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Personal Relevance of Psychotherapy for Asian Americans

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06632158
Acronym
PRoP-AA
Enrollment
263
Registered
2024-10-08
Start date
2024-05-01
Completion date
2024-12-30
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Behavior, Stress

Keywords

Problem-Solving Therapy, Online App, MindBoba

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALMindBoba

MindBoba is a smartphone app that uses strategies based on Problem-Solving Therapy to help decrease stress and anxiety, and teach new skills.

BEHAVIORALMindshift CBT

MindShift® CBT uses strategies based on Cognitive Behavioural Therapy (CBT) to help participants learn to relax and be mindful, develop more effective ways of thinking, and use active steps to take charge of their anxiety.

Sponsors

IRIS Media Inc
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Three-arm design comparing the new intervention (MindBoba) to an active control (Mindshift CBT) and business-as-usual.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Mental Health Self-Efficacy Scale (MHSES)Baseline and 12 weeksSelf-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).
StressBaseline and 12 weeksStress 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).
AnxietyBaseline and 12 weeksAnxiety 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).
DepressionBaseline and 12 weeksDepression 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).
Mental Help Seeking Attitudes Scale (MHSAS)Baseline and 12 weeksAttitudes 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).
Knowledge12 weeksKnowledge 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).
Social Problem-solving - AvoidantBaseline and 12 weeksSocial 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 - RationalBaseline and 12 weeksSocial 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 OrientationBaseline and 12 weeksSocial 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 - Impulsivity/CarelessnessBaseline and 12 weeksSocial 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).
Social Problem-solving - Positive Problem OrientationBaseline and 12 weeksSocial 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).

Secondary

MeasureTime frameDescription
Loss of FacePosttest (12 weeks)Loss of face will be examined as a moderator of the effect of the program, and will be measured using the Loss of Face scale (LOF). The LOF is a 21-item, 7-point Likert-type scale that evaluates concern about violating social norms and concern about causing others to lose face. The LOF has demonstrated good internal reliability (alpha = .83), as well as concurrent and discriminant validity (correlating with other-directedness, private and public self-consciousness, and social anxiety). The LOF has been translated into Chinese. The average of the 21-item scale is reported with a possible range of 1 to 7, with higher scores indicating more concern over loss of face.
Motivation to Engage With the Intervention - Intrinsic Subscale12 weeksMotivation to engage with the intervention will be assessed using the Situational Motivation Scale (SIMS). The SIM is a 16-item Likert-type scale with four internally consistent factors (alphas \> .77): intrinsic motivation, identified regulation, external regulation, and motivation. The SIMS has been used extensively to evaluate motivation in many contexts and towards many activities, including mandated training, and has been translated into Chinese. The average score on the 4 items of the Intrinsic Subscale are reported here, with a possible range of 1 to 7, with higher scores indicating greater intrinsic motivation (higher are better outcomes).
Motivation to Engage With the Intervention - Identified Regulation Subscale12 weeksMotivation to engage with the intervention will be assessed using the Situational Motivation Scale (SIMS). The SIM is a 16-item Likert-type scale with four internally consistent factors (alphas \> .77): intrinsic motivation, identified regulation, external regulation, and motivation. The SIMS has been used extensively to evaluate motivation in many contexts and towards many activities, including mandated training, and has been translated into Chinese. The average score on the 4 items of the Identified Regulation Subscale are reported here, with a possible range of 1 to 7, with higher scores indicating greater identified regulation (higher are better outcomes).
Motivation to Engage With the Intervention - External Regulation Subscale12 weeksMotivation to engage with the intervention will be assessed using the Situational Motivation Scale (SIMS). The SIM is a 16-item Likert-type scale with four internally consistent factors (alphas \> .77): intrinsic motivation, identified regulation, external regulation, and motivation. The SIMS has been used extensively to evaluate motivation in many contexts and towards many activities, including mandated training, and has been translated into Chinese. The average score on the 4 items of the External Regulation Subscale are reported here, with a possible range of 1 to 7, with higher scores indicating greater identified regulation (higher are worse outcomes).
Motivation to Engage With the Intervention - Amotivation Subscale12 weeksMotivation to engage with the intervention will be assessed using the Situational Motivation Scale (SIMS). The SIM is a 16-item Likert-type scale with four internally consistent factors (alphas \> .77): intrinsic motivation, identified regulation, external regulation, and motivation. The SIMS has been used extensively to evaluate motivation in many contexts and towards many activities, including mandated training, and has been translated into Chinese. The average score on the 4 items of the amotivation Subscale are reported here, with a possible range of 1 to 7, with higher scores indicating greater identified regulation (higher are worse outcomes).
Usability, Content Utility and Validity, and User Satisfaction12 weeksUsability, content utility and validity, user satisfaction, will be assessed using the System Usability Scale (SUS) to assess overall usability, with minor wording changes to align the questions with the product being assessed and the addition of an adjective rating scale to help communicate the numeric results to those less familiar with usability studies. The scores reported are the total of the 10 SUS items each with a range of 0 to 4, then multiplied by 2.5 ending with a total scale score ranging from 0 to 100. Higher scores indicate the app is rated more positively. Comparisons of the MindBoba and MindShift interventions are reported.

Countries

United States

Participant flow

Recruitment details

We assessed the efficacy MindBoba using a repeated-measures RCT with participants identifying as being Asian-American specifically as Chinese and/or Taiwanese, with 263 enrolled and 229 completing. 213 participants identified as Chinese, 26 as Taiwanese, 22 as Chinese and Taiwanese, and 2 from Hong Kong. Upon completion of pretest participants were randomly assigned to condition, with 87 to the MindBoba group, 87 to Mindshift active control, and 89 assigned to a business-as-usual.

Baseline characteristics

Characteristic
Age, Continuous35.60 Years
STANDARD_DEVIATION 11.89
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
87 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
84 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Sex: Female, Male
Female
66 Participants
Sex: Female, Male
Male
19 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 00 / 0
other
Total, other adverse events
0 / 870 / 870 / 89
serious
Total, serious adverse events
0 / 870 / 870 / 89

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026