NCT03911063

Telemedicine Clinical Trial for Cognitive Behavioral Therapy in Familial Dysautonomia

A Single-Blind Placebo-Controlled Telemedicine Clinical Trial for Cognitive Behavioral Therapy in Familial Dysautonomia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Familial Dysautonomia

Interventions

Type	Name	Description
BEHAVIORAL	CBT sessions	weekly 20-40 min CBT sessions during 8 weeks; 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.
BEHAVIORAL	Talking Sessions	20-40 min talking sessions (i.e., placebo) for 8 weeks; The placebo talking sessions will be performed by an acute care and palliative care board certified, New York State licensed nurse practitioner at the NYU Dysautonomia Center who is familiar with each FD subject enrolling in the study and an expert in familial dysautonomia. The NP will focus the 20-40 minute conversation on typical medical questions and concerns that the FD patient routinely calls the Center to discuss.

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2019-04-10
• Last updated: 2020-04-28

Locations

1 site across 1 country: United States