Anxiety Disorders Clinical Trial
Official title:
An Open-Label Pilot Trial of Cognitive Behavioral Therapy in Familial Dysautonomia
NCT number | NCT03013777 |
Other study ID # | 16-01823 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 6, 2016 |
Est. completion date | July 20, 2018 |
Verified date | January 2019 |
Source | New York University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York University School of Medicine |
United States,
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 |
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