Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology

NCT ID: NCT02279290

Last Updated: 2021-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-13
• Study Completion Date: 2019-04-26

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.

Conditions

Anxiety; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Mind Intervention (HMI)

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

Group Type: EXPERIMENTAL

Healthy Mind Intervention (HMI)

Intervention Type: 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)

This intervention will focus on important health-related topics.

Group Type: ACTIVE_COMPARATOR

Healthy Body Intervention (HBI)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Alyson Zalta

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alyson K Zalta, PhD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

K23MH103394

Identifier Type: NIH

Identifier Source: org_study_id

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