Social PhobiaNCT02808702
Brain Correlates of Self-Focused Processing
A study testing Cognitive-behavioral therapy in people with Social Phobia and Body Dysmorphic Disorder, run by Massachusetts General Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Phobia, Body Dysmorphic Disorder
- What is being tested?
- Cognitive-behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2017to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Washington
Seattle, Washington, 98195
About this study
Official title: Brain Correlates of Self-Focused Processing as a Biomarker of Treatment Response
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.
Read the 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.
- Conditions
- Social Phobia, Body Dysmorphic Disorder
- Being tested
- Cognitive-behavioral therapy
- Keywords
- Attention, Cognitive behavioral therapy, Neuroimaging
- Medical subject headings
- Phobia, Social, Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral therapyBehavioural
Twelve weekly sessions of individual cognitive-behavioral therapy
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral therapy | Experimental | Twelve weekly sessions of individual cognitive-behavioral therapy Receives: Behavioral: Cognitive-behavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 12 weeks later
Secondary outcomes (2)
Word valence during Self vs. Other conditions
Number of positive and negative words endorsed during Self and Other task conditions
Measured: Baseline and 12 weeks later
Structural connectivity within the default mode network
White matter connectivity within the default mode network during DTI scan
Measured: Baseline and 12 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start1 May 2017
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social PhobiaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Fang, Massachusetts General Hospital
- Investigators
- Angela Fang, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808702
- Sponsor's protocol ID
- 1K23MH109593-01
- Status last verified
- Oct 2022
- First submitted
- 8 Jun 2016
- Last updated
- 31 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38266332Fang 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.
PubMed 37693433Fang 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.
PubMed 34875086
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Correlates of Self-Focused Processing as a Biomarker of Treatment Response
- ClinicalTrials.gov ID
- NCT02808702
- Acronym / sponsor ID
- 1K23MH109593-01
- Conditions
- Social Phobia, Body Dysmorphic Disorder
- Keywords
- Attention, Cognitive behavioral therapy, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy | Experimental | Behavioral: Cognitive-behavioral therapyTwelve weekly sessions of individual cognitive-behavioral therapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral therapyTwelve weekly sessions of individual cognitive-behavioral therapy | Behavioural | Cognitive-behavioral therapy |
Primary outcome
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
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
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
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
2 secondary outcomes
Word valence during Self vs. Other conditions
Time frame: Baseline and 12 weeks later
Structural connectivity within the default mode network
Time frame: Baseline and 12 weeks later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Derived from this study: PubMed 38266332Fang 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.
- Derived from this study: PubMed 37693433Fang 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.
- Derived from this study: PubMed 34875086Fang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Fang, Ph.D. principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy in people with Social Phobia and Body Dysmorphic Disorder, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline clinical symptoms at 12 weeks (time frame: Baseline and 12 weeks from baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02808702, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022.