Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

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: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Healthy Mind Intervention (HMI); Behavioral: Healthy Body Intervention (HBI)

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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).	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.	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.	Difference between the interventions in the change of extinction learning from pre to post intervention.	0-9 weeks

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Alyson K Zalta, PhD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2015
• Primary Completion (Actual): November 14, 2018
• Study Completion (Actual): April 26, 2019

Study Registration Dates

• First Submitted: October 22, 2014
• First Submitted That Met QC Criteria: October 28, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 9, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Childhood trauma
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: K23MH103394 (U.S. NIH Grant/Contract)