Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

Not Applicable

Completed

• Conditions: Depression; Anxiety
• Interventions: Behavioral: Healthy Body Intervention (HBI); Behavioral: Healthy Mind Intervention (HMI)

• Registration Number: NCT02279290
• Lead Sponsor: Rush University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-22
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-31
• Study Start: 2015-07-13
• Primary Completion: 2018-11-14
• Study Completion: 2019-04-26
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy Body Intervention (HBI)	Healthy Body Intervention (HBI)	This intervention will focus on important health-related topics.
Healthy Mind Intervention (HMI)	Healthy Mind Intervention (HMI)	This intervention will focus on teaching individuals a way to manage acute and chronic stressors more effectively.

Primary Outcome Measures

Name	Time	Method
Extinction learning will be analyzed using the fear potentiated startle data from a fear conditioning paradigm.	0-9 weeks	Difference between the interventions in the change of extinction learning from pre to post intervention.
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).	0 - 9 weeks	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.	0-9 weeks	Difference between the interventions in the change of biological resilience from pre to post intervention.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States