Brain Correlates of Self-Focused Processing

Social Phobia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808702
• Other study ID #: 1K23MH109593-01
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: March 13, 2020

Study information

• Verified date: October 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 13, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders
• Phobia, Social
• Social Phobia

Intervention

Behavioral:
• Cognitive-behavioral therapy
Twelve weekly sessions of individual cognitive-behavioral therapy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Structural connectivity within the default mode network	White matter connectivity within the default mode network during DTI scan	Baseline and 12 weeks later