Efficacy of Personalized Mobile Cognitive Behavioral Therapy Targeting Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A.
研究概览
简要总结
This study aims to compare the effectiveness of a standard mobile cognitive behavioral therapy program to a personalized mobile cognitive behavioral therapy program that introduces new skills over a shorter period of time. Participants will use the Maya app for two days per week, at least 20 minutes per day, for six weeks. Assessments will include a weekly check in with a member of the research team, questionnaires, and optional electroencephalographic (EEG) recordings at the beginning and end of the 6-week intervention. The investigators think that that the less burdensome personalized program will be just as effective at improving symptoms of anxiety and depression as the general program.
详细描述
Growing evidence suggests a need for anxiety and mood interventions that can be disseminated easily to adolescents and young adults. The goal of this study is to optimize a mobile application that teaches well-established, research-supported psychotherapeutic techniques to adolescents and young adults who are experiencing symptoms of anxiety, depression, and/or bipolar disorder. The study aims to compare the efficacy of a personalized mobile cognitive behavioral therapy program to a more general mobile cognitive behavioral therapy program.
Study participants will randomly receive one of two versions of Maya, a mobile cognitive behavior therapy (CBT) app for adolescents and young adults: either a standard version that includes a variety of skills typically used in CBT, or a personalized version with skills matched to the participant's symptom profile. In contrast to the general condition, which may introduce new material over all six weeks of the intervention, all new material in the personalized condition will be introduced within the first four weeks. The remaining two weeks in the personalized condition will consist of practicing previously learned skills. Participants will use the Maya app for two days per week, at least 20 minutes per day for six weeks and will complete assessments at baseline, week 4, week 6 (end of intervention), and a follow-up assessment at week 12. Participants may also choose to complete an optional electroencephalographic (EEG) recordings at the baseline and end of intervention (week 6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 25 years.
- •Primary diagnosis of an anxiety, depressive, or bipolar disorder as determined by a score of 4 or greater on the Clinical Severity Rating of the Anxiety Disorders Interview Schedule (ADIS).
- •If an individual is diagnosed with bipolar disorder, they must be currently euthymic or experiencing a depressive episode.
- •Access to an Apple iPhone, iPad, or Android device.
排除标准
- •History of neurologic disorder that may affect the neural systems of interest or participant's ability to participate
- •Lifetime diagnosis of a psychotic disorder.
- •Current hypomanic or manic episode.
- •Currently in cognitive behavior therapy.
- •Change in dose of a psychiatric medication in the past 12 weeks.
- •Initiation of psychotherapy in the past 12 weeks.
- •Intent or plan to attempt suicide.
研究组 & 干预措施
Personalized
Participants receive the personalized Maya app intervention for 6 weeks
干预措施: Personalized MAYA Mobile App (Behavioral)
General Non-Personalized
Participants receive the general MAYA app intervention for 6 weeks
干预措施: General MAYA Mobile App (Behavioral)
结局指标
主要结局
Change in anxiety symptoms from pre-intervention to post-intervention as measured by the HAM-A.
时间窗: Baseline to endpoint [Week 6]
The primary symptom measure for anxiety will be the Hamilton Rating Scale for Anxiety (HAM-A). The HAM-A is a 14-item questionnaire measure of the severity of anxiety symptoms. The items measure both psychic anxiety and somatic anxiety. The scores range from 0 to 56, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Change in depressive symptoms from pre-intervention to post-intervention as measured by HAM-D.
时间窗: Baseline to endpoint [Week 6]
The primary symptom measure for depression will be the Hamilton Rating Scale for Depression (HAM-D). The HAM-D is a 24-item questionnaire measuring the severity of depression symptoms. The scale ranges from 0 to 76, where higher scores indicate higher severity of depressive symptoms.
Change in anxiety symptoms from pre-intervention to post-intervention as measured by the anxiety subscale of the DASS.
时间窗: Baseline to endpoint [Week 6]
Anxiety will be measured by the anxiety subscale of the Depression Anxiety Stress Scale (DASS). The anxiety subscale measures of the severity of anxiety symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no anxiety symptoms.
Change in depressive symptoms from pre-intervention to post-intervention as measured by the depression subscale of the DASS.
时间窗: Baseline to endpoint [Week 6]
Depression will be measured by the depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale measures of the severity of depressive symptoms. The scores range from 0 to 42, where higher scores indicate a greater severity of symptoms and lower scores indicate mild to no symptoms.
次要结局
- Change in anxiety measure scores pre-intervention to post-active learning phase as measured by HAM-A(Baseline to end of active learning phase [week 4])
- Change in anxiety measure scores pre-intervention to post-active learning phase as measured by the anxiety subscale of the DASS.(Baseline to end of active learning phase [week 4])
- Change in depression measure scores pre-intervention to post-active learning phase as measured by HAM-D.(Baseline to end of active learning phase [week 4])
- Change in anhedonia from pre-intervention to post-intervention as measured by TEPS.(Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention])
- Change in depression measure scores pre-intervention to post-active learning phase as measured by the depression subscale of the DASS.(Baseline to end of active learning phase [week 4])
- Change in avoidance from pre-intervention to post-intervention as measured by MEAQ.(Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention])
- Change in social anxiety from pre-intervention to post-intervention as measured by LSAS.(Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention])
- Change in anxiety sensitivity from pre-intervention to post-intervention as measured by ASI.(Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention])
- Change in Negative affect from pre-intervention to post-intervention as measured by PANAS(Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention])
- Bipolar symptoms from pre-intervention to post-intervention as measured by ISS.(Baseline to end of active learning phase [week 4 for personalized intervention and week 6 for the general intervention])