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
|Condition or disease||Intervention/treatment||Phase|
|Dysthymia Anxiety Disorders Familial Dysautonomia Paroxysmal Hypertension Autosomal Recessive Disease||Behavioral: 8-week CBT Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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
- 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.
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
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Horacio Kaufmann, MD||NYU Langone Health|