A Trial of Cognitive Behavioral Therapy in Familial Dysautonomia

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT03013777

Collaborator

(none)

Enrollment

Location

Arm

19.4

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dysthymia Anxiety Disorders Familial Dysautonomia Paroxysmal Hypertension Autosomal Recessive Disease	Behavioral: 8-week CBT Program	N/A

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.

Study Design

Study Type:

Interventional

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 :

Dec 6, 2016

Actual Primary Completion Date :

Jul 20, 2018

Actual Study Completion Date :

Jul 20, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Patient Health Questionnaire (PHQ-9) depression scale [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.
Rosenberg Self-Esteem Scale [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
State-Trait Anxiety Inventory (STAI) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.