An interventional study of 8-week CBT Program in Dysthymia, Anxiety Disorders and Familial Dysautonomia, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-29.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment
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.
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.
58 studies on the registry are indexed under Dysthymic Disorder; 5 are open to participants now.
This study's enrollment of 15 is below the median of 60 across 49 interventional studies indexed under Dysthymic Disorder.
Browse Dysthymic Disorder studies →NYU Langone Health is the lead sponsor of 1,421 studies on the registry; 254 are open to participants now.
Of its 231 completed or terminated interventional studies of FDA-regulated products, 195 (84%) have results posted.
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Exclusion Criteria:
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
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.
Time frame: 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
Time frame: 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.
Time frame: 8 Weeks
Ran from Dec 2016 to primary completion in Jul 2018, 19 months.
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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