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Completed

NCT Number: NCT02808702

Brain Correlates of Self-Focused Processing

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

Twelve weekly sessions of individual cognitive-behavioral therapy

Primary outcomes

  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. 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

Secondary outcomes

  1. Word valence during Self vs. Other conditions

    Time frame: 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

    Time frame: Baseline and 12 weeks later

    White matter connectivity within the default mode network during DTI scan

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 22, 2016
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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