MACEStress: Online Emotional Response to Completing a Childhood Maltreatment Self-report Scale

Sponsor
Mclean Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06152549
Collaborator
(none)
500
1
14.5
34.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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)

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

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
Assessing the Emotional and Physiological Response of Adults to Completing a Self-report Scale on Exposure to Childhood Maltreatment - Online Component
Actual Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Dec 15, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
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 challenge
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.

Behavioral: Standardized Maths and Verbal Questions such as the ones used in SATs
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.

Behavioral: 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.

Behavioral: 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. We see this task as non-stressful and even potentially soothing and envision that it will help to restore and individual's mood before taking the next stressful test and again at the completion of the online session.

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 challenge
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.

Behavioral: Standardized Maths and Verbal Questions such as the ones used in SATs
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.

Behavioral: 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.

Behavioral: 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. We see this task as non-stressful and even potentially soothing and envision that it will help to restore and individual's mood before taking the next stressful test and again at the completion of the online session.

Outcome Measures

Primary Outcome Measures

  1. Profile of Mood States (POMS) [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.

  2. Total Mood Disturbance (TMD) [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy volunteers ages 18-65, living full-time in the U.S at the time of participation in the study.
Exclusion Criteria:
  • Below 18 or above 65. Living outside the U.S at the time of participation in the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 McLean Hospital through ProlificTM Belmont Massachusetts United States 02478

Sponsors and Collaborators

  • Mclean Hospital

Investigators

  • Principal Investigator: Martin H Teicher, MD,PhD, Mclean Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Martin H Teicher, Associate Professor of Psychiatry, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT06152549
Other Study ID Numbers:
  • 401730
First Posted:
Nov 30, 2023
Last Update Posted:
Nov 30, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Martin H Teicher, Associate Professor of Psychiatry, Mclean Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 30, 2023