Stress, PsychologicalNCT05026333
Cognitive and Biological Responses in Stress
A study testing Cognitive Stress Testing in people with Stress, Psychological and Anxiety, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The goal of this pilot part of the study (Step 1) is to identify the optimal population of high and low anxiety and stress individuals who will differentially respond to a laboratory stress task as measured by changes in subjective stress response (affect), cognition, attention, and biological measures (autonomic and… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Anxiety
- What is being tested?
- Cognitive Stress Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2021to 15 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian
- Female
- 18-45 years of age
- For the high perceived stress group: a PSS score of 15 or higher and a STAI-S of 39 or higher
- For the low perceived stress group: a PSS score of 8 or lower and a STAI-S score of 24 or lower
Who cannot join
- Any ongoing major medical, psychological, or psychiatric conditions and recent changes (3mo) in the use of psychoactive medications or other medications that interfere with the measured outcomes.
- Medical conditions such as current neurological, cardiovascular, hepatic, renal, autoimmune diseases, diabetes, or cancer. This includes having a current or past within 1 year diagnosis of GI disorders, including but not limited to IBS, IBD, Celiac, or other nutritional deficiency/disease, current eating disorder, or past weight loss surgery.
- Psychological conditions such as anxiety and depression (I.e., without history of Diagnostic and Statistical Manual (DSM-4) psychiatric diagnosis.
- Prior/Concomitant Therapy (e.g., Recent changes in the use of psychoactive medications or other medications that interfere with the measured outcomes, as determined by the PI).
- Subject involved in any other clinical study within the preceding month or in the exclusion period after another clinical study.
- Positive test for COVID-19 infection in the past month or if presenting symptoms of COVID-19 infection in the past 2 weeks.
Show all 32Show fewer
- Diet:
- Participant who changes her dietary habits within the preceding 4 weeks.
- Participants on probiotics will be asked to wait 1 month before enrollment in the study.
- Participant with an eating disorder.
- Participant with special medicated diet (e.g., for obesity, anorexia, metabolic pathology).
- Participant under artificial nutrition in the last 1 month.
- Participant planning to modify her dietary habits during the course of the study.
- Other Exclusions:
- Pregnant women or women planning to become pregnant during the study; breast-feeding women based on the interview at screen (Visit 1) and the urine test on day of stress test (Visit 2).
- Smoker with a moderate to high level of dependence to nicotine (e.g., more than 1/2 a pack of cigarettes a day).
- Participant consuming regularly more than 3 units of alcohol per day (1 unit = 10mL or 8g).
- Participants not able to answer questionnaires by writing, whatever the reason.
- Participant with loos of liberty, by administrative or judicial decision.
- Participant who is major but with a legal guardian.
- Participant on antibiotics will be asked to wait 3 months before enrollment in the study.
- Medications not Authorized:
- Opiates/Narcotics
- Chronic/Daily use of analgesics
- Anti-seizure meds
- Antidepressants (5HT3's / Tricyclics etc.) are allowed as long as it's been a stable dose for 3 months
- Medications for ADD/ADHD (I.e., Adderall)
- Any medication for appetite suppression
- Chronic use of laxative/antidiarrheals/medications affecting GI motility
- Insulin
- Bile acid sequestrants
- Use of centrally acting medications that will interfere with CNS testing
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Pilot Study Aimed to Determine the Optimal Design for the UCLA/Danone Probiotic Intervention Study Related to Stress
The goal of this pilot part of the study (Step 1) is to identify the optimal population of high and low anxiety and stress individuals who will differentially respond to a laboratory stress task as measured by changes in subjective stress response (affect), cognition, attention, and biological measures (autonomic and metabolite responses).
Based on experience with different study populations, the investigator's believe that a healthy, homogenous population (Caucasian, women, premenopausal) with higher levels of state anxiety and perceived stress, and with greater responsiveness to laboratory stress tasks (which can also be used in the probiotic intervention study in Step 2) will provide the highest likelihood of identifying the underlying central mechanisms of stress responsiveness in Step 1 and then for the probiotic intervention in Step 2.
Read more
For this pilot study, the investigator's will look at baseline measures to determine differences in responses to four subjective (affect/cognition/attention) stress tasks (primary endpoints) and biological (secondary endpoints) measures in a high stress group and a low stress group.
If for Step 1 of the study, the investigator's are able to verify the stratification of the participants into high and low stress groups based on questionnaire data and show differences between participants with high and low perceived stress in psychological characteristics, lab stress tasks and potentially in biological responses, this will help to determine the optimal cut off values, and the optimal stress tasks to be conducted in the planned probiotic intervention study of Step 2.
- Conditions
- Stress, Psychological, Anxiety
- Being tested
- Cognitive Stress Testing
- Keywords
- stress, women, high stress, low stress, perceived stress
- Medical subject headings
- Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Stress TestingOther
Also called ANS testing, metabolites, cognitive tasks, stress tasks
Cognitive and stress study with no product intervention and noninvasive. The high stress/anxiety group will be compared to the low stress/anxiety group in terms of changes from baseline to after the cognitive and stress tests (i.e., 4 laboratory tasks) and metabolite measures.
| Study group | Role | What they receive |
|---|---|---|
| High Stress Group | Experimental | Group of high stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale. Receives: Other: Cognitive Stress Testing |
| Low Stress Group | Experimental | Group of low stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale. Receives: Other: Cognitive Stress Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Subjective Stress Response
Between group differences in pre-and post- of the "overall" negative and positive affect subscale scores from the Positive Affect and Negative Affect Scale (PANAS) administered at baseline immediately before and after the 4 brief and well validated laboratory stress tasks. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.
Measured: Pre and Post laboratory testing during the in-clinic visit lasting 2-4 hours.
Secondary outcomes (7)
Differences in Attention/Executive Function
Between and within group differences on the time it takes to complete the Color Stroop attention/executive function lab stress task.
Measured: Throughout the Color Stroop laboratory test at the in-clinic visit lasting approximately 30 minutes.
Differences in Emotional Arousal System
Between and within group differences in valence and emotional arousal ratings during the IAPS task.
Measured: Throughout the IAPS laboratory test during the in-clinic visit lasting approximately 30 minutes.
Differences in Subjective Stress Response
Between and within group differences on the negative affect subscale from the Brief Positive Affect and Negative Affect Scale (PANAS) before and after the arithmetic task. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.
Measured: Pre and Post the arithmetic stress task during the in-clinic visit lasting approximately 30 minutes.
Changes in Autonomic Measures - Heart Rate Variability
Between and within group differences in overall average change in heart rate variability pre and post each laboratory stress task.
Measured: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
Differences in Attention/Executive Function
Between and within group differences on the time it takes to complete the Trails A and B attention/executive function lab stress task.
Measured: Throughout the Trails A & B laboratory tests at the in-clinic visit lasting approximately 30 minutes.
Changes in Autonomic Measures - diastolic and systolic blood pressure
Between and within group differences in overall average change in both diastolic and systolic blood pressure pre and post each laboratory stress task.
Measured: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
Changes in Autonomic Measures - Skin Conductance
Between and within group differences in overall average change in skin conductance pre and post each laboratory stress task.
Measured: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start25 Jun 2021
- Primary completion15 Jul 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (62)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups (high stress/anxiety compared to low stress/anxiety) will be compared on their performance on within laboratory stress and cognitive tasks (4 different tests).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Danone Nutricia Research
- Responsible party
- Principal investigator, Arpana Gupta, University of California, Los Angeles
- Investigators
- Arpana Gupta, PhD, Principal investigator, The Regents of the University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026333
- Sponsor's protocol ID
- IRB # 20-001921
- Status last verified
- Oct 2022
- First submitted
- 10 Aug 2021
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time there is no plan to make the de-identified data available for sharing with other researchers
Publications
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Berthoud HR. Interactions between the "cognitive" and "metabolic" brain in the control of food intake. Physiol Behav. 2007 Aug 15;91(5):486-98. doi: 10.1016/j.physbeh.2006.12.016. Epub 2007 Jan 12.
PubMed 17307205Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Murphy KJ, Hodges TE, Sheppard PAS, Troyer AK, Hampson E, Galea LAM. Sex differences in cortisol and memory following acute social stress in amnestic mild cognitive impairment. J Clin Exp Neuropsychol. 2020 Nov;42(9):881-901. doi: 10.1080/13803395.2020.1825633. Epub 2020 Oct 6.
PubMed 33023371Helminen EC, Morton ML, Wang Q, Felver JC. Stress Reactivity to the Trier Social Stress Test in Traditional and Virtual Environments: A Meta-Analytic Comparison. Psychosom Med. 2021 Apr 1;83(3):200-211. doi: 10.1097/PSY.0000000000000918.
PubMed 33534392Wheelock MD, Goodman AM, Harnett NG, Wood KH, Mrug S, Granger DA, Knight DC. Sex-related Differences in Stress Reactivity and Cingulum White Matter. Neuroscience. 2021 Apr 1;459:118-128. doi: 10.1016/j.neuroscience.2021.02.014. Epub 2021 Feb 13.
PubMed 33588003Olfert MD, Barr ML, Charlier CC, Greene GW, Zhou W, Colby SE. Sex Differences in Lifestyle Behaviors among U.S. College Freshmen. Int J Environ Res Public Health. 2019 Feb 7;16(3):482. doi: 10.3390/ijerph16030482.
PubMed 30736399Luque B, Castillo-Mayen R, Cuadrado E, Gutierrez-Domingo T, Rubio SJ, Arenas A, Delgado-Lista J, Perez Martinez P, Tabernero C. The Role of Emotional Regulation and Affective Balance on Health Perception in Cardiovascular Disease Patients According to Sex Differences. J Clin Med. 2020 Sep 30;9(10):3165. doi: 10.3390/jcm9103165.
PubMed 33007817Marin IA, Goertz JE, Ren T, Rich SS, Onengut-Gumuscu S, Farber E, Wu M, Overall CC, Kipnis J, Gaultier A. Microbiota alteration is associated with the development of stress-induced despair behavior. Sci Rep. 2017 Mar 7;7:43859. doi: 10.1038/srep43859.
PubMed 28266612Schneider TR, Rench TA, Lyons JB, Riffle RR. The influence of neuroticism, extraversion and openness on stress responses. Stress Health. 2012 Apr;28(2):102-10. doi: 10.1002/smi.1409. Epub 2011 Jun 15.
PubMed 22281953Cohen S, Janicki-Deverts D, Doyle WJ, Miller GE, Frank E, Rabin BS, Turner RB. Chronic stress, glucocorticoid receptor resistance, inflammation, and disease risk. Proc Natl Acad Sci U S A. 2012 Apr 17;109(16):5995-9. doi: 10.1073/pnas.1118355109. Epub 2012 Apr 2.
PubMed 22474371Villada C, Hidalgo V, Almela M, Salvador A. Individual Differences in the Psychobiological Response to Psychosocial Stress (Trier Social Stress Test): The Relevance of Trait Anxiety and Coping Styles. Stress Health. 2016 Apr;32(2):90-9. doi: 10.1002/smi.2582. Epub 2014 Jun 11.
PubMed 24916722Walter S, Kessler H, Gruss S, Jerg-Bretzke L, Scheck A, Strobel J, Hoffmann H, Traue HC. The influence of neuroticism and psychological symptoms on the assessment of images in three-dimensional emotion space. Psychosoc Med. 2011;8:Doc04. doi: 10.3205/psm000073. Epub 2011 Jun 6.
PubMed 21698089Crow AJD. Associations Between Neuroticism and Executive Function Outcomes: Response Inhibition and Sustained Attention on a Continuous Performance Test. Percept Mot Skills. 2019 Aug;126(4):623-638. doi: 10.1177/0031512519848221. Epub 2019 May 30.
PubMed 31146642
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Aimed to Determine the Optimal Design for the UCLA/Danone Probiotic Intervention Study Related to Stress
- ClinicalTrials.gov ID
- NCT05026333
- Acronym / sponsor ID
- IRB # 20-001921
- Conditions
- Stress, Psychological, Anxiety
- Keywords
- stress, women, high stress, low stress, perceived stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Danone Nutricia Research
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 30 Aug 2021 (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 goal of this pilot part of the study (Step 1) is to identify the optimal population of high and low anxiety and stress individuals who will differentially respond to a laboratory stress task as measured by changes in subjective stress response (affect), cognition, attention, and biological measures (autonomic and metabolite responses).
Based on experience with different study populations, the investigator's believe that a healthy, homogenous population (Caucasian, women, premenopausal) with higher levels of state anxiety and perceived stress, and with greater responsiveness to laboratory stress tasks (which can also be used in the probiotic intervention study in Step 2) will provide the highest likelihood of identifying the underlying central mechanisms of stress responsiveness in Step 1 and then for the probiotic intervention in Step 2.
For this pilot study, the investigator's will look at baseline measures to determine differences in responses to four subjective (affect/cognition/attention) stress tasks (primary endpoints) and biological (secondary endpoints) measures in a high stress group and a low stress group.
If for Step 1 of the study, the investigator's are able to verify the stratification of the participants into high and low stress groups based on questionnaire data and show differences between participants with high and low perceived stress in psychological characteristics, lab stress tasks and potentially in biological responses, this will help to determine the optimal cut off values, and the optimal stress tasks to be conducted in the planned probiotic intervention study of Step 2.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups (high stress/anxiety compared to low stress/anxiety) will be compared on their performance on within laboratory stress and cognitive tasks (4 different tests).
| Arm | Type | Receives |
|---|---|---|
| High Stress Group | Experimental | Other: Cognitive Stress TestingGroup of high stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale. |
| Low Stress Group | Experimental | Other: Cognitive Stress TestingGroup of low stress participants based on cutoff scores on the Perceived Stress Scale (PSS) and the STAI - State Anxiety Scale. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasian
- Female
- 18-45 years of age
- For the high perceived stress group: a PSS score of 15 or higher and a STAI-S of 39 or higher
- For the low perceived stress group: a PSS score of 8 or lower and a STAI-S score of 24 or lower
Key exclusion criteria (32 listed)
- Any ongoing major medical, psychological, or psychiatric conditions and recent changes (3mo) in the use of psychoactive medications or other medications that interfere with the measured outcomes.
- Medical conditions such as current neurological, cardiovascular, hepatic, renal, autoimmune diseases, diabetes, or cancer. This includes having a current or past within 1 year diagnosis of GI disorders, including but not limited to IBS, IBD, Celiac, or other nutritional deficiency/disease, current eating disorder, or past weight loss surgery.
- Psychological conditions such as anxiety and depression (I.e., without history of Diagnostic and Statistical Manual (DSM-4) psychiatric diagnosis.
- Prior/Concomitant Therapy (e.g., Recent changes in the use of psychoactive medications or other medications that interfere with the measured outcomes, as determined by the PI).
- Subject involved in any other clinical study within the preceding month or in the exclusion period after another clinical study.
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 |
|---|---|---|
| Cognitive Stress TestingAlso: ANS testing, metabolites, cognitive tasks, stress tasksCognitive and stress study with no product intervention and noninvasive. The high stress/anxiety group will be compared to the low stress/anxiety group in terms of changes from baseline to after the cognitive and stress tests (i.e., 4 laboratory tasks) and metabolite measures. | Other | High Stress Group, Low Stress Group |
Primary outcome
Differences in Subjective Stress Response
Time frame: Pre and Post laboratory testing during the in-clinic visit lasting 2-4 hours.
Between group differences in pre-and post- of the "overall" negative and positive affect subscale scores from the Positive Affect and Negative Affect Scale (PANAS) administered at baseline immediately before and after the 4 brief and well validated laboratory stress tasks. PANAS scores can range from 10-50 for both the positive and negative affect, with the lower scores representing lower levels of positive/negative affect, and higher scores representing higher levels of positive/negative affect.
7 secondary outcomes
Differences in Attention/Executive Function
Time frame: Throughout the Color Stroop laboratory test at the in-clinic visit lasting approximately 30 minutes.
Differences in Emotional Arousal System
Time frame: Throughout the IAPS laboratory test during the in-clinic visit lasting approximately 30 minutes.
Differences in Subjective Stress Response
Time frame: Pre and Post the arithmetic stress task during the in-clinic visit lasting approximately 30 minutes.
Changes in Autonomic Measures - Heart Rate Variability
Time frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
Differences in Attention/Executive Function
Time frame: Throughout the Trails A & B laboratory tests at the in-clinic visit lasting approximately 30 minutes.
Changes in Autonomic Measures - diastolic and systolic blood pressure
Time frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
Changes in Autonomic Measures - Skin Conductance
Time frame: Throughout each laboratory test during the in-clinic visit lasting 2-4 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 17307205Berthoud HR. Interactions between the "cognitive" and "metabolic" brain in the control of food intake. Physiol Behav. 2007 Aug 15;91(5):486-98. doi: 10.1016/j.physbeh.2006.12.016. Epub 2007 Jan 12.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 33023371Murphy KJ, Hodges TE, Sheppard PAS, Troyer AK, Hampson E, Galea LAM. Sex differences in cortisol and memory following acute social stress in amnestic mild cognitive impairment. J Clin Exp Neuropsychol. 2020 Nov;42(9):881-901. doi: 10.1080/13803395.2020.1825633. Epub 2020 Oct 6.
- Background: PubMed 33534392Helminen EC, Morton ML, Wang Q, Felver JC. Stress Reactivity to the Trier Social Stress Test in Traditional and Virtual Environments: A Meta-Analytic Comparison. Psychosom Med. 2021 Apr 1;83(3):200-211. doi: 10.1097/PSY.0000000000000918.
- Background: PubMed 33588003Wheelock MD, Goodman AM, Harnett NG, Wood KH, Mrug S, Granger DA, Knight DC. Sex-related Differences in Stress Reactivity and Cingulum White Matter. Neuroscience. 2021 Apr 1;459:118-128. doi: 10.1016/j.neuroscience.2021.02.014. Epub 2021 Feb 13.
- Background: PubMed 30736399Olfert MD, Barr ML, Charlier CC, Greene GW, Zhou W, Colby SE. Sex Differences in Lifestyle Behaviors among U.S. College Freshmen. Int J Environ Res Public Health. 2019 Feb 7;16(3):482. doi: 10.3390/ijerph16030482.
- Background: PubMed 33007817Luque B, Castillo-Mayen R, Cuadrado E, Gutierrez-Domingo T, Rubio SJ, Arenas A, Delgado-Lista J, Perez Martinez P, Tabernero C. The Role of Emotional Regulation and Affective Balance on Health Perception in Cardiovascular Disease Patients According to Sex Differences. J Clin Med. 2020 Sep 30;9(10):3165. doi: 10.3390/jcm9103165.
- Background: PubMed 28266612Marin IA, Goertz JE, Ren T, Rich SS, Onengut-Gumuscu S, Farber E, Wu M, Overall CC, Kipnis J, Gaultier A. Microbiota alteration is associated with the development of stress-induced despair behavior. Sci Rep. 2017 Mar 7;7:43859. doi: 10.1038/srep43859.
- Background: PubMed 22281953Schneider TR, Rench TA, Lyons JB, Riffle RR. The influence of neuroticism, extraversion and openness on stress responses. Stress Health. 2012 Apr;28(2):102-10. doi: 10.1002/smi.1409. Epub 2011 Jun 15.
- Background: PubMed 22474371Cohen S, Janicki-Deverts D, Doyle WJ, Miller GE, Frank E, Rabin BS, Turner RB. Chronic stress, glucocorticoid receptor resistance, inflammation, and disease risk. Proc Natl Acad Sci U S A. 2012 Apr 17;109(16):5995-9. doi: 10.1073/pnas.1118355109. Epub 2012 Apr 2.
- Individual participant dataSharing planned: No. At this time there is no plan to make the de-identified data available for sharing with other researchers
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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.
Arpana Gupta, PhD principal investigator
The Regents of the University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Stress Testing in people with Stress, Psychological and Anxiety, run by University of California, Los Angeles 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 5 inclusion and 32 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 12 Oct 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Differences in Subjective Stress Response (time frame: Pre and Post laboratory testing during the in-clinic visit lasting 2-4 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05026333, which also lists 62 linked publications.
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 12 Oct 2022.