Brain Correlates of Self-Focused Processing

Study Overview
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Brief Summary
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The purpose of this study is to determine whether neuroimaging-based markers of maladaptive self-focused processing are better predictors of treatment response to cognitive-behavioral therapy than behavioral markers.

Detailed Description
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First, the investigators propose to identify the neural correlates of self-focused processing. The investigators will assess baseline resting state connectivity within the default network, as well as regional brain activation using a well-validated event-related fMRI task that manipulates self-focused processing in patients with body dysmorphic and socially anxious symptoms, compared to healthy controls. This clinical sample was selected because such patients display heightened self-focused attention, and sampling individuals across these symptom dimensions will ensure greater variability on this dimension of maladaptive self-focused processing. Second, the investigators will examine the neural correlates of self-focused processing as a predictor of treatment response. Neuroimaging data will be acquired from patients with body dysmorphic and socially anxious symptoms during two scan sessions, before and after 12 weeks of individual cognitive behavioral therapy, and compared with healthy controls scanned twice at a 12 week interval. Finally, the investigators will compare the prediction of treatment response between neural measures and behavioral measures of self-focused processing. The investigators will assess the behavioral correlates of self-focused processing using a self-reference effect paradigm, and assess their relation to treatment response. If the investigators hypotheses are borne out, the investigators will have new targets for treatment, a method to identify promising candidates for treatment, and sensitive surrogate markers of treatment response.

Official Title
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Brain Correlates of Self-Focused Processing as a Biomarker of Treatment Response

Conditions
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Social Phobia, Body Dysmorphic Disorder

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, age 18-45 For patients: treatment-seeking individuals presenting with at least moderate levels of social anxiety/body dysmorphic symptoms, and a score of at least 1 SD above the mean on the public self-consciousness scale of the Self-Consciousness Scale- Revised For healthy controls only: no current or lifetime history of psychiatric disorders, and score of below 1 SD of mean on the SCS-R Right-handed, as determined by the Handedness Inventory Fluent in English, and willing to provide informed consent Exclusion Criteria: Positive MR screen History of head injury, neurological disorder, or neurosurgical procedure Active suicidal or homicidal ideation Current or past manic/hypomanic episode or psychotic symptoms Active alcohol and substance dependence (as assessed by the SCID-5-RV Current use of psychotropic medications, except antidepressants taken at a stable dose for 2 weeks, to maximize generalizability of sample Current CBT and/or formal mindfulness/meditation training History of more than 10 sessions of CBT and formal mindfulness/meditation training

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioral therapy<br>Twelve weekly sessions of individual cognitive-behavioral therapy | Behavioral: Cognitive-behavioral therapy<br>* Twelve weekly sessions of individual cognitive-behavioral therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline clinical symptoms at 12 weeks | Evidence of symptom improvement as determined by clinician-administered assessment of body dysmorphic and socially anxious symptoms | Baseline and 12 weeks from baseline | 
| Neural activation in the default mode network | Difference in regional brain activation in the default mode network in the Self vs. Other contrast (specifically in the medial prefrontal cortex, temporoparietal junction, posterior cingulate) during fMRI activation paradigm | Baseline and 12 weeks later | 
| Resting state functional connectivity within the default mode network | Functional connectivity within the default mode network during resting state scan | Baseline and 12 weeks later | 
| Response latencies during Self vs. Other conditions | Difference in average response latencies (in ms) during Self and Other conditions of a self-referential processing task | Baseline and 12 weeks later | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word valence during Self vs. Other conditions | Number of positive and negative words endorsed during Self and Other task conditions | Baseline and 12 weeks later | 
| Structural connectivity within the default mode network | White matter connectivity within the default mode network during DTI scan | Baseline and 12 weeks later | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Attention, Cognitive behavioral therapy, Neuroimaging