulness of the water bath at 1-minute intervals on an 11-point scale ranging from 0-10, with 0 = lack of pain and 10 = unbearable pain. The obtained ratings were averaged and analyzed. Greater ratings indicated greater subjective pain during the stressor.
Measured: Stress or sham control condition on Day 1
Average Subjective Stress, as Assessed by Verbal Self Report
During the stress or sham control manipulation, participants rated the stressfulness of the water bath at 1-minute intervals on an 11-point scale ranging from 0-10, with 0 = lack of stress and 10 = unbearable stress. The obtained ratings were averaged and analyzed. Greater ratings indicated greater subjective stress during the stressor.
Measured: Stress or sham control condition on Day 1
Change in Heart Rate (Bpm)
Heart rate (bpm) measurements were aken via the PPG module of the Biopac MP150 system from participants prior to undergoing the stress or sham control condition (baseline) and then halfway through the manipulation.The change in heart rate was analyzed.
Measured: Day 1 (change from baseline to during stress or sham control manipulation)
Change in Salivary Progesterone (pg/ml)
Saliva samples were collected from female participants prior to undergoing the stress or sham control condition (baseline) and then 25 min later. The change in salivary progesterone levels were analyzed.
Measured: Day 1 (change from baseline to 25 min post-stress)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start25 Jan 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychological StressStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio Northern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Phillip Zoladz, Ohio Northern University
- Investigators
- Phillip Zoladz, Ph.D., Principal investigator, Ohio Northern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786952
- Sponsor's protocol ID
- 1R15MH116337-01A1
- Other IDs
- R15MH116337
- Status last verified
- Feb 2023
- First submitted
- 18 Dec 2018
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data and data from descriptive/raw measures were submitted on a semi-annual basis to the NIMH Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Sex, and the Generalization of Fear
- ClinicalTrials.gov ID
- NCT03786952
- Acronym / sponsor ID
- 1R15MH116337-01A1
- Conditions
- Psychological Stress
- Keywords
- stress, sex, fear, generalization, cortisol, alpha-amylase, estradiol, progesterone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 606 participants (actual)
- Lead sponsor
- Ohio Northern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Posted 23 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Many researchers approach the etiology of trauma-, stressor-, and anxiety-related mental disorders from the perspective of classical conditioning processes gone awry. According to this view, abnormal associative relationships between neutral, conditioned stimuli (CSs) and aversive, unconditioned stimuli (USs) underlie pathological anxiety and result in unusually intense fear memories or fear memories that cannot be properly extinguished. Recent work has expanded this view by showing that many psychological disorders involving pathological anxiety are associated with an exaggerated form of the commonly adaptive classical conditioning phenomenon, stimulus generalization, leading individuals with such disorders to respond with fear and anxiety to a variety of environmental contexts and cues that should not be threatening. Few studies have been conducted in humans to better understand the process of fear generalization, and factors that might influence susceptibility to overgeneralize fear have yet to be assessed. It is well-known that stress, biological sex, and anxiety-related dispositions of an individual increase one's susceptibility for pathological anxiety and significantly impact fear learning; thus, it is possible that such factors, alone or in combination, contribute to clinical anxiety by influencing fear generalization processes. Aim 1 of the present study is to determine the effects of acute stress and its physiological correlates on fear generalization in human participants. Because acute stress profoundly impacts cognitive brain areas that underlie generalization, it is predicted that acute stress will enhance or impair fear generalization, depending on when the stressor is administered relative to fear learning. Aim 2 is to assess the role of biological sex in fear generalization and acute stress-induced changes in such processes. Females are more likely than males to develop several psychological disorders that involve pathological anxiety, and research has consistently reported sex-related differences in fear learning and stress-induced alterations of fear learning, effects that have been associated with ovarian hormones. Thus, it is predicted that females will exhibit greater fear generalization than males that will be impacted differently by stress. It is also hypothesized that the observed effects will correlate with estradiol and progesterone in females. The final aim of this project (Aim 3) is to evaluate the relationship between childhood stress, dispositional anxiety, and fear generalization. Early life stress has been repeatedly associated with altered stress responses and the development of anxiety-related phenotypes, yet the influence of childhood stress and trait anxiety on fear generalization have yet to be examined. This study will be the first to examine how several factors that are known to increase susceptibility for trauma-, stressor, and anxiety-related psychological disorders impact fear generalization in human subjects. The resulting findings will provide important insight into the etiology of such disorders, which could aid future approaches to their treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Stress, immediate, males | Experimental | Behavioral: Stress immediately before learning in malesStress immediately before learning in males |
| Stress, delayed, males | Experimental | Behavioral: Stress 30 minutes before learning in malesStress 30 minutes before learning in males |
| Sham control, immediate, males | Sham comparator | Behavioral: Sham control immediately before learning in malesSham control immediately before learning in males |
| Sham control, delayed, males | Sham comparator | Behavioral: Sham control 30 minutes before learning in malesSham control 30 minutes before learning in males |
| Stress, immediate, females | Experimental | Behavioral: Stress immediately before learning in femalesStress immediately before learning in females |
| Stress, delayed, females | Experimental | Behavioral: Stress 30 minutes before learning in femalesStress 30 minutes before learning in females |
| Sham control, immediate, females | Sham comparator | Behavioral: Sham control immediately before learning in femalesSham control immediately before learning in females |
| Sham control, delayed, females | Sham comparator | Behavioral: Sham control 30 minutes before learning in femalesSham control 30 minutes before learning in females |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age
- Registered student at Ohio Northern University in Ada, Ohio
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| Stress immediately before learning in malesMale participants will be exposed to the socially evaluated cold pressor test immediately prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Immediately following the acute stressor, participants will undergo the acquisition phase of fear conditioning. | Behavioural | Stress, immediate, males |
| Sham control immediately before learning in malesMale participants will be exposed to the sham control condition (no stress) immediately prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Immediately following the sham control condition, participants will undergo the acquisition phase of fear conditioning. | Behavioural | Sham control, immediate, males |
| Stress 30 minutes before learning in malesMale participants will be exposed to the socially evaluated cold pressor test 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Thirty minutes following the acute stressor, participants will undergo the acquisition phase of fear conditioning. | Behavioural | Stress, delayed, males |
| Sham control 30 minutes before learning in malesMale participants will be exposed to the sham control condition (no stress) 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Thirty minutes following the sham control condition, participants will undergo the acquisition phase of fear conditioning. | Behavioural | Sham control, delayed, males |
| Stress immediately before learning in femalesFemale participants will be exposed to the socially evaluated cold pressor test immediately prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Immediately following the acute stressor, participants will undergo the acquisition phase of fear conditioning. | Behavioural | Stress, immediate, females |
| Sham control immediately before learning in femalesFemale participants will be exposed to the sham control condition (no stress) immediately prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Immediately following the sham control condition, participants will undergo the acquisition phase of fear conditioning. | Behavioural | Sham control, immediate, females |
| Stress 30 minutes before learning in femalesFemale participants will be exposed to the socially evaluated cold pressor test 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Thirty minutes following the acute stressor, participants will undergo the acquisition phase of fear conditioning. | Behavioural | Stress, delayed, females |
| Sham control 30 minutes before learning in femalesFemale participants will be exposed to the sham control condition (no stress) 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Thirty minutes following the sham control condition, participants will undergo the acquisition phase of fear conditioning. | Behavioural | Sham control, delayed, females |
Primary outcome
Fear-potentiated Startle Responses to the CS+ and CS- During Acquisition
Time frame: Average of the responses from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1
Peak eyeblink startle responses 20-200 ms following presentation of a startle probe were measured. Startle responses were assessed for each of 3 trial types: (1) following the startle probe alone [noise alone (NA) trials], (2) following the CS+ and startle probe (CS+ trials), and (3) following the CS- and startle probe (CS- trials). Participants were exposed to 16 blocks of trials, and each block included 1 presentation of each trial type. During the last 12 blocks, CS+ trials also included the presentation of an aversive US. For each block, startle responses to NA trials were subtracted from startle responses to CS+ trials and from startle responses to CS- trials to create 2 separate fear-potentiated startle response measures: 1 for the CS+ and 1 for the CS-. Average fear-potentiated startle responses to the CS+ and CS- during the last 4 blocks of trials were used as an indicator of fear learning (greater responses to the CS+, relative to the CS-, indicated greater learning).
EMG Responses to CS+, CS-, and Generalization Stimuli During Generalization Testing
Time frame: Average of responses from all trials on Day 2
Peak eyeblink startle responses 20-200 ms following the presentation of a startle probe were measured. Startle responses were assessed for each of 10 trial types: (1) following the startle probe alone [noise alone (NA) trials], (2) following the CS+ and startle probe (CS+ trials), (3) following each of 7 generalization stimuli and startle probe (GS trials), and (4) following the CS- and startle probe (CS- trials). Participants were exposed to 3 blocks of trials, and each block included 1 presentation of each trial type. For each block, startle responses to the NA trials were subtracted from startle responses to the CS+, GSs, and CS- trials to create separate fear-potentiated startle response measures for each of the 9 different stimuli. Average fear-potentiated startle responses to each stimulus across all 3 blocks were used as an indicator of fear expression. Greater scores for the generalization stimuli (GS) indicated a greater generalization of fear.
Skin Conductance Responses to CS+ and CS- During Acquisition
Time frame: Average of the responses from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1
Electrodermal activity was measured following presentation of the CS+ and CS- during acquisition on Day 1. Participants were exposed to 16 blocks of trials, with each block including a single presentation of each stimulus. During the last 12 blocks, CS+ trials included the presentation of an aversive US. For each block, skin conductance responses were quantified by calculating the average increase in electrodermal activity (from a 1 s pre-stimulus baseline) 3-6 s after CS+ or CS- onset. Average skin conductance responses to the CS+ and CS- during the last 4 blocks of trials were used as an indicator of fear learning (greater responses to the CS+, relative to the CS-, indicated greater learning).
Skin Conductance Responses to CS+, Generalization Stimuli, and CS- During Generalization Testing
Time frame: Average of responses from all trials on Day 2
Electrodermal activity was measured following presentation of the CS+, 7 generalization stimuli (GSs), and CS- during generalization testing on Day 2. Participants were exposed to 3 blocks of trials, with each block including a single presentation of each stimulus. For each block, skin conductance responses were quantified by calculating the average increase in electrodermal activity (from a 1 s pre-stimulus baseline) 3-6 s after onset of the CS+, 7 GSs, or CS- onset.. Average skin conductance responses to each stimulus across all 3 blocks were used as an indicator of fear expression. Greater scores for the generalization stimuli (GS) indicated a greater generalization of fear.
US Expectancy Ratings to CS+ and CS- During Acquisition
Time frame: Average of the ratings from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1
Participants were exposed to 16 blocks of trials, and each block included 1 presentation of the CS+ and one presentation of the CS-. During the last 12 blocks, CS+ trials included the presentation of an aversive US. During each trial, participants pressed, within 3 seconds of stimulus onset, a button marked "+" if they expected the stimulus to be followed by the US, a button marked "-" if they did not expect the stimulus to be followed by the US, or a button marked "0" if they were uncertain. For the purpose of data analysis, + was scored as +1, - were scored as -1, and 0 was scored as 0. Average expectancy ratings during the last 4 blocks of trials were used as an indicator of fear learning (greater responses to the CS+, relative to the CS-, indicated greater learning).
US Expectancy Ratings to CS+, CS-, and Generalization Stimuli During Generalization Testing
Time frame: Average of ratings from all trials on Day 2
Participants were exposed to 3 blocks of trials, and each block included 1 presentation of the CS+, one presentation of each of 7 generalization stimuli (GSs), and one presentation of the CS-. Participants were instructed to press, within 3 seconds of stimulus onset, a button marked "+" if they expected the stimulus to be followed by the US, a button marked "-" if they did not expect the stimulus to be followed by the US, or a button marked "0" if they were uncertain. For the purpose of data analysis, + was scored as +1, - was scored as -1, and 0 was scored as 0. Average expectancy ratings for each stimulus across all 3 blocks were used as an indicator of fear. Greater scores for the generalization stimuli (GS) indicated a greater generalization of fear.
6 secondary outcomes
Change in Baseline Salivary Cortisol (Nmol/l)
Time frame: Day 1 (change from baseline to 25 min post-stress)
Change in Baseline Salivary Alpha-amylase (U/ml)
Time frame: Day 1 (change from baseline to immediately after stress)
Average Subjective Pain, as Assessed by Verbal Self Report
Time frame: Stress or sham control condition on Day 1
Average Subjective Stress, as Assessed by Verbal Self Report
Time frame: Stress or sham control condition on Day 1
Change in Heart Rate (Bpm)
Time frame: Day 1 (change from baseline to during stress or sham control manipulation)
Change in Salivary Progesterone (pg/ml)
Time frame: Day 1 (change from baseline to 25 min post-stress)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Raw data and data from descriptive/raw measures were submitted on a semi-annual basis to the NIMH Data Archive
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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. This study is not recruiting at the moment.
Phillip Zoladz, Ph.D. principal investigator
Ohio Northern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress immediately before learning in males, Stress 30 minutes before learning in males and Stress immediately before learning in females in people with Psychological Stress, run by Ohio Northern University at 1 site in United States.
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 2 inclusion and 13 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: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear-potentiated Startle Responses to the CS+ and CS- During Acquisition (time frame: Average of the responses from trial block 13, trial block 14, trial block 15, and trial block 16 on Day 1). The study lists 6 primary outcomes in all. 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 23 Mar 2023.