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A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

Primary Purpose

Dysthymia, Anxiety Disorders, Familial Dysautonomia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
8-week CBT Program
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysthymia focused on measuring Familial dysautonomia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cognitive behavioral therapy (CBT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire (PHQ-9) depression scale
Short, but comprehensive scale that consists specifically to the criteria for diagnosis in the DSM-V. The PHQ-9 is effective and sensitive as an instrument in establishing tentative depressive disorder diagnoses while also assessing severity of depressive symptoms. The brevity and criterion validity of the scale make it an appropriate, dual purpose instrument for assessing the severity of depressive disorder within a clinical trial.
Rosenberg Self-Esteem Scale
10-item questionnaire that objectively measures global self-worth. The Rosenberg Self-Esteem scale is a 10-item questionnaire that objectively measures global self-worth. The Rosenberg self-esteem scale is a 10-item scale scored using a four-point response. The scale has extensive and acceptable reliability and validity, both convergent and discriminant
State-Trait Anxiety Inventory (STAI)
The STAI has 40 items, 20 items for each of the S-Anxiety and T-Anxiety sub scales. The STAI was chosen for brevity while also providing a broad coverage of DSM V diagnostic criteria for anxiety. The STAI has proven efficacy in measuring valid self-reports of anxiety symptoms and propensity for anxiety.

Secondary Outcome Measures

Full Information

First Posted
January 5, 2017
Last Updated
January 25, 2019
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT03013777
Brief Title
A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia
Official Title
An Open-Label Pilot Trial of Cognitive Behavioral Therapy in Familial Dysautonomia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 6, 2016 (Actual)
Primary Completion Date
July 20, 2018 (Actual)
Study Completion Date
July 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysthymia, Anxiety Disorders, Familial Dysautonomia, Paroxysmal Hypertension, Autosomal Recessive Disease
Keywords
Familial dysautonomia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive behavioral therapy (CBT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
8-week CBT Program
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9) depression scale
Description
Short, but comprehensive scale that consists specifically to the criteria for diagnosis in the DSM-V. The PHQ-9 is effective and sensitive as an instrument in establishing tentative depressive disorder diagnoses while also assessing severity of depressive symptoms. The brevity and criterion validity of the scale make it an appropriate, dual purpose instrument for assessing the severity of depressive disorder within a clinical trial.
Time Frame
8 Weeks
Title
Rosenberg Self-Esteem Scale
Description
10-item questionnaire that objectively measures global self-worth. The Rosenberg Self-Esteem scale is a 10-item questionnaire that objectively measures global self-worth. The Rosenberg self-esteem scale is a 10-item scale scored using a four-point response. The scale has extensive and acceptable reliability and validity, both convergent and discriminant
Time Frame
8 Weeks
Title
State-Trait Anxiety Inventory (STAI)
Description
The STAI has 40 items, 20 items for each of the S-Anxiety and T-Anxiety sub scales. The STAI was chosen for brevity while also providing a broad coverage of DSM V diagnostic criteria for anxiety. The STAI has proven efficacy in measuring valid self-reports of anxiety symptoms and propensity for anxiety.
Time Frame
8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horacio Kaufmann, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

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A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

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