BehaviorPhase 2PRoP-AANCT06632158

Personal Relevance of Psychotherapy for Asian Americans

A Phase 2 study testing MindBoba and Mindshift CBT in people with Behavior and Stress, run by IRIS Media Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Behavior, Stress, Anxiety
What is being tested?: MindBoba and Mindshift CBT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 263 participants
Where: 1 siteUnited States
Study dates: 1 May 2024to 30 Dec 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

United States1 site

IrisEd dba Trifoia
Eugene, Oregon, 97401

Other trials in United States

About this study

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

Read the 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.

Conditions: Behavior, Stress, Anxiety
Being tested: MindBoba, Mindshift CBT
Keywords: Problem-Solving Therapy, Online App, MindBoba
Medical subject headings: Behavior, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06632158
Study group	Role	What they receive
MindBoba	Experimental	Participants will be given access to the MindBoba app for 12 weeks. Receives: Behavioral: MindBoba
Mindshift CBT	Active comparator	Participants will be given access to the Mindshift CBT app for 12 weeks. Receives: Behavioral: Mindshift CBT
Business-as-Usual	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Mental Health Self-Efficacy Scale (MHSES)
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).
Measured: Baseline and 12 weeks
Stress
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).
Measured: Baseline and 12 weeks
Anxiety
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).
Measured: Baseline and 12 weeks
Depression
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).
Measured: Baseline and 12 weeks
Mental Help Seeking Attitudes Scale (MHSAS)
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).
Measured: Baseline and 12 weeks
Knowledge
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).
Measured: 12 weeks
Social Problem-solving - Avoidant
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).
Measured: Baseline and 12 weeks
Social Problem-solving - Rational
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).
Measured: Baseline and 12 weeks
Social Problem-solving - Negative Problem Orientation
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).
Measured: Baseline and 12 weeks
Social Problem-solving - Impulsivity/Carelessness
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).
Measured: Baseline and 12 weeks
Social Problem-solving - Positive Problem Orientation
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).
Measured: Baseline and 12 weeks

Secondary outcomes (6)

Loss of Face
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.
Measured: Posttest (12 weeks)
Motivation to Engage With the Intervention - Intrinsic Subscale
Motivation 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).
Measured: 12 weeks
Motivation to Engage With the Intervention - Identified Regulation Subscale
Motivation 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).
Measured: 12 weeks
Motivation to Engage With the Intervention - External Regulation Subscale
Motivation 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).
Measured: 12 weeks
Motivation to Engage With the Intervention - Amotivation Subscale
Motivation 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).
Measured: 12 weeks
Usability, Content Utility and Validity, and User Satisfaction
Usability, 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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202430 Dec 2024

First posted8 Oct 2024
Study start1 May 2024
Primary completion30 Dec 2024
Study completion30 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BehaviorStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Three-arm design comparing the new intervention (MindBoba) to an active control (Mindshift CBT) and business-as-usual.
Masking: None (open label)
Enrolment: 263 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06632158
Sponsor's protocol ID: 4R44MH125698-02
Acronym: PRoP-AA
Status last verified: Jul 2026
First submitted: 6 Oct 2024
Last updated: 5 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Once the final results of the project are accepted for publication all de-identified final research data and associated codebooks will be made accessible to interested researchers upon request to the PI and archived with the Inter-university Consortium for Political and Social Research (ICPSR).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personal Relevance of Psychotherapy for Asian Americans: A mHealth Problem-solving Intervention to Reduce Stress (PRoP-AA)
ClinicalTrials.gov ID: NCT06632158
Acronym / sponsor ID: PRoP-AA / 4R44MH125698-02
Conditions: Behavior, Stress, Anxiety
Keywords: Problem-Solving Therapy, Online App, MindBoba
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 263 participants (actual)
Lead sponsor: IRIS Media IncUniversity, hospital or other
Study start: 1 May 2024 (actual)
Primary completion: 30 Dec 2024 (actual)
Study completion: 30 Dec 2024 (actual)
First posted: 8 Oct 2024 (actual)
Results: Posted 5 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Three-arm design comparing the new intervention (MindBoba) to an active control (Mindshift CBT) and business-as-usual.

Arm	Type	Receives
MindBoba	Experimental	Behavioral: MindBobaParticipants will be given access to the MindBoba app for 12 weeks.
Mindshift CBT	Active comparator	Behavioral: Mindshift CBTParticipants will be given access to the Mindshift CBT app for 12 weeks.
Business-as-Usual	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MindBobaMindBoba is a smartphone app that uses strategies based on Problem-Solving Therapy to help decrease stress and anxiety, and teach new skills.	Behavioural	MindBoba
Mindshift CBTMindShift® 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.	Behavioural	Mindshift CBT

Primary outcome

Mental Health Self-Efficacy Scale (MHSES)
Time frame: 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).
Stress
Time frame: 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).
Anxiety
Time frame: 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
Time frame: 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).
Mental Help Seeking Attitudes Scale (MHSAS)
Time frame: 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).
Knowledge
Time frame: 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).
Social Problem-solving - Avoidant
Time frame: 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
Time frame: 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
Time frame: 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 - Impulsivity/Carelessness
Time frame: 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).
Social Problem-solving - Positive Problem Orientation
Time frame: 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).

6 secondary outcomes

Loss of Face
Time frame: Posttest (12 weeks)
Motivation to Engage With the Intervention - Intrinsic Subscale
Time frame: 12 weeks
Motivation to Engage With the Intervention - Identified Regulation Subscale
Time frame: 12 weeks
Motivation to Engage With the Intervention - External Regulation Subscale
Time frame: 12 weeks
Motivation to Engage With the Intervention - Amotivation Subscale
Time frame: 12 weeks
Usability, Content Utility and Validity, and User Satisfaction
Time frame: 12 weeks

Results and safety

Results posted to the registry on 5 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MindBoba	87	72
Mindshift CBT	87	77
Business-as-Usual	89	80

Primary outcome: Mental Health Self-Efficacy Scale (MHSES)

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: Score on Scale

Measure	MindBoba n = 72	Mindshift CBT n = 77	Business-as-Usual n = 80
Pretest (Baseline)	7.16 (1.84)	7.39 (1.65)	7.20 (1.68)
Posttest (12 weeks)	7.36 (1.58)	6.95 (1.82)	7.39 (1.58)

MindBoba vs Mindshift CBT: p = 0.021, ANCOVA

Primary outcome: Stress

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: Score on Scale

Measure	MindBoba n = 72	Mindshift CBT n = 77	Business-as-Usual n = 80
Pretest (Baseline)	13.19 (3.90)	12.39 (4.40)	12.24 (3.90)
Posttest (12 weeks)	12.61 (3.49)	13.16 (4.40)	12.86 (4.03)

MindBoba vs Mindshift CBT vs Business-as-Usual: p >.05, ANCOVA

Primary outcome: Anxiety

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: Score on Scale

Measure	MindBoba n = 72	Mindshift CBT n = 77	Business-as-Usual n = 80
Pretest (Baseline)	10.95 (3.37)	10.74 (3.21)	10.64 (3.37)
Posttest (12 weeks)	10.04 (3.20)	10.23 (3.80)	9.69 (2.86)

MindBoba vs Mindshift CBT vs Business-as-Usual: p >.05, ANCOVA

Primary outcome: Depression

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: Score on Scale

Measure	MindBoba n = 72	Mindshift CBT n = 77	Business-as-Usual n = 80
Pretest (Baseline)	11.53 (3.65)	10.42 (3.56)	10.78 (3.77)
Posttest (12 weeks)	10.44 (2.89)	10.97 (4.27)	10.43 (3.54)

MindBoba vs Mindshift CBT: p = .019, ANCOVA

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of the study, up to 12 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
MindBoba	0 of 87 (0%)	0 of 87 (0%)
Mindshift CBT	0 of 87 (0%)	0 of 87 (0%)
Business-as-Usual	0 of 89 (0%)	0 of 89 (0%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Once the final results of the project are accepted for publication all de-identified final research data and associated codebooks will be made accessible to interested researchers upon request to the PI and archived with the Inter-university Consortium for Political and Social Research (ICPSR).

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An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MindBoba and Mindshift CBT in people with Behavior and Stress, run by IRIS Media Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mental Health Self-Efficacy Scale (MHSES) (time frame: Baseline and 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06632158.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.