Randomized Clinical Trial of iTEST: A Blended Intervention Targeting Introspective Accuracy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 3
- 主要终点
- Informant-Rated Specific Level of Function (SLOF) Scale
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a psychosocial intervention called iTEST for people with psychotic disorders that targets introspective accuracy, or the ability to accurately gauge ones abilities. iTEST combines daily cognitive training on a mobile device with coaching that addresses recovery goals. In this trial, we will randomize people to one of two interventions conditions, iTEST or a control condition that receives coaching and cognitive training that does not emphasize introspective accuracy. Both interventions will take place over 12 weeks and participants will be asked to complete assessments at baseline, 6 weeks, 12 weeks, and 24 weeks. The primary outcome of the study is community functioning. Participants will be from three metropolitan areas: San Diego, Dallas, or Miami.
详细描述
This NIH-supported clinical trial is the second phase of a two-phase program, funded by Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders, R61/R33. The overarching goal of this second R33 phase is to evaluate the replicability of R61 findings in a larger randomized control trial with iTEST, a new blended mobile intervention that is aimed at improving introspective accuracy (IA) in people with psychotic disorders, vs. a control condition that is time-equivalent but does not train in introspective accuracy. Introspective accuracy is the degree to which one's self-assessment of performance or abilities corresponds with objective data. Recent research indicates that poor IA is an independent predictor of functional disability. Yet, there are currently no treatments that directly target IA. Basic experimental research and other lines of evidence suggest IA is malleable, and that improvement in task-based IA transfers to untrained tasks. The investigators have developed and completed usability testing of iTEST, a novel blended IA targeted mobile intervention. iTEST integrates graduated drill-and-practice training in IA delivered on a mobile device with personalized coaching in applying IA to everyday compensatory behaviors. In the R61 open trial phase, people with psychotic disorders with at least minimal functional impairment were recruited and found that the intervention led to clinically significant changes in task-based IA along with transfer to an untrained task (target mechanisms). It was determined that the dose of intervention needed to achieve clinically significant improvement in IA targets was achieved at 12 weeks. Therefore, in this trial phase R33, the intervention will last for 12 weeks with a 3-month follow-up. A total of 201 persons who are diagnosed with schizophrenia or schizoaffective disorder will be recruited into this trial
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 as measured by the UCSD Brief Assessment of Capacity to Consent (UBACC)
- •Age 18 to 65;
- •DSM-5 diagnosis of schizophrenia or schizoaffective disorder based on a structured diagnostic interview and available medical record review;
- •≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (needed to read instructions on device);
- •Stable co-treatments (no hospitalizations or medication class changes in 2 months before enrollment). The investigators will determine symptom and medication stability by best-estimate history with information from medical records;
- •Availability of a clinician (staff member, case manager, other mental health clinician) or close associate (family member, friend) with at least monthly contact who can be their informant
- •Minimum level of functional impairment based on milestones, excluding participants who are full-time employed and financially responsible for their household.
排除标准
- •Greater than moderate disorganization on the Positive and Negative Syndrome Scale (P2-Disorganization item >5)
- •DSM-5 alcohol or substance dependence in past 3 months based on interview
- •Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness); 4) Unable to adequately see or manually manipulate a smartphone.
研究组 & 干预措施
iTEST
iTEST includes 6 weeks of weekly coaching sessions that last for 60 minutes each delivered by telehealth or in person per the participant's preference, followed by 3 bi-weekly 30 minute booster telephone calls. ITEST also includes daily cognitive tasks that involve task of memory for words or recognizing facial emotions. Participants guess the number correct after each task and are provided feedback on the accuracy of their guesses. These tasks occur once per day days per week and continue occur over 12 weeks.
干预措施: iTEST (Behavioral)
Active Control
The control condition includes 6 weeks of weekly coaching sessions that last for 60 minutes each delivered by telehealth or in person per the participant's preference, followed by 3 bi-weekly 30 minute booster telephone calls. Participants also complete daily cognitive tasks that involve task of memory for words or recognizing facial emotions. Participants are provided feedback their performance. These tasks occur once per day days per week and continue occur over 12 weeks.
干预措施: Active Control (Behavioral)
结局指标
主要结局
Informant-Rated Specific Level of Function (SLOF) Scale
时间窗: Change from baseline to 3 month follow up
Measure of participant's community functioning rated by an informant. Scale scores range from 43 to 215 with higher scores reflecting better functioning.
次要结局
未报告次要终点
研究者
Colin Depp
Professor
University of California, San Diego