A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

NCT03013777 | Completed

• 1 other identifier: 16-01823
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysthymia; Anxiety Disorders; Familial Dysautonomia; Paroxysmal Hypertension; Autosomal Recessive Disease

Keywords

Familial dysautonomia

Outcome Measures

Primary Outcomes (3)

• 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.

  8 Weeks

• 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

  8 Weeks

• 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.

  8 Weeks

Study Arms (1)

Cognitive behavioral therapy (CBT)

EXPERIMENTAL

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

Interventions

8-week CBT Program BEHAVIORAL

Cognitive behavioral therapy (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Dysthymic Disorder; Anxiety Disorders; Dysautonomia, Familial

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Primary Dysautonomias; Autonomic Nervous System Diseases; 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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Horacio Kaufmann, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 6, 2017
• Study Start: December 6, 2016
• Primary Completion: July 20, 2018
• Study Completion: July 20, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

US (1)