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临床试验/NCT06632158
NCT06632158已完成2 期

Personal Relevance of Psychotherapy for Asian Americans: A mHealth Problem-solving Intervention to Reduce Stress (PRoP-AA)

IRIS Media Inc2 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
263
试验地点
2
主要终点
Social problem-solving

研究概览

简要总结

Using a three-armed design the investigators will test whether participants in the Mindboba online application experience significantly greater improvements as compared to participants in the active control (online app based on Cognitive Behavioral Therapy) and participants in the business-as-usual control. The outcome measures are self-reported social problem-solving, self-efficacy, stress, depression, anxiety, attitudes towards seeking mental health, and knowledge.

详细描述

The intervention, Personal relevance of psychotherapy for Asian Americans: A mHealth problem-solving intervention to reduce stress, is designed 1) to increase the use of mental health services by a population that uses them at one third the rate of Whites,and 2) to develop a personally-relevant approach to stress-reduction. Practical and cultural barriers inhibit the use of mental health services by Asian Americans including a lack of fluency in English amongst specific subpopulations, insufficient health literacy, and stigma surrounding mental illness which stems from Asian American cultural beliefs shared across subpopulations. To this end the investigators developed MindBoba a mHealth (mobile health) application that is systematically adapted to be culturally relevant to select Asian American subpopulations based on Problem-Solving Therapy (PST).

To ensure client engagement, psychotherapy should provide relevant, immediate, and tangible benefits. Personally relevant, evidence-based interventions have the potential to increase the reach and impact of mental health services-especially as conventional, evidence-based interventions have not worked to eliminate mental health disparities among ethnic minority groups. Personally relevant interventions can reduce disparities by increasing engagement, and greater engagement makes mental health services more effective. An external problem-solving orientation is culturally responsive to Asian values. It focuses on the problem, allowing the client to feel more comfortable in treatment, rather than on cognitive reframing, which can elicit an aversive reaction if the client is unprepared to make internal shifts and feels blamed when asked by the therapist to do so. By approaching personal issues as external problems to solve, as opposed to a personal disease to manage, Asian Americans can effectively save face, a particular concern. PST is effective for reducing psychopathology, such as depression and other psychological difficulties. Research has shown that Asian Americans report greater perceived relevance of PST, as well as greater activation of self-processing, in the medial prefrontal cortex compared to Cognitive Behavioral Therapy (CBT).

The MindBoba intervention's content is innovative, it integrates external problem-solving and goal-setting through the use of PST. By focusing on stressful problems in the real world, PST offers a more personally relevant approach for many Asian Americans-particularly those concerned about saving face. Mindboba was culturally adapted for this group systematically. Culturally adapted strategies may include providing cultural-clinical bridges through a comprehensive therapy orientation, focus on stigma reduction, integration of cultural metaphors and symbols, and use of cultural and philosophical teachings.

The final evaluation of intervention efficacy will be conducted via a randomized controlled trial with 360 Asian American participants. Over 14 weeks (1 week for pretest + 12 weeks for intervention + 1 week for posttest), the investigators will assess whether, compared to a business-as-usual (BAU) or an active control (AC), implementation of the full PRoP-AA intervention: (a) increases social problem-solving, (b) increases participant self-efficacy, (c) decreases stress and depression, (d) increases motivation to engage with the intervention, (e) improves attitudes towards seeking mental health help, and (f) increases knowledge.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chinese American
  • ability to understand English, Mandarin, or Cantonese
  • has access to a mobile device running Android or iOS

排除标准

  • 未提供

研究组 & 干预措施

Business-as-Usual

No Intervention

MindBoba

Experimental

Participants will be given access to the MindBoba app for 12 weeks.

干预措施: MindBoba (Behavioral)

Mindshift CBT

Active Comparator

Participants will be given access to the Mindshift CBT app for 12 weeks.

干预措施: Mindshift CBT (Behavioral)

结局指标

主要结局

Social problem-solving

时间窗: Baseline and 12 weeks

Social problem-solving will be measured using the Social Problem-Solving Inventory-Revised: Short Form (SPSI-R).The SPSI-R: Short Form is a 25-item multi-dimensional measure of social problem solving derived from a factor analysis of the original 70-item theory-driven Social Problem-Solving Inventory. In addition to a total score, it consists of five scales that measure two constructive dimensions (positive problem orientation, rational problem solving) and three dysfunctional dimensions (negative problem orientation, impulsivity/carelessness style, avoidance style).

Self-Efficacy

时间窗: Baseline and 12 weeks

Self-efficacy will be measured using the Mental Health Self-Efficacy Scale (MHSES), a 6-item Likert-type single-factor scale measuring one's capability to perform behaviors related to mental health. The MHSES has demonstrated good internal reliability (alpha = .89) and is positively correlated with work, social adjustment, and emotional stability, and negatively correlated with measures of depression.

Attitudes towards seeking mental help

时间窗: Baseline and 12 weeks

Attitudes towards seeking mental help will be assessed using the Mental Help Seeking Attitudes Scale (MHSAS) and the Perceived Devaluation and Discrimination Scale (PDD). The MHSAS a 9-item scale that measures participants' overall attitudes (positive or negative) towards seeking help from a mental health expert. The PDD is a 12-item scale that assesses stigma around mental health. Both the MHSAS and the PDD have demonstrated good internal consistency and test-retest reliability. The PDD has been used translated into Chinese.138 In addition to these two scales, the investigators will develop items to assess participants' attitudes towards using mHealth mental health applications specifically.

Anxiety

时间窗: Baseline and 12 weeks

Anxiety will be assessed using the Depression Anxiety and Stress Scale-21 (DASS-21).The DAS-21 is a 21-item scale that measures three related negative states of depression, anxiety, and stress. It has shown strong internal reliability and moderate validity through confirmatory factor analysis. The reported data uses the total of the 7 items on the anxiety subscale scale with a possible range of 7 to 28, with higher scores indicating significantly higher anxiety (higher are worse outcomes).

Depression

时间窗: Baseline and 12 weeks

Depression will be assessed using the Depression Anxiety and Stress Scale-21 (DASS-21).128 The DAS-21 is a 21-item scale that measures three related negative states of depression, anxiety, and stress. It has shown strong internal reliability and moderate validity through confirmatory factor analysis. The reported data uses the total of the 7 items on the depression subscale scale with a possible range of 7 to 28, with higher scores indicating significantly higher depression (higher are worse outcomes).

Knowledge

时间窗: 12 weeks

Knowledge was measured using a 14-item multiple-choice survey that the project developed to determine the extent to which participants understand basic information delivered in the program around Problem-Solving Therapy skills and content. Total correct answers are reported, with possible range of 0 to 14. Higher scores indicate more correct (higher are better outcomes).

Stress

时间窗: Baseline and 12 weeks

Stress will be assessed using the Depression Anxiety and Stress Scale-21 (DASS-21).128 The DAS-21 is a 21-item scale that measures three related negative states of depression, anxiety, and stress. It has shown strong internal reliability and moderate validity through confirmatory factor analysis. The reported data uses the total of the 7 items on the depression subscale scale with a possible range of 7 to 28, with higher scores indicating significantly higher stress (higher are worse outcomes).

Social Problem-solving - Impulsivity/Carelessness

时间窗: Baseline and 12 weeks

Social problem-solving will be measured using the Social Problem-Solving Inventory-Revised: Short Form (SPSI-R).The SPSI-R: Short Form is a 25-item multi-dimensional measure of social problem solving derived from a factor analysis of the original 70-item theory-driven Social Problem-Solving Inventory. In addition to a total score, it consists of five scales that measure two constructive dimensions (positive problem orientation, rational problem solving) and three dysfunctional dimensions (negative problem orientation, impulsivity/carelessness style, avoidance style). This analysis is of the average of the 5 impulsivity/carelessness style subscale items with a possible range of 1 to 5, with higher scores indicating more use of avoidant strategies (higher are worse outcomes).

Mental Health Self-Efficacy Scale (MHSES)

时间窗: Baseline and 12 weeks

Self-efficacy will be measured using the Mental Health Self-Efficacy Scale (MHSES),127 a 6-item Likert-type single-factor scale measuring one's capability to perform behaviors related to mental health. The MHSES has demonstrated good internal reliability (alpha = .89) and is positively correlated with work, social adjustment, and emotional stability, and negatively correlated with measures of depression. The reported data uses the average of the 6 items on the scale with a possible range of 1 to 10, with higher scores indicating significantly greater self-efficacy (higher are better outcomes).

Mental Help Seeking Attitudes Scale (MHSAS)

时间窗: Baseline and 12 weeks

Attitudes towards seeking mental help will be assessed using the Mental Help Seeking Attitudes Scale (MHSAS). The MHSAS a 9-item scale that measures participants' overall attitudes (positive or negative) towards seeking help from a mental health expert. The average of the 9-item scales are reported, with a possible range of 1 to 7, with higher scores indicating more positive attitudes (higher are better outcomes).

Social Problem-solving - Avoidant

时间窗: Baseline and 12 weeks

Social problem-solving will be measured using the Social Problem-Solving Inventory-Revised: Short Form (SPSI-R).The SPSI-R: Short Form is a 25-item multi-dimensional measure of social problem solving derived from a factor analysis of the original 70-item theory-driven Social Problem-Solving Inventory. In addition to a total score, it consists of five scales that measure two constructive dimensions (positive problem orientation, rational problem solving) and three dysfunctional dimensions (negative problem orientation, impulsivity/carelessness style, avoidance style). This analysis is of the average the 5 avoidant subscale items with a possible range of 1 to 5, with higher scores indicating more use of avoidant strategies (higher are worse outcomes).

Social Problem-solving - Rational

时间窗: Baseline and 12 weeks

Social problem-solving will be measured using the Social Problem-Solving Inventory-Revised: Short Form (SPSI-R).The SPSI-R: Short Form is a 25-item multi-dimensional measure of social problem solving derived from a factor analysis of the original 70-item theory-driven Social Problem-Solving Inventory. In addition to a total score, it consists of five scales that measure two constructive dimensions (positive problem orientation, rational problem solving) and three dysfunctional dimensions (negative problem orientation, impulsivity/carelessness style, avoidance style). This analysis is of the average of the 5 rational subscale items with a possible range of 1 to 5, with higher scores indicating more use of rational strategies (higher are better outcomes).

Social Problem-solving - Negative Problem Orientation

时间窗: Baseline and 12 weeks

Social problem-solving will be measured using the Social Problem-Solving Inventory-Revised: Short Form (SPSI-R).The SPSI-R: Short Form is a 25-item multi-dimensional measure of social problem solving derived from a factor analysis of the original 70-item theory-driven Social Problem-Solving Inventory. In addition to a total score, it consists of five scales that measure two constructive dimensions (positive problem orientation, rational problem solving) and three dysfunctional dimensions (negative problem orientation, impulsivity/carelessness style, avoidance style). This analysis is of the average of the 5 negative problem orientation subscale items with a possible range of 1 to 5, with higher scores indicating more use of avoidant strategies (higher are worse outcomes).

Social Problem-solving - Positive Problem Orientation

时间窗: Baseline and 12 weeks

Social problem-solving will be measured using the Social Problem-Solving Inventory-Revised: Short Form (SPSI-R).The SPSI-R: Short Form is a 25-item multi-dimensional measure of social problem solving derived from a factor analysis of the original 70-item theory-driven Social Problem-Solving Inventory. In addition to a total score, it consists of five scales that measure two constructive dimensions (positive problem orientation, rational problem solving) and three dysfunctional dimensions (negative problem orientation, impulsivity/carelessness style, avoidance style). This analysis is of the average of the 5 positive problem orientation subscale items with a possible range of 1 to 5, with higher scores indicating more use of avoidant strategies (higher are better outcomes).

次要结局

  • Loss of face(Baseline and 12 weeks)
  • Motivation to engage with the intervention(12 weeks)
  • Usability, content utility and validity, user satisfaction, and cultural relevance(12 weeks)
  • Loss of Face(Posttest (12 weeks))
  • Motivation to Engage With the Intervention - Intrinsic Subscale(12 weeks)
  • Motivation to Engage With the Intervention - Identified Regulation Subscale(12 weeks)
  • Motivation to Engage With the Intervention - External Regulation Subscale(12 weeks)
  • Motivation to Engage With the Intervention - Amotivation Subscale(12 weeks)
  • Usability, Content Utility and Validity, and User Satisfaction(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jordan Pennefather

Senior Scientist

IRIS Media Inc

研究点 (2)

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