Transdiagnostic Brain-Behavior Profiling to Enhance Cognitive Behavioral Therapy Response
United States203 participantsStarted 2017-07-05
Plain-language summary
Many patients with Major Depressive Disorder (MDD) and generalized Social Anxiety Disorder (gSAD) are treated with cognitive behavioral therapy (CBT) but few have meaningful improvement. MDD and gSAD are diseases of brain dysfunction that manifest as impaired emotion regulation; CBT teaches emotion regulation strategies but how it works in the brain remains largely unknown. Individual differences in brain function related to emotion regulation may make some patients better suited for CBT and CBT may remedy the brain dysfunction that underlies these disorders. This project will compare CBT with a placebo psychotherapy (i.e., supportive therapy) in MDD and gSAD to test, validate, and refine brain-based markers and examine mechanisms of change to examine how CBT works and for whom.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. generally medically and neurologically healthy, including no evidence of mental retardation or serious cognitive impairment that would interfere with protocol adherence and/or task performance
. between the ages of 18 - 65 years old, inclusive
. right-handed
. primary diagnosis of MDD or gSAD based on the SCID DSM-5. Patients will be permitted to have limited comorbid and/or history of internalizing psychopathologies (e.g., generalized anxiety disorder, specific phobia, adjustment disorder)
Exclusion criteria
. personal current or past manic/hypomanic episode or psychotic symptoms
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study used brain scans to measure emotion regulation activity before and after CBT — can you tell me whether findings from this completed trial have been published, and what they suggested about who tends to respond best to CBT for depression or social anxiety?
2Since this trial looked at brain activity as a predictor of therapy outcome, is there any way in my own care to assess how likely I am to respond to CBT before committing to a 12-week course of it?
3The trial compared different treatment arms over 12 weeks — do you know what the different CBT approaches being compared were, and whether one showed stronger results for someone with my specific diagnosis?
4Given that this study enrolled people with either Major Depressive Disorder or Social Anxiety Disorder, and some people have both, how does my particular symptom profile affect which treatment path you'd recommend for me right now?
5Since this trial is now completed and I can't enroll, are there any similar studies currently recruiting that use brain-based tools to personalize psychotherapy, or would standard CBT be the most practical next step for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in Symptom Severity From Baseline to Week 12 Between Treatment Arms
Timeframe: baseline and week 12
2
Baseline Brain Activity During Emotion Regulation Differences Between Controls and Patients
Timeframe: baseline
3
Comparisons Between Emotion Regulation Task Brain Activity at Baseline and After Completing Therapy (12 Weeks).
Timeframe: baseline and 12 weeks
4
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.
Timeframe: baseline
5
Baseline Brain Activity During Emotion Regulation as a Predictor of Psychotherapy Outcome Collapsed Across Treatment Arm.