Personal Relevance of Psychotherapy for Asian Americans

NCT06632158 | Completed Phase 2

• 1 other identifier: 4R44MH125698-02
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior; Stress; Anxiety

Keywords

Problem-Solving Therapy; Online App; MindBoba

Outcome Measures

Primary Outcomes (7)

• Social problem-solving

  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).

  Baseline and 12 weeks

• Self-Efficacy

  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.

  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,

  Baseline and 12 weeks

• Anxiety

  Anxiety 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,

  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,

  Baseline and 12 weeks

• Attitudes towards seeking mental help

  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.

  Baseline and 12 weeks

• Knowledge

  Knowledge will be measured using a 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.

  12 weeks

Secondary Outcomes (3)

• 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

Study Arms (3)

MindBoba

EXPERIMENTAL

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

Behavioral: MindBoba

Mindshift CBT

ACTIVE COMPARATOR

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

Behavioral: Mindshift CBT

Business-as-Usual

NO INTERVENTION

Interventions

MindBoba BEHAVIORAL

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

MindBoba

Mindshift CBT BEHAVIORAL

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.

Mindshift CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• IRIS Media Inc: lead

Study Sites (1)

IrisEd dba Trifoia

Eugene, Oregon, 97401, United States

Location

MeSH Terms

Conditions

Behavior; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

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

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: October 8, 2024
• Study Start: May 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the final report of the grant is submitted and associated publications are accepted we will make the de-identified final research data and associated codebooks available within 6 months.

Locations

US (1)