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

Not Applicable

Recruiting

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Exposure-based therapy; Behavioral: Supportive therapy; Behavioral: Behavioral Activation

• Registration Number: NCT04426461
• Lead Sponsor: 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. In addition, by including peripheral blood draws and measures of grace matter volume, the project will also accomplish the following aims: (1) Determine whether kynrenine metabolites measures peripherally may be beneficial as a biomarker of treatment response and (2) determine whether there is an association between change in kynurenine metabolites and changes in gray matter volume with treatment.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Study Start: 2020-09-11
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exposure-based therapy	Exposure-based therapy	-
Supportive therapy	Supportive therapy	-
Behavioral activation	Behavioral Activation	-

Primary Outcome Measures

Name	Time	Method
Composite score from Hamilton Anxiety Rating Scale (HAM-A) and Hamilton Rating Scale for Depression (HAM-D)	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.
Quinolinic Acid	Up to 18 weeks after the baseline assessments	Peripheral serum concentration of Quinolinic Acid

Secondary Outcome Measures

Name	Time	Method
Ratio of kynurenic acid to quinolinic acid	Up to 14 weeks after the baseline assessments	Ratio of peripheral serum concentration of kynurenic acid to quinolinic acid
Kynurenic acid	Up to 14 weeks after the baseline assessments	Peripheral serum concentration of kynurenic acid
Ratio of kynurenic acid to tryptophan	Up to 18 weeks after the baseline assessments	Ratio of peripheral serum concentration of kynurenic acid to tryptophan
National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Depression Scale	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.
Sheehan Disability Scale	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.
National Institute of Health (NIH) Patient Reported Outcome Measurement and Information System (PROMIS) Anxiety Scale	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.

Trial Locations

Locations (1)

Laureate Institute for Brain Research; 🇺🇸 Tulsa, Oklahoma, United States