A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013777
• Other study ID #: 16-01823
• Status: Completed
• Phase: N/A
• Start date: December 6, 2016
• Est. completion date: July 20, 2018

Study information

• Verified date: January 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 20, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Autonomic Nervous System Diseases
• Autosomal Recessive Disease
• Dysautonomia, Familial
• Dysthymia
• Familial Dysautonomia
• Paroxysmal Hypertension
• Primary Dysautonomias

Intervention

Behavioral:
• 8-week CBT Program

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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