Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

June 9, 2021 updated by: Alyson Zalta, Rush University Medical Center
This randomized controlled trial uses a modularized cognitive behavioral resilience training (MCBRT) intervention to probe risk and resilience mechanisms linked to post-trauma psychopathology. Ninety participants with a history of interpersonal trauma during childhood or adolescence and mild to moderate distress will be randomized to MCBRT or a health education control condition. The primary aims of this proposal are to examine whether individuals who receive MCBRT demonstrate increases in psychological resilience, biological resilience, and extinction learning compared to those in the control group. This study will also explore associations between these psychobiobehavioral risk and resilience factors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. fluent in English
  3. history of childhood interpersonal trauma (e.g., sexual assault, physical assault, witnessing assault before age 18)
  4. mild to moderate distress indicated by a score of 10-20 on the depression scale, 8-14 on the anxiety scale, or 15-25 on the stress scale of the DASS-21.

Exclusion Criteria:

  1. severe distress indicated by a score >20 on the depression scale, >14 on the anxiety scale, or >25 on the stress scale of the DASS-21
  2. DSM-5 criterion A trauma in the past month
  3. color blindness based on self-report (because of inability to complete the fear conditioning task)
  4. auditory impairment based on audiometer screening (because of inability to complete the fear conditioning task)
  5. lifetime psychotic or bipolar disorder
  6. substance abuse or dependence within past 6 months
  7. concurrent psychotherapy initiated within 3 months of randomization
  8. ongoing psychotherapy of any duration directed toward treatment of trauma-related psychopathology (e.g., CBT)
  9. must be on a stable dose of psychotropic or adrenergically-active medications (e.g., beta blockers) for at least 6 weeks prior to eligibility screening
  10. mental retardation or significant cognitive impairment
  11. serious medical illness or instability for which hospitalization may be likely within the next year
  12. significant suicidal ideation indicated by "yes" on Columbia Suicide Severity Rating Scale item 4 (active suicidal ideation with some intent to act) or enacted suicidal behaviors within 6 months prior to eligibility
  13. current legal actions related to trauma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Healthy Mind Intervention (HMI)
This intervention will focus on teaching individuals a way to manage acute and chronic stressors more effectively.
Behavioral: Healthy Mind Intervention (HMI)
Healthy Mind Intervention (HMI) is a flexible cognitive-behavioral resilience building program. Participants will receive 8 weekly, 60-minute individual sessions of HMI. In HMI, participants will be able to select 3 areas of resilience that they want to work on.
Active Comparator: Healthy Body Intervention (HBI)
This intervention will focus on important health-related topics.
Behavioral: Healthy Body Intervention (HBI)
The 8 weekly, 60-minute individual sessions will include the following topics: the mind-body connection, nutrition, exercise, unhealthy substances, sleep, preventing illness, and preventive care. Each session is spent providing didactic information on these topics and strategies for how to engage in behavior change in these areas.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychological resilience outcomes include emotion regulation (DERS), hardiness (CD-RISC), optimism (LOT-R), perceived control (SMS), social support (MSPSS), and task-oriented coping (CISS-SFT).
Time Frame: 0 - 9 weeks
Difference between the interventions in the change of psychological resilience from pre to post intervention.
0 - 9 weeks
Biological resilience outcomes include neuropeptide Y [NPY], dehydroepiandrosterone [DHEA], allopregnanolone [ALLO] taken from a blood draw.
Time Frame: 0-9 weeks
Difference between the interventions in the change of biological resilience from pre to post intervention.
0-9 weeks
Extinction learning will be analyzed using the fear potentiated startle data from a fear conditioning paradigm.
Time Frame: 0-9 weeks
Difference between the interventions in the change of extinction learning from pre to post intervention.
0-9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rush University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alyson K Zalta, PhD, Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 13, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 14, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K23MH103394 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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