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Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02279290
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Alyson Zalta, University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Healthy Mind Intervention (HMI) Behavioral: Healthy Body Intervention (HBI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology
Actual Study Start Date : July 13, 2015
Actual Primary Completion Date : November 14, 2018
Actual Study Completion Date : April 26, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279290


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Alyson K Zalta, PhD Rush University Medical Center
  Study Documents (Full-Text)

Documents provided by Alyson Zalta, University of California, Irvine:
Informed Consent Form  [PDF] June 20, 2018


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Responsible Party: Alyson Zalta, Assistant Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02279290    
Other Study ID Numbers: K23MH103394 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Keywords provided by Alyson Zalta, University of California, Irvine:
Childhood trauma
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms