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A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

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ClinicalTrials.gov Identifier: NCT03013777
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Dysthymia Anxiety Disorders Familial Dysautonomia Paroxysmal Hypertension Autosomal Recessive Disease Behavioral: 8-week CBT Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Pilot Trial of Cognitive Behavioral Therapy in Familial Dysautonomia
Actual Study Start Date : December 6, 2016
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : July 20, 2018


Arm Intervention/treatment
Experimental: 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.
Behavioral: 8-week CBT Program



Primary Outcome Measures :
  1. Patient Health Questionnaire (PHQ-9) depression scale [ Time Frame: 8 Weeks ]
    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.

  2. Rosenberg Self-Esteem Scale [ Time Frame: 8 Weeks ]
    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

  3. State-Trait Anxiety Inventory (STAI) [ Time Frame: 8 Weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013777


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Horacio Kaufmann, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03013777    
Other Study ID Numbers: 16-01823
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NYU Langone Health:
Familial dysautonomia
Additional relevant MeSH terms:
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Primary Dysautonomias
Autonomic Nervous System Diseases
Dysautonomia, Familial
Anxiety Disorders
Mental Disorders
Nervous System Diseases
Hereditary Sensory and Autonomic Neuropathies
Nervous System Malformations
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Congenital Abnormalities
Genetic Diseases, Inborn