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Approach-Avoidance, Computational Framework for Predicting Behavioral Therapy Outcome (AAC-BeT) (AAC-BeT)

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ClinicalTrials.gov Identifier: NCT04426461
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : October 28, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Laureate Institute for Brain Research, Inc.

Brief Summary:

Depression and anxiety disorders rank in the top ten causes of years lived with disability. Less than 50% of patients experiencing long-lasting improvements to current gold-standard treatments. Two gold-standard behavioral interventions include behavioral activation, focused on enhancing approach behavior towards meaningful activities, and exposure-based therapy, focused on decreasing avoidance and challenging negative expectations. While these interventions have divergent treatment targets, there is little knowledge to inform which strategies should be used in the frequent case of comorbid anxiety and depression. Approach-avoidance decision-making paradigms focus on assessing responses when faced with potential rewards and threats, tapping into processes important for both anxiety and depression as well as behavioral activation and exposure-based therapy.

For this study, investigators will recruit individuals reporting both anxiety and depression symptoms and randomize them to one of three different interventions: (1) behavioral activation, (2) exposure-based therapy, and a non-specific therapy approach (3) supportive therapy. Participants will complete clinical, self-report, behavioral, and functional magnetic resonance imaging (fMRI) assessments before and after therapy. Investigators will use a computational approach to model factors that may influence one's behavior during approach-avoidance decision-making, including drives to avoid threat versus approach reward and confidence versus uncertainty in one's decisions.

This project will accomplish the following aims (1) Determine how changes in brain and behavior responses during approach-avoidance conflict relate to changes in mental health symptoms with the different therapy approaches, (2) Determine the degree to which baseline brain and behavior responses during approach-avoidance conflict predict response to the different therapy approaches, above and beyond the influence of demographics and baseline symptom severity.

Results will enhance understanding of how different psychotherapy approaches (behavioral activation, exposure-based therapy) may impact brain responses and decisions when faces with potential reward versus threat and approach versus avoidance drives. In addition, results will have important implications concerning the potential for a more personalized approach to psychotherapy, enhancing knowledge of which types of therapy strategies may be most beneficial for which individuals.


Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Behavioral Activation Behavioral: Exposure-based therapy Behavioral: Supportive therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to behavioral activation, exposure-based, or supportive therapy according to parallel assignment, stratified by sex (male, female) and symptom severity (mild, moderate, severe).
Masking: Single (Outcomes Assessor)
Masking Description: Interview-based assessments will be conducted by blinded clinical assessors and participants will be blinded until after completion of all baseline assessments.
Primary Purpose: Basic Science
Official Title: An Approach-Avoidance, Computational Framework for Predicting Behavioral Therapy Outcome in Anxiety and Depression (AAC-BeT)
Actual Study Start Date : September 11, 2020
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Behavioral activation Behavioral: Behavioral Activation
Behavioral activation will be delivered as a 10-week, manualized, behavioral intervention focused on enhancing engagement in meaningful and reinforcing activities.

Experimental: Exposure-based therapy Behavioral: Exposure-based therapy
Exposure-based therapy will be delivered as a 10-week, manualized, behavioral intervention focused on decreasing avoidance to allow for inhibitory learning and challenging negative expectations.

Active Comparator: Supportive therapy Behavioral: Supportive therapy
Supportive therapy will be delivered as a 10-week, manualized intervention focused on encouraging patients to talk openly about their thoughts, emotions, and any past or current concerns.




Primary Outcome Measures :
  1. Composite score from Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: Up to 18 weeks after the baseline assessments ]
    Composite score (averaging of the standardized Z scores) from the Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D). These Z scores will range from -3.0 to +3.0, with greater scores indicating more severe anxiety and depression symptoms or worse outcome.


Secondary Outcome Measures :
  1. Sheehan Disability Scale [ Time Frame: Up to 18 weeks after the baseline assessments ]
    Sheehan Disability Scale total score. This score ranges from 0-30, with higher scores indicating greater disability or worse outcome.

  2. National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Anxiety Scale [ Time Frame: Up to 18 weeks after the baseline assessments ]
    National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Anxiety Scale, which is reported as a T score. The T scores can range from - to 100, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater symptom severity or worse outcome.

  3. National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Depression Scale [ Time Frame: Up to 18 weeks after the baseline assessments ]
    National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Depression Scale, which is reported as a T score. The T scores can range from - to 100, with a mean of 50 and a standard deviation of 10. Higher scores indicate greater symptom severity or worse outcome.


Other Outcome Measures:
  1. Amygdala reactivity to negative outcomes [ Time Frame: Up to 14 weeks after the baseline assessments. ]
    Beta coefficient from general linear model for right amygdala region of interest in response to negative image outcome phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater amygdala reactivity or worse outcomes.

  2. Dorsolateral prefrontal cortex reactivity to conflict decisions [ Time Frame: Up to 14 weeks after the baseline assessments. ]
    Beta coefficient from general linear model for right dorsolateral prefrontal region of interest in response to the conflict decision phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater dorsolateral prefrontal cortex reactivity.

  3. Dorsal striatal reactivity to negative outcomes [ Time Frame: Up to 14 weeks after the baseline assessments. ]
    Beta coefficient from general linear model for dorsal striatal region of interest in response to negative image outcome phase of an approach-avoidance conflict decision-making task. Standardized beta coefficients have a range of 0 to 1, with greater values indicating greater striatal reactivity.

  4. Decision uncertainty during approach-avoidance conflict decision making [ Time Frame: Up to 14 weeks after the baseline assessments. ]
    Decision uncertainty parameter from computational modeling of behavioral responses on the approach avoidance conflict task. Parameter values have a range of 0 to 20, with greater values indicating greater decision uncertainty.

  5. Emotional conflict during approach-avoidance conflict decision making [ Time Frame: Up to 14 weeks after the baseline assessments. ]
    Emotional conflict parameter from computational modeling of behavioral responses on the approach avoidance conflict task. Parameter values have a range of 0 to 7, with greater values indicating greater conflict.

  6. Approach behavior during approach-avoidance conflict decision making [ Time Frame: Up to 14 weeks after the baseline assessments. ]
    Average approach behavior on conflict trials of an approach avoidance conflict task. Average approach behavior values have a range of 0 to 10, with greater values indicating greater approach behavior.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • score >55 on both the PROMIS Anxiety and PROMIS Depression scales
  • score >5 on any one item of the SDS
  • able to provide informed consent
  • report of anxiety and depressive symptoms as areas of clinical concern
  • sufficient English proficiency to complete procedures.

Exclusion Criteria:

  • significant or unstable physical or mental health conditions (e.g., immediate suicidal intent) requiring medical attention
  • history of bipolar, psychotic, cognitive, obsessive compulsive disorder, posttraumatic stress disorder (PTSD)
  • history of moderate to severe substance use disorder over the past year
  • diagnosis of neurologic disorders
  • MRI contra-indications (e.g., metal in body)
  • uncorrected vision/hearing problems
  • current, regular benzodiazepine use

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04426461


Contacts
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Contact: Mallory Cannon, M.S. 918-581-4885 neurocatt@laureateinstitute.org
Contact: Robin L Aupperle, PhD 918-502-5744 raupperle@laureateinstitute.org

Locations
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United States, Oklahoma
Laureate Institute for Brain Research Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Mallory Cannon, BA    918-581-4885    neurocatt@laureateinstitute.org   
Contact: Robin Aupperle, PhD    918-502-5744    raupperle@laureateinstitute.org   
Principal Investigator: Robin L Aupperle, PhD         
Sponsors and Collaborators
Laureate Institute for Brain Research, Inc.
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Robin L Aupperle, PhD Laureate Institute for Brain Research
Publications:
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Responsible Party: Laureate Institute for Brain Research, Inc.
ClinicalTrials.gov Identifier: NCT04426461    
Other Study ID Numbers: 2020-003
R01MH123691 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After publication of results from the primary aims of this project, we intend to make the data used in publications (e.g., self-report, behavior, and neuroimaging data) accessible in a public database. These data will be stripped of patient identifiers and will comply with HIPAA requirements for publicly accessible datasets. User registration will be required to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Immediately after publication of results from the primary aims of this project.
Access Criteria: User registration will be required to access or download files. As part of the registration process, users must agree to the conditions of use governing access to the public release data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgement of the data resource.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms