A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

NCT ID: NCT03013777

Last Updated: 2019-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-06

Study Completion Date

2018-07-20

Brief Summary

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To determine the effect of cognitive behavioral therapy (CBT) in the severity of anxiety and depression in adult patients with familial dysautonomia. Patients will be enrolled in an 8-week CBT program. All CBT sessions will be done either in person at the NYU Dysautonomia Center or over the phone to help accommodate disability and potential physical limitations of our patient population.

Detailed Description

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Cognitive behavioral therapy (CBT), defined as a program of interventions that utilize education to teach relaxation, healthy coping skills, stress management, assertiveness training in order to help the individual identify and correct maladaptive beliefs in combination with education to help practice symptom reduction and improve quality of life and function. Patients will participate in eight forty-five minute sessions of CBT with a mental health therapist in order to help treat generalized anxiety disorder, anxiety disorder due to another medical condition (familial dysautonomia), major depressive disorder, persistent depressive disorder (dysthymia), substance/medication- induced depressive disorder, depressive disorder due to another medical condition.

Conditions

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Dysthymia Anxiety Disorders Familial Dysautonomia Paroxysmal Hypertension Autosomal Recessive Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cognitive behavioral therapy (CBT)

The patient would participate in eight forty-five minute sessions of CBT with a mental health therapist. Cognitive behavioral therapy (CBT), defined as a program of interventions that utilize education to teach relaxation, healthy coping skills, stress management, assertiveness training in order to help the individual identify and correct maladaptive beliefs in combination with education to help practice symptom reduction and improve quality of life and function.

Group Type EXPERIMENTAL

8-week CBT Program

Intervention Type BEHAVIORAL

Interventions

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8-week CBT Program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of FD (genetically confirmed)
* DSM-V criteria of major depressive disorder OR anxiety disorder
* STAI score ≥ 25 OR a PHQ-9 depression scale score ≥ 5 or greater
* Willing and able to complete 8 CBT sessions
* Maintain constant psychoactive medication through out study and no concurrent talk therapy from another therapist.

Exclusion Criteria

* Currently suicidal or having current suicidal ideations
* Currently under psychiatric treatment for depression or anxiety
* Have started any psychoactive medication within 3 months prior to screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Horacio Kaufmann, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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16-01823

Identifier Type: -

Identifier Source: org_study_id

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