An Open-Label Pilot Trial of Cognitive Behavioral Therapy in Familial Dysautonomia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-9) depression scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 8-week CBT Program (Behavioral)
结局指标
主要结局
Patient Health Questionnaire (PHQ-9) depression scale
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点