Brain Correlates of Self-Focused Processing
1 other identifier
interventional
89
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedStudy Start
First participant enrolled
May 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedOctober 31, 2022
October 1, 2022
2.9 years
June 8, 2016
October 28, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Word valence during Self vs. Other conditions
Baseline and 12 weeks later
Structural connectivity within the default mode network
Baseline and 12 weeks later
Study Arms (1)
Cognitive-behavioral therapy
EXPERIMENTALTwelve weekly sessions of individual cognitive-behavioral therapy
Interventions
Twelve weekly sessions of individual cognitive-behavioral therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (3)
Fang A, Baran B, Feusner JD, Phan KL, Beatty CC, Crane J, Jacoby RJ, Manoach DS, Wilhelm S. Self-focused brain predictors of cognitive behavioral therapy response in a transdiagnostic sample. J Psychiatr Res. 2024 Mar;171:108-115. doi: 10.1016/j.jpsychires.2024.01.018. Epub 2024 Jan 16.
PMID: 38266332DERIVEDFang A, Baran B, Feusner JD, Phan KL, Beatty CC, Crane J, Jacoby RJ, Manoach DS, Wilhelm S. Self-Focused Brain Predictors of Cognitive Behavioral Therapy Response in a Transdiagnostic Sample. medRxiv [Preprint]. 2023 Sep 2:2023.08.30.23294878. doi: 10.1101/2023.08.30.23294878.
PMID: 37693433DERIVEDFang 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.
PMID: 34875086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angela Fang, Ph.D.
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychology
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 22, 2016
Study Start
May 1, 2017
Primary Completion
March 13, 2020
Study Completion
March 13, 2020
Last Updated
October 31, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share