The Use of SmartPhone App (Kandoo) to Enhance Efficacy of Brief Behavioral Activation in Reducing Mood Disorder Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Depressive Symptoms and Global Functioning
研究概览
简要总结
The current project is a pilot study that seeks to compare the efficacy of Brief Behavioral Activation's treatment-as-usual that uses paper and pencil tools to Kandoo, a digital, gamified version of activity scheduling and self-monitoring, in a diverse sample of youth presenting with clinically significant symptoms of depression. We will compare the level of pre- and post-treatment depressive symptoms in participants, who will participate in an 8-week brief behavioral activation treatment protocol augmented with Kandoo to the pre- and post- treatment depressive symptoms in the control participants, who will participate in 8-week, treatment as usual, brief behavioral activation treatment protocol. To explore treatment response for the clinically significant symptoms, we will obtain pre- and post-treatment measures of depression, global functioning, and patient goals. During the standard clinical intake, additional information will be obtained, including detailed demographics, medical history, mental health status, and social skills. Beyond determining the overall effectiveness of BBA augmented with Kandoo, the sample diversity and availability of clinical behavioral observations of the participants will permit the development of explanatory models of predictive factors for BBA with Kandoo intervention outcomes.
详细描述
Youth depression is one of the most common psychiatric conditions, affecting 1%-3% of prepubertal children and 3%-9% of adolescents. By late adolescence, between 20-25% of youth will have experienced at least one episode of major depression. Conservative prevalence estimates suggest that in a single year, between 12.5% of 12- to 17-year-olds experience symptoms of a major depressive episode5. Accordingly, pediatric mood disorders, including but not limited to major depressive disorder, are a major public health concern. These issues are serious and potentially lethal. In 15 year follow-up research of children with major depression, 4% died by suicide. In 10- to 15-year follow-up research of adolescents with depression, 8% died by suicide1. Individuals who experience depressive episodes in adolescence are at increased risk for at least one recurrent episode in adulthood. Moreover, youth depression is related to a range of additional poor psychiatric, as well as medical outcomes, such as increased risk of suicidality, higher risk for comorbid psychiatric conditions (e.g., anxiety, substance use, etc.), increased risk of obesity, type 2 diabetes, etc.
Adolescence is a pivotal developmental period that is characterized by the understanding and building of relationships, exploration of interests, development of essential skills needed for adaptive living and professional success, and the transition to higher education and/or the workforce. Depression interferes with these processes and has long-term impact on socioeconomic status, as well as a myriad of psychosocial outcomes: relationship challenges (e.g., familial, peer, romantic, etc.), less perceived social support, lower academic achievement, and attainment, and unemployment2. Even after spontaneous remission or a successful course of treatment, given depressive sequelae (i.e., underdeveloped coping skills, dysfunctional thinking patterns, cognitive distortions, impaired interpersonal relationships, etc.), individuals often require long-term treatment1. Even though treatment for depression is largely effective and untreated depression is associated with more severe prognostic consequences, most individuals with depression do not receive treatment3.
Only about one-third of youth exhibiting clinical psychiatric and behavioral issues access professional care. Low treatment utilization is associated with systematic difficulties (e.g., cost, waitlists, etc.), perceptions towards care providers and the treatment process, issues with the recognition and understanding of psychiatric conditions and related treatment, and characteristics of family systems. Key access to care challenges includes high demands for specialists' services and extensive waitlists5. Decreasing obstacles and increasing facilitators are critical to facilitating youths' access to much needed clinical services. In addition, youth report a range of their own perceptions (e.g., embarrassment, previous experiences, negative expectations, preference to be self-reliant, societal stigma, confidentiality concerns, etc.) as factors that impede their help seeking behaviors and psychiatric health.
Behavioral models of depression maintain that symptoms emerge as an individual has decreased positive experiences and increased negative experiences. As this pattern repeats, activity levels decrease and low mood intensifies, initiating the 'vicious cycle' of depression. Brief Behavioral activation (BBA) has three aims, which are accomplished through activity scheduling and self-monitoring. The first aim is to decrease non-adaptive behaviors, such as avoidance, that maintain depressive symptoms. The second aim is to increase valued, adaptive activities that decrease depressive symptoms. The third aim is problem solving focused on any obstacles and impediments to completing valued adaptive activities. By increasing participation in preferred and rewarding activities, BBA breaks the aforementioned vicious cycle. As participation in preferred and valued activities increases, the individual is reinforced, leading to decreased depressive symptoms. Research demonstrates that BBA is clinically effective at decreasing depressive symptoms in adults and adolescents. The treatment has outcomes consistent with other established depression treatments (e.g., cognitive behavioral therapy, interpersonal therapy, etc.)12.
An essential component of BBA is "homework," which involves participating in an engaging, pleasurable activity, as well as pre- and post-assignment mood tracking. Despite this positive relationship between homework adherence and treatment outcomes, homework completion is consistently low. For youth, although highly variable, completion rates are approximately 50%; this often declines as the treatment sessions progress. Although between session tasks are formulated with the goal of completion, adherence is dependent on the patient's willingness and capacity to independently accomplish the activity. Many factors interfere with independent completion of homework: lack of real time clinician encouragement, live feedback, and support for troubleshooting. Youth report that they value homework and know that it is important for treatment success; however, they concurrently indicate that they do not complete tasks because of low motivation, no interest, lack of support, as well as the perception that the assignments are time consuming. With increased support, such as through an engaging, digital, game-like format, assignment adherence may improve13.
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
- None
入排标准
- 年龄范围
- 13 Years 至 25 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 13.0 to 25:11 years old
- •Sex: male and female
- •Currently enrolled as a patient in the CMI clinic or Fort Health Virtual Outpatient Mental Health Clinic
- •Current clinical presentation must include symptoms of mild-to-moderate depression, two of which must be depressed/irritable mood most of the day and markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day
- •Access to a smart device
- •Internet connectivity
- •Approval by parents and clinician for participants 13-17.11; approval by clinician for participants 18+
排除标准
- •Current exclusionary psychiatric conditions are (not others):
- •eating disorder
- •manic episode (any current or history)
- •psychotic episode or psychotic disorder
- •active suicidality
- •Any neurologic impairment that limits the ability to use a touch screen.
研究组 & 干预措施
Brief Behavioral Activation with traditional paper pencil tracking
Participants will use paper and pencil worksheets to track their activities while receiving Brief Behavioral Activation treatment.
Brief Behavioral Activation with Kandoo
Participants will use Kandoo to track their activities while receiving Brief Behavioral Activation treatment.
干预措施: Kandoo (Device)
结局指标
主要结局
Depressive Symptoms and Global Functioning
时间窗: 8 weeks
We will compare the pre- and post-treatment depressive symptoms and global functioning of participants, who completed BBA with Kandoo.
次要结局
- Improvement Factors(8 weeks)
