Clinical trial NCT03911063: Telemedicine Clinical Trial for Cognitive Behavioral Therapy in Familial Dysautonomia
Official title: A Single-Blind Placebo-Controlled Telemedicine Clinical Trial for Cognitive Behavioral Therapy in Familial Dysautonomia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Familial Dysautonomia
Keywords: Telemedicine
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of familial dysautonomia (FD).
* DSM-V criteria of major depressive disorder OR anxiety disorder OR obsessive-compulsive behaviors.
* STAI score ≥ 25 OR a PHQ-9 depression scale score ≥ 5 or greater.
* Willing and able to complete 8 sessions of placebo and 8 sessions of CBT.
* If taking an antidepressant it will be maintained at a constant dose throughout study and concurrent talk therapy from another therapist will not be initiated during the study.
* MoCA score of 14 or greater.

Exclusion Criteria:

* Current suicidal attempt or suicidal ideation (subjects with a past history of suicidal ideation or attempt are eligible to participate).
* Patients starting psychoactive medications within 3-months prior to screening.

Primary outcomes:
measure: STAI anxiety score
timeFrame: Baseline
measure: STAI anxiety score
timeFrame: Week 2
measure: STAI anxiety score
timeFrame: Week 9
measure: STAI anxiety score
timeFrame: Week 17
measure: PHQ-9 depression score
timeFrame: Baseline
measure: PHQ-9 depression score
timeFrame: Week 2
measure: PHQ-9 depression score
timeFrame: Week 9
measure: PHQ-9 depression score
timeFrame: Week 17
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Horacio Kaufmann
role: PRINCIPAL_INVESTIGATOR
References: