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Brain Correlates of Self-Focused Processing

Primary Purpose

Social Phobia, Body Dysmorphic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Phobia focused on measuring Attention, Cognitive behavioral therapy, Neuroimaging

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive-behavioral therapy

Arm Description

Twelve weekly sessions of individual cognitive-behavioral therapy

Outcomes

Primary Outcome Measures

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
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
Resting state functional connectivity within the default mode network
Functional connectivity within the default mode network during resting state scan
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

Secondary Outcome Measures

Word valence during Self vs. Other conditions
Number of positive and negative words endorsed during Self and Other task conditions
Structural connectivity within the default mode network
White matter connectivity within the default mode network during DTI scan

Full Information

First Posted
June 8, 2016
Last Updated
October 28, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02808702
Brief Title
Brain Correlates of Self-Focused Processing
Official Title
Brain Correlates of Self-Focused Processing as a Biomarker of Treatment Response
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
March 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Phobia, Body Dysmorphic Disorder
Keywords
Attention, Cognitive behavioral therapy, Neuroimaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-behavioral therapy
Arm Type
Experimental
Arm Description
Twelve weekly sessions of individual cognitive-behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
Twelve weekly sessions of individual cognitive-behavioral therapy
Primary Outcome Measure Information:
Title
Change from baseline clinical symptoms at 12 weeks
Description
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
Title
Neural activation in the default mode network
Description
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
Title
Resting state functional connectivity within the default mode network
Description
Functional connectivity within the default mode network during resting state scan
Time Frame
Baseline and 12 weeks later
Title
Response latencies during Self vs. Other conditions
Description
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
Secondary Outcome Measure Information:
Title
Word valence during Self vs. Other conditions
Description
Number of positive and negative words endorsed during Self and Other task conditions
Time Frame
Baseline and 12 weeks later
Title
Structural connectivity within the default mode network
Description
White matter connectivity within the default mode network during DTI scan
Time Frame
Baseline and 12 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Fang, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34875086
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.
Results Reference
derived

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Brain Correlates of Self-Focused Processing

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