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Brain Correlates of Self-Focused Processing

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02808702
Enrollment
89
Registered
2016-06-22
Start date
2017-05-01
Completion date
2020-03-13
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Dysmorphic Disorder, Social Phobia

Keywords

Attention, Cognitive behavioral therapy, Neuroimaging

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.

Interventions

BEHAVIORALCognitive-behavioral therapy

Twelve weekly sessions of individual cognitive-behavioral therapy

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline clinical symptoms at 12 weeksBaseline and 12 weeks from baselineEvidence of symptom improvement as determined by clinician-administered assessment of body dysmorphic and socially anxious symptoms
Neural activation in the default mode networkBaseline and 12 weeks laterDifference 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 networkBaseline and 12 weeks laterFunctional connectivity within the default mode network during resting state scan
Response latencies during Self vs. Other conditionsBaseline and 12 weeks laterDifference in average response latencies (in ms) during Self and Other conditions of a self-referential processing task

Secondary

MeasureTime frameDescription
Word valence during Self vs. Other conditionsBaseline and 12 weeks laterNumber of positive and negative words endorsed during Self and Other task conditions
Structural connectivity within the default mode networkBaseline and 12 weeks laterWhite matter connectivity within the default mode network during DTI scan

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026