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NCT Number: NCT03013777

A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

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.

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Key information

Conditions

Dysthymia Anxiety Disorders Autonomic Nervous System Diseases Autosomal Recessive Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Depressive Disorder Dysautonomia, Familial Dysthymic Disorder Familial Dysautonomia Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Mental Disorders Mood Disorders Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Paroxysmal Hypertension Peripheral Nervous System Diseases Polyneuropathies Primary Dysautonomias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

8-week CBT Program

Behavioral

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

An Open-Label Pilot Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2017
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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