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)
Sponsored by

About this trial
This is an interventional prevention trial for Anxiety focused on measuring Childhood trauma
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.
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
No
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
No
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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