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Résztvevőt keres itt: Egyesült ÁllamokFázis nélkül

Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety

A legfontosabb adatok

Ki végzi
Boston University Charles River Campus
Hol
Boston (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
240 fő, tervezett
Kezdés
2023. máj. 26.
Várható befejezés
2027. jún. 30.
A vizsgálat típusa
Beavatkozással járó, 3 csoportAz egyik csoport nem kap vizsgálati kezelést, összehasonlításként.
A vizsgált kezelések
  • Group CBT for Social Anxiety Disorder
  • Sertraline
  • Individual CBT for Social Anxiety Disorder
A regiszteradat frissítve
2026. július 23.

Ki vehet részt

Életkor
18 év – 50 év
Nem
Nők és férfiak
Egészséges önkéntesek
Részt vehetnek

A regiszter feltételei, szó szerint

Mind a 19 feltétel megnézéseKevesebb

Ki vehet részt

  • (1) Any gender or race between 18-50 years old
  • Additional inclusion criteria for healthy controls:
  • (1) Liebowitz Social Anxiety Scale (LSAS; Mennin et al., 2002) score <= 30, does not currently meet criteria for an Axis I psychiatric condition, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; American Psychiatric Association, 2013)
  • Additional inclusion criteria for the social anxiety disorder (SAD) group:
  • Outpatients with a primary psychiatric complaint (designated by the patient as the most important source of current distress) of social anxiety with social interaction fear as defined by an Liebowitz Social Anxiety Scale (LSAS) score >= 60
  • Overall clinical severity of at least mild as defined by Clinical Global Impressions Scale (CGI-S; Zaider et al., 2003) of at least 3
  • Medical history interview and laboratory findings without clinically significant abnormalities
  • Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol

Ki nem vehet részt

  • . Patients with significant suicidal ideation Montgomery-Åsberg Depression Rating Scale (10 items, self-report) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention
  • Patients can be taking a concurrent psychotropic medication (e.g., antidepressants, anxiolytics, beta blockers, sertraline), but the dose must be stabilized for at least 2 weeks prior to initiation of randomized treatment
  • Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the social anxiety is excluded. Individuals with prior CBT experience or treatments that included cognitive and behavioral skills and exposure procedures (e.g., assertiveness and social skills trainings) will be excluded. General supportive or insight-oriented therapy initiated > 3 months prior is acceptable
  • Prior non-response to adequately-delivered exposure (i.e., as defined by the patient's report of receiving specific and regular exposure assignments as part of a previous treatment)
  • Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, braces, or claustrophobia
  • A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or obsessive-compulsive disorder; an eating disorder in the past 6 months; organic brain syndrome, intellectual disability, or other cognitive dysfunction that could interfere with capacity to engage in therapy; a history of substance or alcohol abuse or dependence (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol, marijuana, and stimulant use during the acute period of study participation
  • Serious medical illness, associated treatment, or other instability for which hospitalization may be likely within the next year, or which may alter fMRI or EEG measurements. Participants with a history of serious medical illness or treatments that may alter fMRI measurements may enroll in the study 12 months after the condition has been remitted and ending treatment
  • Patients with a current or past history of seizures
  • Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment
  • Significant personality dysfunction likely to interfere with study participation
  • Pregnant women, lactating women, and women of childbearing potential who may become pregnant

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 50 év között vagy?

Helyszínek itt: Egyesült Államok

  • Center for Anxiety and Related Disorders at Boston UniversityBoston, Egyesült ÁllamokContact: Anthony Rosellini, PhDRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

The purpose of this clinical trial is to answer the question: can the investigators predict which adults with social anxiety disorder (SAD) will successfully respond to treatment? To answer this question, the investigators plan to recruit 190 adult participants who experience extreme forms of social anxiety to undergo brain imaging before and after 12 weeks of group cognitive behavioral therapy (CBT). Adults in the SAD group who do not respond enough to group CBT may be offered the opportunity to complete an additional 12 weeks of individual CBT while receiving SSRI medication (sertraline, see below) for SAD.

A teljes eredeti leírásKevesebb

Data collected from participants who experience anxiety will be compared to a group of 50 participants with little or no social anxiety, who will serve as a comparison group.

A vizsgálat 3 csoportja

  • RespondersA vizsgált kezelés

    The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder.

    Kezelés: Group CBT for Social Anxiety Disorder

  • Non-RespondersA vizsgált kezelés

    The experimental arm involves EEG + MRI before and after exposure therapy for social anxiety disorder. Non-responders to initial exposure therapy will receive sertraline and additional exposure therapy prior to final EEG and MRI.

    Kezelés: Group CBT for Social Anxiety Disorder, Sertraline és Individual CBT for Social Anxiety Disorder

  • ControlsNincs vizsgálati kezelés, összehasonlításként

    Controls will receive baseline EEG and MRI, screening questionnaires and intake interview. They will not participate in therapy but complete weekly symptom measures and a second EEG/MRI session 12 weeks after baseline. Control participants will be compared with social anxiety participants to determine differences in neuro-markers at baseline and over follow-up.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Illeszkedési kérdések
Forrás: NCT05683223: ki vehet részt
A regiszteradat frissítve
2026. július 23.