NST-SPARK: Preliminary Study of an Augmented Reality (AR) App Delivering Recovery-Oriented Cognitive Therapy for Negative Symptoms in Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acceptability of NST-SPARK
研究概览
简要总结
This study evaluates the feasibility and acceptability of a prototype for NST-SPARK (version 1.5). This is an augmented reality (AR) mobile phone application that uses Recovery-oriented Cognitive Therapy (CT-R) to target negative symptoms of schizophrenia.
NST-SPARK uses a game AR activity to recapitulate the beginning activation and engagement phase of each CT-R session as per standardized practices for this therapeutic modality.
详细描述
The specific beliefs targeted during each module are queried before engaging in the AR activity to obtain participant buy in. A self-assessment is taken before and then subsequent prompts challenge these beliefs over the course of the activity. After completion of the AR activity the self-assessment is performed again and the results are compared against the pre-activity responses.
The responses received pre- and then post- activity determine the responses SPARK provides to the participant.
Example: Question: How ambitious or motivated do you feel now?
If the post activity response shows a higher level of motivation compared to the pre-activity assessment the participant will receive the following: So you felt more motivated and more energized! And you did more work not less! Like the more you do the better you feel.
The prototype NST-SPARK v.1.5 has 2 modules: 1) SPARK ENERGY and 2) SPARK MOTIVATION, and is an abbreviated experience following the general framework for NST-SPARK.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-5 criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, or unspecified psychotic disorder.
- •Presence of negative symptoms - SANS rating of 2 or higher on either Avolition/Apathy or Anhedonia/Asociality subscale.
- •Capacity to understand the study procedures and provide informed consent.
- •Has dependable access to a device with videoconferencing capability and stable wifi connection which can be accessed by the study iPhone.
- •Proficient in English.
排除标准
- •Recent change in level of care: antipsychotic medication changes in the last 4 weeks OR hospitalization or emergency room/crisis visits in the last 12 weeks.
- •Acute safety risk - any indication of ongoing risk to themselves or others.
- •Substance induced psychotic disorder or primary mood disorder with psychosis.
- •Severe cognitive or physical limitations preventing the participant from being able to independently use NST-SPARK.
研究组 & 干预措施
SSD
The study design for participants with SSD is a single-arm open-label intervention study. We will collect descriptive information on feasibility and acceptability. Changes in defeatist beliefs and attitudes toward behavioral changes will be evaluated by comparing self-reported ratings before the app intervention vs. immediately afterward and at the 1-week follow-up. All visits will be conducted over video conference with a trained research coordinator.
干预措施: SPARK (Device)
结局指标
主要结局
Acceptability of NST-SPARK
时间窗: This measure will be collected twice: 1) at the first study visit, immediately after using the intervention, and 2) at the 1 week follow-up.
Measured by average ratings from the self-reported questionnaire (Acceptability of Intervention Measure, scored from 1-5 with 5 representing the highest level of acceptability).
Feasibility of NST-SPARK
时间窗: This measure will be collected twice: 1) at the first study visit, immediately after using the intervention, and 2) at the 1 week follow-up.
Measured by average ratings from self-reported questionnaire (Feasibility of Intervention Measure - FIM), scored from 1-5 with 5 representing the highest level of feasibility)
Open-ended feedback about the NST-SPARK user experience
时间窗: This measure will be collected twice: 1) at the first study visit, immediately after using the intervention, and 2) at the 1 week follow-up.
Qualitative summary of responses to semi-structured open-ended interview to be conducted with participants, eliciting responses to questions like the following: What are your first impressions? What do you like most about the app? What do you like least about the app or what are some areas that need to be improved? Did you experience any negative effects from using the app? For example, dizziness, vertigo, or changes in your symptoms? Do you think you'd be able to use this app from a technical perspective? Does it seem simple enough to operate? If no, which parts seemed confusing or difficult? (Imagine that we added similar but more elaborate experiences for a 12-week long experience, and also provided guides for reaching your goals in the real world.) Would you use this app if your doctor prescribed it for you? What makes you say that?
次要结局
- Changes in defeatist beliefs(This measure will be collected three times: 1) at the first study visit, before using the intervention, 2) at the first study visit, immediately after using the intervention, and 3) at the 1 week follow-up.)
- Attitude toward goal-oriented activities(This measure will be collected three times: 1) at the first study visit, before using the intervention, 2) at the first study visit, immediately after using the intervention, and 3) at the 1 week follow-up.)
- Changes in Self Esteem(This measure will be collected three times: 1) at the first study visit, before using the intervention, 2) at the first study visit, immediately after using the intervention, and 3) at the 1 week follow-up.)