No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 24
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
110 (estimated)
Sponsor
University of Michigan · Other
Who this trial is looking for
This trial is looking for young adults with anxiety disorders to understand how brain activity affects emotion regulation. Participants will use a tool that helps control brain activity while receiving feedback during training sessions.
Are You a Good Fit for This Trial?
Rules you outObsessive Compulsive DisorderPosttraumatic Stress DisorderBipolar DisorderSubstance AbuseActive SuicidalityPsychosis
You may be able to join if
I have been diagnosed with generalized anxiety disorder or a related condition.
I score 2 or more on at least one anxiety question.
I am medically and physically able to give consent.
I am not regularly taking any medications with psychotropic effects, except certain ones.
I have been on the same hormonal contraceptive for at least 3 months.
I can tolerate small, enclosed spaces without anxiety.
I have no metals or implants in my body that could cause problems in a magnetic field.
I fit in the scanner size requirements.
You may not be able to join if
I have current obsessive-compulsive disorder or PTSD.
I have current substance abuse or dependence.
I am actively suicidal with a plan or intent.
I have current psychosis.
I have a serious neurological illness or condition that affects brain function.
I have had a closed head injury with loss of consciousness for more than 5 minutes.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand th…
This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback.
The study hypotheses include:
* Participants receiving veritable-Neurofeedback (NF) will show a greater activation increases in the prefrontal cortex (PFC) compared to sham-NF
* Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF
* PFC activation will positively correlate with CR ability
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Primary diagnosis (primary source of distress and/or interference) of generalized anxiety disorder, social anxiety disorder, panic disorder or illness anxiety disorder based on structured interview. Comorbid phobic disorders allowed, but these cannot be the primary source of i…
Inclusion Criteria:
* Primary diagnosis (primary source of distress and/or interference) of generalized anxiety disorder, social anxiety disorder, panic disorder or illness anxiety disorder based on structured interview. Comorbid phobic disorders allowed, but these cannot be the primary source of interference or distress due to the lowered chances of encountering anxiety-provoking stimuli during the study period
* Score of 2 or more on at least 1 question from GAD/CROSS-AD composite
* Medically and physically able to consent
* Not regularly taking any medication, prescription or non-prescription, with psychotropic effects other than:
1. Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
2. The same oral hormonal contraceptive for at least 3 months
* For females, not currently pregnant or actively trying to become pregnant
* Ability to tolerate small, enclosed spaces without anxiety
* No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (per protocol)
* Size compatible with scanner gantry (per protocol)
Exclusion Criteria:
* Current diagnosis of Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, or Bipolar Disorder
* Current substance abuse or dependence (past 6 months)
* Active suicidality with plan or intent
* Current psychosis
* History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
* History of closed head injury, e.g., loss of consciousness greater (\>) approximately (\~) 5 minutes, hospitalization, neurological sequela
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