Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness (R33)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Ecological Momentary Assessment
研究概览
简要总结
This randomized clinical trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.
详细描述
This study evaluates a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social behavior, and it also validates several new techniques for measuring social behavior. mSITE blends brief in-person psychotherapy with a context-triggered mobile smartphone intervention and remote telephone coaching. The investigators will conduct a randomized clinical trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions in comparison to a therapist and device matched condition. The investigators will changes in outcome measures at baseline and Weeks 8, 18, and 30. If found to be effective, a scalable intervention that reduces social isolation in serious mental illness would have significant personal, societal, and economic impact.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary informed consent to participate and capacity to consent; Age 18 to 65;
- •Diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a diagnostic interview and available medical record review;
- •Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;
- •Be willing and able to speak English at ≥ 6th grade reading level (to read intervention workbook).
排除标准
- •Prior cognitive-behavioral therapy in the past 2 years;
- •Greater than moderate disorganization on the PANSS (P2- Disorganization item >5);
- •Alcohol or substance dependence in past 3 months based on the diagnostic interview;
- •Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness);
- •Unable to adequately see or manually manipulate a phone;
- •Resident of an integrated housing facility that also provides treatment services.
研究组 & 干预措施
mobile Social Interaction Therapy by Exposure (mSITE)
mSITE is a blended intervention that integrates a brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching.
干预措施: Mobile Intervention for Social Recovery in Serious Mental Illness (mSITE) (Behavioral)
Supportive Contact (SC)
The SC arm is a contact condition that will provide the same amount of individual in-person and coaching, and mobile device contact as the mSITE condition.
干预措施: Supportive Contact (SC) (Behavioral)
结局指标
主要结局
Ecological Momentary Assessment
时间窗: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
Ecological Momentary Assessment (EMA) is a method of remote data collection that involves repeatedly sampling a participant's current behaviors, thoughts, mood, and experiences in real time, in their natural environments. The primary outcome in this study will be the number of social interactions.
Clinical Assessment Interview for Negative Symptoms
时间窗: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
Measure changes in motivational negative symptoms on the Clinical Assessment Interview for Negative Symptoms (CAINS). The CAINS is a 13-item interview-based assessment of negative symptoms, and each item is rated from 0 (no impairment) to 4 (severe deficit) measuring the two negative symptom factors recommended in consensus reports: Expression and Motivation and Pleasure (MAP) across social, vocational and recreational domains. Total scores for each factor are computed. The range for the MAP is 0 - 36, and the range for the Expression factor is 0 - 16. Higher scores indicate more severe negative symptoms for both factors.
Birchwood Social Functioning Scale
时间窗: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
Measure changes in functioning on the Birchwood Social Functioning Scale (SFS). The SFS is a self-report assessment of functioning with 7 subscales, and each item is rated from 0 to 3 with the exception of the Occupation/Employment subscale if a participant is in regular employment (scores range from 7-10 based upon type of work). The subscales and score ranges are: Social Engagement Withdrawal (0-15), Interpersonal Communication/Relationships (0-30), Prosocial Activities (0-66), Recreation (0-48), Independence-Performance (0-39), Independence-Competence (0-39), and Occupation/Employment (0-10). Higher scores indicate better functioning for all subscales.
Positive And Negative Syndrome Scale
时间窗: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
The Positive And Negative Syndrome Scale (PANSS) is a 30-item interview that provides balanced representation of positive and negative symptoms and gauges their relationship to one another and to global psychopathology. Items are rated 1 (Absent) to 7 (Extreme) and summed across items for a total range of scores of 30-210. Higher scores indicate the presence of more severe symptoms.
Passive sensing mobile application
时间窗: Assess change from baseline in number of social interactions at Weeks 0, 8, 18, and 30.
The passive sensing mobile application will measure the number of conversations. The conversations or specific content will not be recorded.
次要结局
未报告次要终点
研究者
Eric Granholm
Professor
University of California, San Diego