NCT06152549

Brief 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. 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 Prolificâ„¢, 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2022

Completed
12 months until next milestone

First Posted

Study publicly available on registry

November 30, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

1.2 years

First QC Date

December 7, 2022

Last Update Submit

March 11, 2024

Conditions

Keywords

childhood maltreatment,adverse childhood experiencesstandardized math and verbal tests

Outcome Measures

Primary Outcomes (2)

  • 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.

    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 = \[Tension+Depression+Anger+Fatigue+Confusion\] - \[Vigor+Esteem-related Affect\]

    Through study completion, an average of 90 mins

Study Arms (2)

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.

Behavioral: Maltreatment and Abuse Chronology of Exposure Scale as a stress challengeBehavioral: Standardized Maths and Verbal Questions such as the ones used in SATsBehavioral: 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.

Behavioral: Maltreatment and Abuse Chronology of Exposure Scale as a stress challengeBehavioral: Standardized Maths and Verbal Questions such as the ones used in SATsBehavioral: Chronology of Perceived Discrimination Scale (CPDS)Behavioral: International Personality Item Pool (IPIP-NEO)

Interventions

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.

MACE First GroupStandardized Test Questions First Group

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.

MACE First GroupStandardized Test Questions First Group

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.

MACE First GroupStandardized Test Questions First Group

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.

MACE First GroupStandardized Test Questions First Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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 Prolificâ„¢, which maintains a pool of research participants specifically interested in participating in online behavioral or psychological research studies.

You may qualify if:

  • Healthy volunteers ages 18-65, living full-time in the U.S at the time of participation in the study.

You may not qualify if:

  • Below 18 or above 65. Living outside the U.S at the time of participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital through ProlificTM

Belmont, Massachusetts, 02478, United States

Location

Related Publications (23)

  • 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.

    PMID: 18407006BACKGROUND
  • Anda 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.

    PMID: 12161676BACKGROUND
  • Brown 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.

    PMID: 20085623BACKGROUND
  • Brown 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.

    PMID: 19840693BACKGROUND
  • Dong 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.

    PMID: 12963569BACKGROUND
  • Dong 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.

    PMID: 15381652BACKGROUND
  • Dube 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.

    PMID: 11754674BACKGROUND
  • Dube 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.

    PMID: 12612237BACKGROUND
  • Dube 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.

    PMID: 12914833BACKGROUND
  • Felitti 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.

    PMID: 9635069BACKGROUND
  • Gordis 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.

    PMID: 17945232BACKGROUND
  • Green 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.

    PMID: 20124111BACKGROUND
  • Heim 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.

    PMID: 18602762BACKGROUND
  • Kirschbaum 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.

    PMID: 8255414BACKGROUND
  • Monteleone 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.

    PMID: 29936175BACKGROUND
  • Navalta CP, Polcari A, Webster DM, Boghossian A, Teicher MH. Effects of childhood sexual abuse on neuropsychological and cognitive function in college women. J Neuropsychiatry Clin Neurosci. 2006 Winter;18(1):45-53. doi: 10.1176/jnp.18.1.45.

    PMID: 16525070BACKGROUND
  • Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schatzberg AF, Ninan PT, McCullough JP Jr, Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB. Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14293-6. doi: 10.1073/pnas.2336126100. Epub 2003 Nov 13.

    PMID: 14615578BACKGROUND
  • Obayashi K. Salivary mental stress proteins. Clin Chim Acta. 2013 Oct 21;425:196-201. doi: 10.1016/j.cca.2013.07.028. Epub 2013 Aug 9.

    PMID: 23939251BACKGROUND
  • Teicher MH, Samson JA. Childhood maltreatment and psychopathology: A case for ecophenotypic variants as clinically and neurobiologically distinct subtypes. Am J Psychiatry. 2013 Oct;170(10):1114-33. doi: 10.1176/appi.ajp.2013.12070957.

    PMID: 23982148BACKGROUND
  • Williams LM, Debattista C, Duchemin AM, Schatzberg AF, Nemeroff CB. Childhood trauma predicts antidepressant response in adults with major depression: data from the randomized international study to predict optimized treatment for depression. Transl Psychiatry. 2016 May 3;6(5):e799. doi: 10.1038/tp.2016.61.

    PMID: 27138798BACKGROUND
  • Grove, J.R., & Prapavessis, H. (1992). Preliminary evidence for the reliability and validity of an abbreviated Profile of Mood States. International Journal of Sport Psychology, 23, 93-109.

    RESULT
  • Norcross JC, Guadagnoli E, Prochaska JO. Factor structure of the Profile of Mood States (POMS): two partial replications. J Clin Psychol. 1984 Sep;40(5):1270-7. doi: 10.1002/1097-4679(198409)40:53.0.co;2-7.

  • Shichiri, K. , Shibuya, M. , Watanabe, M. , Tahashi, M. , Kaminushi, K. , Uenoyama, T. , Mashima, I. , Murayama, K. , Kuroda, T. and Suzuki, Y. (2016) Correlations between the Profile of Mood States (POMS) and the WHOQOL-26 among Japanese University Students. Health, 8, 416-420. doi: 10.4236/health.2016.85044.

    RESULT

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Martin H Teicher, MD,PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

December 7, 2022

First Posted

November 30, 2023

Study Start

October 15, 2022

Primary Completion

December 15, 2023

Study Completion

December 30, 2023

Last Updated

March 13, 2024

Record last verified: 2024-03

Locations