Familial Dysautonomia Clinical Trial
Official title:
A Single-Blind Placebo-Controlled Telemedicine Clinical Trial for Cognitive Behavioral Therapy in Familial Dysautonomia
This is a single-blind, placebo-controlled, telemedicine clinical trial to assess the
efficacy of cognitive behavioral therapy (CBT) in adult patients 18 years and older with
familial dysautonomia (FD) and anxiety and/or depression and/or obsessive compulsive or
related disorders. The trial will enroll 20 adult patients each with FD who have anxiety
and/or depression and/or obsessive compulsive or related disorders by the DSM V criteria.
Enrolled participants will be allocated to receive, in a non-randomized fashion, weekly 5-10
min talking sessions (i.e., placebo) for 8 weeks, followed by weekly 30-60 min CBT sessions
during 8 weeks. Although investigators will be un-blinded to the intervention, participants
will be blinded to the expected effects of each intervention.
Both the talking sessions (i.e., placebo) and CBT sessions will be performed via telemedicine
either via a HIPAA secure telemedicine platform or the telephone based on the preference of
the individual patient. If a patient specifically requests talking or CBT sessions to be
performed in person, this will be accommodated. The use of telemedicine is to accommodate
disability and potential physical limitations of this unique patient population. The CBT
sessions will be supervised by Lily Armstrong, certified mental health therapist and Dr.
Thomas Boes, NYU Clinical Assistant Professor in the Departments of Psychiatric and
Neurology.
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