An interventional study of Cognitive-behavioral therapy in Social Phobia and Body Dysmorphic Disorder, sponsored by Massachusetts General Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-31.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Twelve weekly sessions of individual cognitive-behavioral therapy
Behavioral: Cognitive-behavioral therapy
Twelve weekly sessions of individual cognitive-behavioral therapy
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and 12 weeks later
Word valence during Self vs. Other conditions
Number of positive and negative words endorsed during Self and Other task conditions
Time frame: Baseline and 12 weeks later
Structural connectivity within the default mode network
White matter connectivity within the default mode network during DTI scan
Time frame: Baseline and 12 weeks later
Plan to share: No
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Massachusetts General Hospital