Stress, PsychologicalMACEStressNCT06152549
Online Emotional Response to Completing a Childhood Maltreatment Self-report Scale
An observational study of Stress, Psychological and Stress, Emotional, run by Mclean Hospital at 1 site in United States.
Trial summary
Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Stress, Emotional
- What is being tested?
- Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge, Standardized Maths and Verbal Questions such as the ones used in SATs and Chronology of Perceived Discrimination Scale (CPDS)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2022to 30 Dec 2023
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Data will be collected online from participants across the USA. The study will include representative national sample (by age, sex, and ethnicity) of healthy volunteers, from the United States (total N=500) and will be conducted via Prolific™, which maintains a pool of research participants specifically interested in participating in online behavioral or psychological research studies.
Who may be able to join
- Healthy volunteers ages 18-65, living full-time in the U.S at the time of participation in the study.
Who cannot join
- Below 18 or above 65. Living outside the U.S at the time of participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
McLean Hospital through ProlificTM
Belmont, Massachusetts, 02478
About this study
Official title: Assessing the Emotional and Physiological Response of Adults to Completing a Self-report Scale on Exposure to Childhood Maltreatment - Online Component
Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders. It has been estimated that adverse childhood experiences account for 45%, 50%, 64% and 67% of the population attributable risk for childhood onset psychiatric disorders, alcoholism, depression, substance abuse and suicide attempts. There is also increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differently to treatment. The investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention, targeted treatment and research. A potential barrier to the widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions, particularly on an online questionnaire, may provoke untoward reactions and create clinical problems.
Therefore, the investigators have designed this observational study to test our hypothesis that answering questions about type and timing of childhood maltreatment are no more stressful than answering standardized mathematical and verbal questions, of the type asked on the Scholastic Aptitude Test (SAT).
Read more
The study will include representative national samples (by age, sex, and ethnicity) from the United States (total N=500, Ages 18-65) and will be conducted online via Prolific™, which maintains a pool of research participants.
Participants will be assigned randomly to one of two test sequences.
- In sequence 1, the Maltreatment and Abuse Chronology of Exposure (MACE) scale will be presented toward the beginning of the session and the Math/Verbal Test toward the end.
- In sequence 2, the order will be reversed.
The impact of completing the MACE and standardized IQ questions will be assessed before and after each module, using the abbreviated form of the Profile of Mood States (POMS).
Read the detailed description
Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders. Briefly, it has been estimated that adverse childhood experiences account for 45%, 50%, 54%, 64% and 67% of the population attributable risk for childhood onset psychiatric disorders, alcoholism, depression, substance abuse and suicide attempts, respectively. Maltreatment is also associated with increased risk for heart disease, cancer, chronic lung disease, liver disease, and shortened life span. There is increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differentially to treatment. Hence, the investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention, targeted treatment, and research.
However, a potential barrier to widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions, particularly on an online questionnaire, may provoke untoward reactions and create clinical problems. To date, the investigators have collected maltreatment data on over 3000 participants without a single call from participants about feeling distressed. While some IRBs permit collection of this information online, the investigators are aware of colleagues at other universities who have had their request denied.
Our thought is that whatever human subjects' limitations should be imposed on collecting childhood maltreatment data via self-report should not simply be a matter of opinion but should be based on evidence.
Hence, the investigators are proposing to specifically study the acute emotional response of volunteer participants, especially those with a history of self-reported childhood maltreatment, to completing a detailed self-report instrument on type and timing of exposure to childhood maltreatment. For contrast, the investigators will also compare their response to completing a series of mathematical and verbal questions, of the type asked on the Scholastic Aptitude Test (SAT), as an example of the type of questions that can be asked without human subject approval.
Our primary hypothesis is that endeavoring to answer these questions will be more stressful and emotionally provocative than questions regarding history of childhood maltreatment, even in participants who report moderate-to-high levels of childhood maltreatment.
- Conditions
- Stress, Psychological, Stress, Emotional
- Being tested
- Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge, Standardized Maths and Verbal Questions such as the ones used in SATs, Chronology of Perceived Discrimination Scale (CPDS), International Personality Item Pool (IPIP-NEO)
- Keywords
- childhood maltreatment,, adverse childhood experiences, standardized math and verbal tests
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maltreatment and Abuse Chronology of Exposure Scale as a stress challengeBehavioural
The first group (N=250) will receive the Maltreatment and Abuse Chronology of Exposure (MACE) scale first, to assess early life adversity, followed by the standardized test questions. A POMS will be administered before each challenge.
Standardized Maths and Verbal Questions such as the ones used in SATsBehavioural
The second group (N=250) will be presented with the standardized test questions (Math/Verbal) to assess their stress level, measured through POMS, followed by the Maltreatment and Abuse Chronology of Exposure (MACE) scale.
Chronology of Perceived Discrimination Scale (CPDS)Behavioural
The group will also receive the Chronology of Perceived Discrimination Scale (CPDS) to assess type and timing of perceived discrimination during the first 18 years of life. A POMS will be administered before and after the intervention/challenge.
International Personality Item Pool (IPIP-NEO)Behavioural
Participants in both groups will be presented with the abbreviated version of the IPIP-NEO a personality questionnaire that provides ratings on the Five Factor Personality Model. The research team sees this task as non-stressful and even potentially soothing and envisions that it will help to restore an individual's mood before taking the next stressful test and again at the completion of the online session.
| Study group | Role | What they receive |
|---|---|---|
| MACE First Group | This group (N=250) will be presented with the Maltreatment and Abuse Chronology of Exposure (MACE) scale toward the beginning of the session and the Math/Verbal Test toward the end. Receives: Behavioral: Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge; Behavioral: Standardized Maths and Verbal Questions such as the ones used in SATs; Behavioral: Chronology of Perceived Discrimination Scale (CPDS); Behavioral: International Personality Item Pool (IPIP-NEO) | |
| Standardized Test Questions First Group | This group (N=250) will be presented with the standardized test questions (Math/Verbal) toward the beginning of the session and the Maltreatment and Abuse Chronology of Exposure (MACE) scale toward the end. Receives: Behavioral: Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge; Behavioral: Standardized Maths and Verbal Questions such as the ones used in SATs; Behavioral: Chronology of Perceived Discrimination Scale (CPDS); Behavioral: International Personality Item Pool (IPIP-NEO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Mood States (POMS)
The abbreviated form of the POMS(40-items) provides ratings of anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, friendliness and a total mood disturbance score. It takes only 3-5 minutes to complete. Items are scored as Not at all(0), A little(1), Moderately(2), Quite a lot(3), Extremely(4). Scores for the seven subscales in the abbreviated POMS are calculated by summing the numerical ratings for items that contribute to each subscale, with two items "Ashamed" and "Embarrassed" reverse scored.
Measured: Through study completion, an average of 90 mins
Total Mood Disturbance (TMD)
Total Mood Disturbance (TMD) is calculated by summing the totals for the POMS negative subscales and then subtracting the totals for the POMS positive subscales.
The formula is as follows:
TMD = [Tension+Depression+Anger+Fatigue+Confusion] - [Vigor+Esteem-related Affect]
Measured: Through study completion, an average of 90 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start15 Oct 2022
- Primary completion15 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin H Teicher, Mclean Hospital
- Investigators
- Martin H Teicher, MD,PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152549
- Sponsor's protocol ID
- 401730
- Acronym
- MACEStress
- Status last verified
- Mar 2024
- First submitted
- 7 Dec 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anda RF, Brown DW, Dube SR, Bremner JD, Felitti VJ, Giles WH. Adverse childhood experiences and chronic obstructive pulmonary disease in adults. Am J Prev Med. 2008 May;34(5):396-403. doi: 10.1016/j.amepre.2008.02.002.
PubMed 18407006Anda RF, Whitfield CL, Felitti VJ, Chapman D, Edwards VJ, Dube SR, Williamson DF. Adverse childhood experiences, alcoholic parents, and later risk of alcoholism and depression. Psychiatr Serv. 2002 Aug;53(8):1001-9. doi: 10.1176/appi.ps.53.8.1001.
PubMed 12161676Brown DW, Anda RF, Felitti VJ, Edwards VJ, Malarcher AM, Croft JB, Giles WH. Adverse childhood experiences are associated with the risk of lung cancer: a prospective cohort study. BMC Public Health. 2010 Jan 19;10:20. doi: 10.1186/1471-2458-10-20.
PubMed 20085623Brown DW, Anda RF, Tiemeier H, Felitti VJ, Edwards VJ, Croft JB, Giles WH. Adverse childhood experiences and the risk of premature mortality. Am J Prev Med. 2009 Nov;37(5):389-96. doi: 10.1016/j.amepre.2009.06.021.
PubMed 19840693Dong M, Dube SR, Felitti VJ, Giles WH, Anda RF. Adverse childhood experiences and self-reported liver disease: new insights into the causal pathway. Arch Intern Med. 2003 Sep 8;163(16):1949-56. doi: 10.1001/archinte.163.16.1949.
PubMed 12963569Dong M, Giles WH, Felitti VJ, Dube SR, Williams JE, Chapman DP, Anda RF. Insights into causal pathways for ischemic heart disease: adverse childhood experiences study. Circulation. 2004 Sep 28;110(13):1761-6. doi: 10.1161/01.CIR.0000143074.54995.7F. Epub 2004 Sep 20.
PubMed 15381652Dube SR, Anda RF, Felitti VJ, Chapman DP, Williamson DF, Giles WH. Childhood abuse, household dysfunction, and the risk of attempted suicide throughout the life span: findings from the Adverse Childhood Experiences Study. JAMA. 2001 Dec 26;286(24):3089-96. doi: 10.1001/jama.286.24.3089.
PubMed 11754674Dube SR, Felitti VJ, Dong M, Chapman DP, Giles WH, Anda RF. Childhood abuse, neglect, and household dysfunction and the risk of illicit drug use: the adverse childhood experiences study. Pediatrics. 2003 Mar;111(3):564-72. doi: 10.1542/peds.111.3.564.
PubMed 12612237Dube SR, Felitti VJ, Dong M, Giles WH, Anda RF. The impact of adverse childhood experiences on health problems: evidence from four birth cohorts dating back to 1900. Prev Med. 2003 Sep;37(3):268-77. doi: 10.1016/s0091-7435(03)00123-3.
PubMed 12914833Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
PubMed 9635069Gordis EB, Granger DA, Susman EJ, Trickett PK. Salivary alpha amylase-cortisol asymmetry in maltreated youth. Horm Behav. 2008 Jan;53(1):96-103. doi: 10.1016/j.yhbeh.2007.09.002. Epub 2007 Sep 12.
PubMed 17945232Green JG, McLaughlin KA, Berglund PA, Gruber MJ, Sampson NA, Zaslavsky AM, Kessler RC. Childhood adversities and adult psychiatric disorders in the national comorbidity survey replication I: associations with first onset of DSM-IV disorders. Arch Gen Psychiatry. 2010 Feb;67(2):113-23. doi: 10.1001/archgenpsychiatry.2009.186.
PubMed 20124111Heim C, Newport DJ, Mletzko T, Miller AH, Nemeroff CB. The link between childhood trauma and depression: insights from HPA axis studies in humans. Psychoneuroendocrinology. 2008 Jul;33(6):693-710. doi: 10.1016/j.psyneuen.2008.03.008.
PubMed 18602762Kirschbaum C, Pirke KM, Hellhammer DH. The 'Trier Social Stress Test'--a tool for investigating psychobiological stress responses in a laboratory setting. Neuropsychobiology. 1993;28(1-2):76-81. doi: 10.1159/000119004.
PubMed 8255414Monteleone AM, Patriciello G, Ruzzi V, Cimino M, Giorno CD, Steardo L Jr, Monteleone P, Maj M. Deranged emotional and cortisol responses to a psychosocial stressor in anorexia nervosa women with childhood trauma exposure: Evidence for a "maltreated ecophenotype"? J Psychiatr Res. 2018 Sep;104:39-45. doi: 10.1016/j.jpsychires.2018.06.013. Epub 2018 Jun 19.
PubMed 29936175
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Emotional and Physiological Response of Adults to Completing a Self-report Scale on Exposure to Childhood Maltreatment - Online Component
- ClinicalTrials.gov ID
- NCT06152549
- Acronym / sponsor ID
- MACEStress / 401730
- Conditions
- Stress, Psychological, Stress, Emotional
- Keywords
- childhood maltreatment,, adverse childhood experiences, standardized math and verbal tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 30 Nov 2023 (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.
Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders. It has been estimated that adverse childhood experiences account for 45%, 50%, 64% and 67% of the population attributable risk for childhood onset psychiatric disorders, alcoholism, depression, substance abuse and suicide attempts. There is also increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differently to treatment. The investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention, targeted treatment and research. A potential barrier to the widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions, particularly on an online questionnaire, may provoke untoward reactions and create clinical problems.
Therefore, the investigators have designed this observational study to test our hypothesis that answering questions about type and timing of childhood maltreatment are no more stressful than answering standardized mathematical and verbal questions, of the type asked on the Scholastic Aptitude Test (SAT).
The study will include representative national samples (by age, sex, and ethnicity) from the United States (total N=500, Ages 18-65) and will be conducted online via Prolific™, which maintains a pool of research participants.
Participants will be assigned randomly to one of two test sequences.
- In sequence 1, the Maltreatment and Abuse Chronology of Exposure (MACE) scale will be presented toward the beginning of the session and the Math/Verbal Test toward the end.
- In sequence 2, the order will be reversed.
The impact of completing the MACE and standardized IQ questions will be assessed before and after each module, using the abbreviated form of the Profile of Mood States (POMS).
Detailed description
Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders. Briefly, it has been estimated that adverse childhood experiences account for 45%, 50%, 54%, 64% and 67% of the population attributable risk for childhood onset psychiatric disorders, alcoholism, depression, substance abuse and suicide attempts, respectively. Maltreatment is also associated with increased risk for heart disease, cancer, chronic lung disease, liver disease, and shortened life span. There is increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differentially to treatment. Hence, the investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention, targeted treatment, and research.
However, a potential barrier to widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions, particularly on an online questionnaire, may provoke untoward reactions and create clinical problems. To date, the investigators have collected maltreatment data on over 3000 participants without a single call from participants about feeling distressed. While some IRBs permit collection of this information online, the investigators are aware of colleagues at other universities who have had their request denied.
Our thought is that whatever human subjects' limitations should be imposed on collecting childhood maltreatment data via self-report should not simply be a matter of opinion but should be based on evidence.
Hence, the investigators are proposing to specifically study the acute emotional response of volunteer participants, especially those with a history of self-reported childhood maltreatment, to completing a detailed self-report instrument on type and timing of exposure to childhood maltreatment. For contrast, the investigators will also compare their response to completing a series of mathematical and verbal questions, of the type asked on the Scholastic Aptitude Test (SAT), as an example of the type of questions that can be asked without human subject approval.
Our primary hypothesis is that endeavoring to answer these questions will be more stressful and emotionally provocative than questions regarding history of childhood maltreatment, even in participants who report moderate-to-high levels of childhood maltreatment.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MACE First Group | – | Behavioral: Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge, Behavioral: Standardized Maths and Verbal Questions such as the ones used in SATs, Behavioral: Chronology of Perceived Discrimination Scale (CPDS), Behavioral: International Personality Item Pool (IPIP-NEO)This group (N=250) will be presented with the Maltreatment and Abuse Chronology of Exposure (MACE) scale toward the beginning of the session and the Math/Verbal Test toward the end. |
| Standardized Test Questions First Group | – | Behavioral: Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge, Behavioral: Standardized Maths and Verbal Questions such as the ones used in SATs, Behavioral: Chronology of Perceived Discrimination Scale (CPDS), Behavioral: International Personality Item Pool (IPIP-NEO)This group (N=250) will be presented with the standardized test questions (Math/Verbal) toward the beginning of the session and the Maltreatment and Abuse Chronology of Exposure (MACE) scale toward the end. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected online from participants across the USA. The study will include representative national sample (by age, sex, and ethnicity) of healthy volunteers, from the United States (total N=500) and will be conducted via Prolific™, which maintains a pool of research participants specifically interested in participating in online behavioral or psychological research studies.
Key inclusion criteria (1 listed)
- Healthy volunteers ages 18-65, living full-time in the U.S at the time of participation in the study.
Key exclusion criteria (1 listed)
- Below 18 or above 65. Living outside the U.S at the time of participation in the 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 |
|---|---|---|
| Maltreatment and Abuse Chronology of Exposure Scale as a stress challengeThe first group (N=250) will receive the Maltreatment and Abuse Chronology of Exposure (MACE) scale first, to assess early life adversity, followed by the standardized test questions. A POMS will be administered before each challenge. | Behavioural | MACE First Group, Standardized Test Questions First Group |
| Standardized Maths and Verbal Questions such as the ones used in SATsThe second group (N=250) will be presented with the standardized test questions (Math/Verbal) to assess their stress level, measured through POMS, followed by the Maltreatment and Abuse Chronology of Exposure (MACE) scale. | Behavioural | MACE First Group, Standardized Test Questions First Group |
| Chronology of Perceived Discrimination Scale (CPDS)The group will also receive the Chronology of Perceived Discrimination Scale (CPDS) to assess type and timing of perceived discrimination during the first 18 years of life. A POMS will be administered before and after the intervention/challenge. | Behavioural | MACE First Group, Standardized Test Questions First Group |
| International Personality Item Pool (IPIP-NEO)Participants in both groups will be presented with the abbreviated version of the IPIP-NEO a personality questionnaire that provides ratings on the Five Factor Personality Model. The research team sees this task as non-stressful and even potentially soothing and envisions that it will help to restore an individual's mood before taking the next stressful test and again at the completion of the online session. | Behavioural | MACE First Group, Standardized Test Questions First Group |
Primary outcome
Profile of Mood States (POMS)
Time frame: Through study completion, an average of 90 mins
The abbreviated form of the POMS(40-items) provides ratings of anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, friendliness and a total mood disturbance score. It takes only 3-5 minutes to complete. Items are scored as Not at all(0), A little(1), Moderately(2), Quite a lot(3), Extremely(4). Scores for the seven subscales in the abbreviated POMS are calculated by summing the numerical ratings for items that contribute to each subscale, with two items "Ashamed" and "Embarrassed" reverse scored.
Total Mood Disturbance (TMD)
Time frame: Through study completion, an average of 90 mins
Total Mood Disturbance (TMD) is calculated by summing the totals for the POMS negative subscales and then subtracting the totals for the POMS positive subscales. The formula is as follows: TMD = [Tension+Depression+Anger+Fatigue+Confusion] - [Vigor+Esteem-related Affect]
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 13 Mar 2024.
- Background: PubMed 18407006Anda RF, Brown DW, Dube SR, Bremner JD, Felitti VJ, Giles WH. Adverse childhood experiences and chronic obstructive pulmonary disease in adults. Am J Prev Med. 2008 May;34(5):396-403. doi: 10.1016/j.amepre.2008.02.002.
- Background: PubMed 12161676Anda RF, Whitfield CL, Felitti VJ, Chapman D, Edwards VJ, Dube SR, Williamson DF. Adverse childhood experiences, alcoholic parents, and later risk of alcoholism and depression. Psychiatr Serv. 2002 Aug;53(8):1001-9. doi: 10.1176/appi.ps.53.8.1001.
- Background: PubMed 20085623Brown DW, Anda RF, Felitti VJ, Edwards VJ, Malarcher AM, Croft JB, Giles WH. Adverse childhood experiences are associated with the risk of lung cancer: a prospective cohort study. BMC Public Health. 2010 Jan 19;10:20. doi: 10.1186/1471-2458-10-20.
- Background: PubMed 19840693Brown DW, Anda RF, Tiemeier H, Felitti VJ, Edwards VJ, Croft JB, Giles WH. Adverse childhood experiences and the risk of premature mortality. Am J Prev Med. 2009 Nov;37(5):389-96. doi: 10.1016/j.amepre.2009.06.021.
- Background: PubMed 12963569Dong M, Dube SR, Felitti VJ, Giles WH, Anda RF. Adverse childhood experiences and self-reported liver disease: new insights into the causal pathway. Arch Intern Med. 2003 Sep 8;163(16):1949-56. doi: 10.1001/archinte.163.16.1949.
- Background: PubMed 15381652Dong M, Giles WH, Felitti VJ, Dube SR, Williams JE, Chapman DP, Anda RF. Insights into causal pathways for ischemic heart disease: adverse childhood experiences study. Circulation. 2004 Sep 28;110(13):1761-6. doi: 10.1161/01.CIR.0000143074.54995.7F. Epub 2004 Sep 20.
- Background: PubMed 11754674Dube SR, Anda RF, Felitti VJ, Chapman DP, Williamson DF, Giles WH. Childhood abuse, household dysfunction, and the risk of attempted suicide throughout the life span: findings from the Adverse Childhood Experiences Study. JAMA. 2001 Dec 26;286(24):3089-96. doi: 10.1001/jama.286.24.3089.
- Background: PubMed 12612237Dube SR, Felitti VJ, Dong M, Chapman DP, Giles WH, Anda RF. Childhood abuse, neglect, and household dysfunction and the risk of illicit drug use: the adverse childhood experiences study. Pediatrics. 2003 Mar;111(3):564-72. doi: 10.1542/peds.111.3.564.
- Background: PubMed 12914833Dube SR, Felitti VJ, Dong M, Giles WH, Anda RF. The impact of adverse childhood experiences on health problems: evidence from four birth cohorts dating back to 1900. Prev Med. 2003 Sep;37(3):268-77. doi: 10.1016/s0091-7435(03)00123-3.
- Background: PubMed 9635069Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
- Background: PubMed 17945232Gordis EB, Granger DA, Susman EJ, Trickett PK. Salivary alpha amylase-cortisol asymmetry in maltreated youth. Horm Behav. 2008 Jan;53(1):96-103. doi: 10.1016/j.yhbeh.2007.09.002. Epub 2007 Sep 12.
- Background: PubMed 20124111Green JG, McLaughlin KA, Berglund PA, Gruber MJ, Sampson NA, Zaslavsky AM, Kessler RC. Childhood adversities and adult psychiatric disorders in the national comorbidity survey replication I: associations with first onset of DSM-IV disorders. Arch Gen Psychiatry. 2010 Feb;67(2):113-23. doi: 10.1001/archgenpsychiatry.2009.186.
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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.
Martin H Teicher, MD,PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological and Stress, Emotional, run by Mclean Hospital 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 1 inclusion and 1 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 13 Mar 2024. 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?
Profile of Mood States (POMS) (time frame: Through study completion, an average of 90 mins). The study lists 2 primary outcomes in all. 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 NCT06152549, which also lists 23 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 13 Mar 2024.