Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

Rush

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: Healthy Body Intervention (HBI); Behavioral: Healthy Mind Intervention (HMI)

Study type: Interventional

Funder types: Other

Identifiers

NCT02279290

K23MH103394

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Healthy Mind Intervention (HMI)

Experimental group

Description:

This intervention will focus on teaching individuals a way to manage acute and chronic stressors more effectively.

Treatment:

Behavioral: Healthy Mind Intervention (HMI)

Healthy Body Intervention (HBI)

Active Comparator group

Description:

This intervention will focus on important health-related topics.

Treatment:

Behavioral: Healthy Body Intervention (HBI)