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Completed

NCT Number: NCT02279290

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Mind Intervention (HMI)

Behavioral

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.

Healthy Body Intervention (HBI)

Behavioral

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 31, 2014
Registry last updated
Jun 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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