Clinical trial NCT02808702: Brain Correlates of Self-Focused Processing
Official title: Brain Correlates of Self-Focused Processing as a Biomarker of Treatment Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Body Dysmorphic Disorder
Keywords: Attention
Cognitive behavioral therapy
Neuroimaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline clinical symptoms at 12 weeks
timeFrame: Baseline and 12 weeks from baseline
measure: Neural activation in the default mode network
timeFrame: Baseline and 12 weeks later
measure: Resting state functional connectivity within the default mode network
timeFrame: Baseline and 12 weeks later
measure: Response latencies during Self vs. Other conditions
timeFrame: Baseline and 12 weeks later
Secondary outcomes:
measure: Word valence during Self vs. Other conditions
timeFrame: Baseline and 12 weeks later
measure: Structural connectivity within the default mode network
timeFrame: Baseline and 12 weeks later
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Angela Fang, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fang A, Baran B, Beatty CC, Mosley J, Feusner JD, Phan KL, Wilhelm S, Manoach DS. Maladaptive self-focused attention and default mode network connectivity: a transdiagnostic investigation across social anxiety and body dysmorphic disorders. Soc Cogn Affect Neurosci. 2022 Jul 2;17(7):645-654. doi: 10.1093/scan/nsab130.