Brain Correlates of Self-Focused Processing

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02808702
Collaborator
(none)
60
2
1
64
30
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive-behavioral therapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Brain Correlates of Self-Focused Processing as a Biomarker of Treatment Response
Actual Study Start Date :
May 1, 2017
Actual Primary Completion Date :
Mar 13, 2020
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline clinical symptoms at 12 weeks [Baseline and 12 weeks from baseline]

    Evidence of symptom improvement as determined by clinician-administered assessment of body dysmorphic and socially anxious symptoms

  2. Neural activation in the default mode network [Baseline and 12 weeks later]

    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

  3. Resting state functional connectivity within the default mode network [Baseline and 12 weeks later]

    Functional connectivity within the default mode network during resting state scan

  4. Response latencies during Self vs. Other conditions [Baseline and 12 weeks later]

    Difference in average response latencies (in ms) during Self and Other conditions of a self-referential processing task

Secondary Outcome Measures

  1. Word valence during Self vs. Other conditions [Baseline and 12 weeks later]

    Number of positive and negative words endorsed during Self and Other task conditions

  2. Structural connectivity within the default mode network [Baseline and 12 weeks later]

    White matter connectivity within the default mode network during DTI scan

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Richard B. Simches Research Center Boston Massachusetts United States 02114
2 Athinoula A. Martinos Center for Biomedical Imaging Charlestown Massachusetts United States 02129

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Angela Fang, Ph.D., MGH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Angela Fang, Assistant Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02808702
Other Study ID Numbers:
  • 1K23MH109593-01
First Posted:
Jun 22, 2016
Last Update Posted:
Sep 2, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Angela Fang, Assistant Professor of Psychology, Massachusetts General Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 2, 2021