Brain Correlates of Self-Focused Processing

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

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.

Study Overview

• Status: Completed
• Conditions: Social Phobia; Body Dysmorphic Disorder
• Intervention / Treatment: Behavioral: Cognitive-behavioral therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-behavioral therapy; Twelve weekly sessions of individual cognitive-behavioral therapy	Behavioral: Cognitive-behavioral therapy; Twelve weekly sessions of individual cognitive-behavioral therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Angela Fang, Ph.D., University of Washington

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): March 13, 2020
• Study Completion (Actual): March 13, 2020

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Attention; Neuroimaging
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Somatoform Disorders; Phobia, Social; Body Dysmorphic Disorders
• Other Study ID Numbers: 1K23MH109593-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No