AnxietyNCT02279290
Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology
A study testing Healthy Mind Intervention (HMI) and Healthy Body Intervention (HBI) in people with Anxiety and Depression, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- Healthy Mind Intervention (HMI) and Healthy Body Intervention (HBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2015to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
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
- Being tested
- Healthy Mind Intervention (HMI), Healthy Body Intervention (HBI)
- Keywords
- Childhood trauma
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Mind Intervention (HMI)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Mind Intervention (HMI) | Experimental | This intervention will focus on teaching individuals a way to manage acute and chronic stressors more effectively. Receives: Behavioral: Healthy Mind Intervention (HMI) |
| Healthy Body Intervention (HBI) | Active comparator | This intervention will focus on important health-related topics. Receives: Behavioral: Healthy Body Intervention (HBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 0-9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study start13 Jul 2015
- Primary completion14 Nov 2018
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyson Zalta, University of California, Irvine
- Investigators
- Alyson K Zalta, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279290
- Sponsor's protocol ID
- K23MH103394
- Status last verified
- Jun 2021
- First submitted
- 22 Oct 2014
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using CBT to Probe Psychobiobehavioral Resilience to Post-trauma Psychopathology
- ClinicalTrials.gov ID
- NCT02279290
- Acronym / sponsor ID
- K23MH103394
- Conditions
- Anxiety, Depression
- Keywords
- Childhood trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 13 Jul 2015 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Mind Intervention (HMI) | Experimental | Behavioral: Healthy Mind Intervention (HMI)This intervention will focus on teaching individuals a way to manage acute and chronic stressors more effectively. |
| Healthy Body Intervention (HBI) | Active comparator | Behavioral: Healthy Body Intervention (HBI)This intervention will focus on important health-related topics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Healthy Mind Intervention (HMI) |
| 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. | Behavioural | Healthy Body Intervention (HBI) |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyson K Zalta, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Mind Intervention (HMI) and Healthy Body Intervention (HBI) in people with Anxiety and Depression, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.