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Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

Primary Purpose

Anxiety, Depression

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Healthy Mind Intervention (HMI)

Healthy Body Intervention (HBI)

About this trial

This is an interventional prevention trial for Anxiety focused on measuring Childhood trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years of age or older
fluent in English
history of childhood interpersonal trauma (e.g., sexual assault, physical assault, witnessing assault before age 18)
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:

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
DSM-5 criterion A trauma in the past month
color blindness based on self-report (because of inability to complete the fear conditioning task)
auditory impairment based on audiometer screening (because of inability to complete the fear conditioning task)
lifetime psychotic or bipolar disorder
substance abuse or dependence within past 6 months
concurrent psychotherapy initiated within 3 months of randomization
ongoing psychotherapy of any duration directed toward treatment of trauma-related psychopathology (e.g., CBT)
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
mental retardation or significant cognitive impairment
serious medical illness or instability for which hospitalization may be likely within the next year
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
current legal actions related to trauma.

Sites / Locations

Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Healthy Mind Intervention (HMI)

Healthy Body Intervention (HBI)

Arm Description

This intervention will focus on teaching individuals a way to manage acute and chronic stressors more effectively.

This intervention will focus on important health-related topics.

Outcomes

Primary Outcome Measures

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).

Difference between the interventions in the change of psychological resilience from pre to post intervention.

Biological resilience outcomes include neuropeptide Y [NPY], dehydroepiandrosterone [DHEA], allopregnanolone [ALLO] taken from a blood draw.

Difference between the interventions in the change of biological resilience from pre to post intervention.

Extinction learning will be analyzed using the fear potentiated startle data from a fear conditioning paradigm.

Difference between the interventions in the change of extinction learning from pre to post intervention.

Secondary Outcome Measures

Full Information

NCT ID

NCT02279290

First Posted

October 22, 2014

Last Updated

June 9, 2021

Sponsor

Rush University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02279290

Brief Title

Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

Official Title

Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

July 13, 2015 (Actual)

Primary Completion Date

November 14, 2018 (Actual)

Study Completion Date

April 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rush University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression

Keywords

Childhood trauma

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Mind Intervention (HMI)

Arm Type

Experimental

Arm Description

This intervention will focus on teaching individuals a way to manage acute and chronic stressors more effectively.

Arm Title

Healthy Body Intervention (HBI)

Arm Type

Active Comparator

Arm Description

This intervention will focus on important health-related topics.

Intervention Type

Behavioral

Intervention Name(s)

Healthy Mind Intervention (HMI)

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Healthy Body Intervention (HBI)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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).

Description

Difference between the interventions in the change of psychological resilience from pre to post intervention.

Time Frame

0 - 9 weeks

Title

Biological resilience outcomes include neuropeptide Y [NPY], dehydroepiandrosterone [DHEA], allopregnanolone [ALLO] taken from a blood draw.

Description

Difference between the interventions in the change of biological resilience from pre to post intervention.

Time Frame

0-9 weeks

Title

Extinction learning will be analyzed using the fear potentiated startle data from a fear conditioning paradigm.

Description

Difference between the interventions in the change of extinction learning from pre to post intervention.

Time Frame

0-9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older fluent in English history of childhood interpersonal trauma (e.g., sexual assault, physical assault, witnessing assault before age 18) 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: 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 DSM-5 criterion A trauma in the past month color blindness based on self-report (because of inability to complete the fear conditioning task) auditory impairment based on audiometer screening (because of inability to complete the fear conditioning task) lifetime psychotic or bipolar disorder substance abuse or dependence within past 6 months concurrent psychotherapy initiated within 3 months of randomization ongoing psychotherapy of any duration directed toward treatment of trauma-related psychopathology (e.g., CBT) 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 mental retardation or significant cognitive impairment serious medical illness or instability for which hospitalization may be likely within the next year 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 current legal actions related to trauma.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alyson K Zalta, PhD

Organizational Affiliation

Rush University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

12. IPD Sharing Statement

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Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

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