ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 11 of 55 for:    Recruiting, Not yet recruiting, Available Studies | "Phobic Disorders"

Brain Correlates of Self-Focused Processing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02808702
Recruitment Status : Recruiting
First Posted : June 22, 2016
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Angela Fang, Massachusetts General Hospital

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
Social Phobia Body Dysmorphic Disorder Behavioral: Cognitive-behavioral therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

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




Primary Outcome Measures :
  1. Change from baseline clinical symptoms at 12 weeks [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and 12 weeks later ]
    Functional connectivity within the default mode network during resting state scan

  4. Structural connectivity within the default mode network [ Time Frame: Baseline and 12 weeks later ]
    White matter connectivity within the default mode network during DTI scan

  5. Response latencies during Self vs. Other conditions [ Time Frame: Baseline and 12 weeks later ]
    Difference in average response latencies (in ms) during Self and Other conditions of a self-referential processing task


Other Outcome Measures:
  1. Wisconsin Card Sort Task (WCST) [ Time Frame: Baseline and 12 weeks later ]
    Total number of perseverative responses throughout the task

  2. Interpretation Questionnaire (IQ) [ Time Frame: Baseline and 12 weeks later ]
    Threat interpretation scores in 3 conditions: BDD-related, social-related, and general

  3. Emotion Recognition Task (ERT) [ Time Frame: Baseline and 12 weeks later ]
    Emotion identification accuracy scores and attribution scores in Self- and Other-referent conditions

  4. Mentation Questionnaire [ Time Frame: Baseline and 12 weeks later ]
    Self-reported percentage of time spent thinking about past, future, task-related, and other thoughts during second resting state scan



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women, age 22-45
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808702


Contacts
Contact: Rachel Porth, A.B 617-726-5527 rporth@mgh.harvard.edu

Locations
United States, Massachusetts
Richard B. Simches Research Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rachel Porth, A.B.    617-726-5527    rporth@mgh.harvard.edu   
Athinoula A. Martinos Center for Biomedical Imaging Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Rachel Porth, A.B.    617-726-5527    rporth@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Angela Fang, Ph.D. MGH

Responsible Party: Angela Fang, Assistant Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02808702     History of Changes
Other Study ID Numbers: 1K23MH109593-01 ( U.S. NIH Grant/Contract )
First Posted: June 22, 2016    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
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, Massachusetts General Hospital:
Attention
Cognitive behavioral therapy
Neuroimaging

Additional relevant MeSH terms:
Phobia, Social
Body Dysmorphic Disorders
Phobic Disorders
Anxiety Disorders
Mental Disorders
Somatoform Disorders